510(k) · Cleared
ClearedOsseospeed Profile EV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Implants Manufacturing GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Oct 25, 2013 as substantially equivalent to K120414 (Astra Tech AB, 2012) and 7 other predicates after a 198-day review. Its family tree reaches back 12 generations to 1990. 18 later devices descend from it.
- Decided
- Oct 25, 2013
- Review
- 198 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K894595 (1990). 153 ancestors in all, the oldest K781060 (1978). 18 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- Descendant · cites it directly · 9 of its ownK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- Descendant · 2 generations on · 8 of its ownK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- Descendant · cites it directly · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 3 generations on · 3 of its ownK203660 TRI-matrix Implant LineTri Dental Implants Int. AG · 2021
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016 · cites it directly9descendants
- K172225Atlantis Abutment for MIS ImplantDentsply Sirona · 2017 · 2 generations on8descendants
- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · cites it directly5descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · cites it directly4descendants
- K203660TRI-matrix Implant LineTri Dental Implants Int. AG · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| 0 (this device) | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| +1 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| +2 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| +1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +1 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +3 | K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | 2021 | — |
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 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (8)
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 |
|---|---|---|---|
| * | K120414 | Osseospeed PlusSummary page 3…edTM Profile EV is substantially equivalent in indications and design principles to the following legally marketed predicate devices: Astra Tech AB, OsseoSpeedTM Pius - K 120414 Astra Tech AB, OsseoSpeedTM Profile, System - K080 156 Astra Tech, Inc., AtlantiSTM Abutment in Zirconia for OsseoSpeed TX Profil… | 2012 |
| * | K080156 | Osseospeed TM Profile SystemSummary page 3…ons and design principles to the following legally marketed predicate devices: Astra Tech AB, OsseoSpeedTM Pius - K 120414 Astra Tech AB, OsseoSpeedTM Profile, System - K080 156 Astra Tech, Inc., AtlantiSTM Abutment in Zirconia for OsseoSpeed TX Profile Implant - K 103759 Astra Tech, Inc., AtlantiSrM Abutm… | 2008 |
| * | K103759 | Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantSummary page 3…OsseoSpeedTM Pius - K 120414 Astra Tech AB, OsseoSpeedTM Profile, System - K080 156 Astra Tech, Inc., AtlantiSTM Abutment in Zirconia for OsseoSpeed TX Profile Implant - K 103759 Astra Tech, Inc., AtlantiSrM Abutment in Zirconia for Astra Tech Osseospeed Plus Implant - KI 112138 Astra Tech AB, Astra Tech Im… | 2011 |
| * | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantSummary page 3…tlantiSTM Abutment in Zirconia for OsseoSpeed TX Profile Implant - K 103759 Astra Tech, Inc., AtlantiSrM Abutment in Zirconia for Astra Tech Osseospeed Plus Implant - KI 112138 Astra Tech AB, Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 10 1732 Atlantis C… | 2011 |
| * | K072624 | Astra Tech Implant System, New ComponentSummary page 3…- K 103759 Astra Tech, Inc., AtlantiSrM Abutment in Zirconia for Astra Tech Osseospeed Plus Implant - KI 112138 Astra Tech AB, Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 10 1732 Atlantis Components, Inc. AtlantiSrM Abutment for Astra Implant - K05 1652 F… | 2007 |
| * | K101732 | Astra Tech Implant SystemSummary page 3…Zirconia for Astra Tech Osseospeed Plus Implant - KI 112138 Astra Tech AB, Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 10 1732 Atlantis Components, Inc. AtlantiSrM Abutment for Astra Implant - K05 1652 FRIADENT GmbH, ANKYLOSO Dental Implant System - K04 15… | 2011 |
| * | K051652 | Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ AbutmentSummary page 3…Astra Tech Implant System, New Component - K072624 Astra Tech AB, Astra Tech Implant System - K 10 1732 Atlantis Components, Inc. AtlantiSrM Abutment for Astra Implant - K05 1652 FRIADENT GmbH, ANKYLOSO Dental Implant System - K04 1509 The subject device and the predicate devices have the same intended use… | 2005 |
| * | K041509 | Ankylos Dental Implant SystemSummary page 3…Tech AB, Astra Tech Implant System - K 10 1732 Atlantis Components, Inc. AtlantiSrM Abutment for Astra Implant - K05 1652 FRIADENT GmbH, ANKYLOSO Dental Implant System - K04 1509 The subject device and the predicate devices have the same intended use and have the same technological characteristics. The sub… | 2004 |
What descends from it? (18)
See all 184 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 153 ancestors have a recall of any class.
- Of its descendants, K160626 (Dentsply Sirona, 2016) has gone furthest, with 9 descendants of its own.
- 26 other devices also cite its predicate K120414.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: * replacing missing teeth in single or multiple unit applications in the mandible or maxilla. * immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge * especially indicated for use in soft bone…
Read the full statement (375 words)
Implants:
The ASTRA TECH Implant System - OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
* replacing missing teeth in single or multiple unit applications in the mandible or 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 and early loading for all indications
* together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
* only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components
Abutments:
ASTRA TECH Implant System - OsseoSpeed EV abutments are intended to be used in conjunction with ASTRA TECH Implant System - OsseoSpeed EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.
The ATLANTIS 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 ATLANTIS Crown Abutment 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.
The ATLANTIS Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.
ATLANTIS Abutment, ATLANTIS Crown Abutment and ATLANTIS Conus Abutment are compatible with ASTRA TECH Implant System Profile EV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130999: Osseospeed Profile EV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130999
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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