510(k) · Cleared
ClearedOsseospeed Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech AB · DZE Implant, Endosseous, Root-Form
Cleared on Jul 31, 2012 as substantially equivalent to K111287 (Astra Tech AB, 2011) and 17 other predicates after a 172-day review. Its family tree reaches back 11 generations to 1990. 196 later devices descend from it.
- Decided
- Jul 31, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 18
Its longest line of descent runs back 11 generations to K894595 (1990). 149 ancestors in all, the oldest K781060 (1978). 196 later devices descend from it, 27 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- This deviceK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · cites it directly · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 1 generation backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- This deviceK120414 Osseospeed PlusAstra Tech AB · 2012
Showing 5 of 196 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 196 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · cites it directly42descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −1 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| 0 (this device) | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +1 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 20 | 0 |
| 2023 | 27 | 0 |
| 2024 | 30 | 0 |
| 2025 | 33 | 0 |
| 2026 | 17 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (18)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111287 | Astra Tech Implant System | 2011 |
| * | K101732 | Astra Tech Implant System | 2011 |
| * | K091239 | Astra Tech Implant SystemSummary page 3…System is substantially equivalent in indications for use and design principles to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K0726… | 2009 |
| * | K080396 | Osseospeed NarrowSummary page 3…s substantially equivalent in indications for use and design principles to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K0632… | 2008 |
| * | K120338 | Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in Zirconia Cleared while this submission was under review Summary page 3…nt in indications for use and design principles to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K9… | 2012 |
| * | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantSummary page 3…ications for use and design principles to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. T… | 2011 |
| * | K111390 | Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0… | 2011 |
| * | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentSummary page 3…design principles to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device an… | 2011 |
| * | K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantSummary page 3…inciples to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the pre… | 2010 |
| * | K101005 | Astra Tech Implant System, New ComponentSummary page 3…to the following legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate de… | 2011 |
| * | K083805 | Ankylos C/X Dental Implant SystemSummary page 3…llowing legally marketed predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices hav… | 2009 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 3…predicate devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use… | 2009 |
| * | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsSummary page 3…e devices: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have… | 2008 |
| * | K072624 | Astra Tech Implant System, New ComponentSummary page 3…: Implants: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have the same… | 2007 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 3…ts: Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have the same technolog… | 2007 |
| * | K980698 | Astra Tech Implants - Dental SystemSummary page 3…Ki 11287, KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have the same technological char… | 1998 |
| * | K974738 | Astra Tech Implant Dental SystemSummary page 3…KIOI 732, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have the same technological characteristi… | 1998 |
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 3…, K091239, K080396. Abutments: K120338, K1 12138, KI 11390, K1 10356, K101849, K101005, K083805, K083496, K081666, K072624, K063286, K980698, K974738, K93 1767. The subject device and the predicate devices have the same intended use and have the same technological characteristics and are… | 1994 |
What descends from it? (196)
See all 19627 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K150295 | LOCATOR RTx | 2015 | 42 |
| K183518 | Preat Abutments | 2019 | 22 |
| K130999 | Osseospeed Profile EV | 2013 | 18 |
| K170398 | S.I.N. Dental Implant System | 2017 | 17 |
| K170392 | S.I.N. Implant System | 2017 | 16 |
| K160244 | VARIOunite | 2016 | 15 |
| K163634 | External Hex Implants | 2017 | 13 |
| K210220 | Kontact Dental Implant System | 2021 | 7 |
| K163060 | Deep Conical (DC) Implants and Accessories | 2017 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 149 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 descendants of its own.
- 2 other devices also cite its predicate K111287.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: * replacing single and multiple missing teeth in the mandible and maxilla, * immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, * especially indicated for use in soft bone applications where implants with other implant…
Read the full statement (287 words)
Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
* replacing single and multiple missing teeth in the mandible and maxilla,
* immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
* especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective,
* immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for OsseoSpeedTM Plus 3.05 is limited to replacement of maxillary lateral incisors and mandibular incisors.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Atlantis Abutments:
The AtlantisTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The AtlantisTM Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120414: Osseospeed Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120414
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026