510(k) · Cleared
ClearedAstra Tech Implant System
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 Sep 26, 2011 as substantially equivalent to K101732 (Astra Tech AB, 2011) and 3 other predicates after a 143-day review. Its family tree reaches back 9 generations to 1990. 201 later devices descend from it.
- Decided
- Sep 26, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K894595 (1990). 26 ancestors in all. 201 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · cites it directly · 200 of its ownK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 1 generation backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- This deviceK111287 Astra Tech Implant SystemAstra Tech AB · 2011
Showing 5 of 201 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 201 · See all- K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · cites it directly200descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 2 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −1 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 15 | 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? (4)
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 |
|---|---|---|---|
| * | K101732 | Astra Tech Implant SystemSummary page 3…te devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Astra Tech AB, Astra Tech Implant System cleared under K101732, Astra Tech AB, Astra Tech Implant System cleared under K09 1239, Astra Tech Inc., Fixture MicroThreadTM OsseoSpeedTM c… | 2011 |
| * | K091239 | Astra Tech Implant SystemSummary page 3…lly equivalent to pre-amendment devices: Astra Tech AB, Astra Tech Implant System cleared under K101732, Astra Tech AB, Astra Tech Implant System cleared under K09 1239, Astra Tech Inc., Fixture MicroThreadTM OsseoSpeedTM cleared uinder K053384, and Altatec GmbH-, CAMLOG Implant System M… | 2009 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 3…stem cleared under K101732, Astra Tech AB, Astra Tech Implant System cleared under K09 1239, Astra Tech Inc., Fixture MicroThreadTM OsseoSpeedTM cleared uinder K053384, and Altatec GmbH-, CAMLOG Implant System Modified Implants and Abutments cleared under K083496. The subject device and… | 2006 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 3…tra Tech Inc., Fixture MicroThreadTM OsseoSpeedTM cleared uinder K053384, and Altatec GmbH-, CAMLOG Implant System Modified Implants and Abutments cleared under K083496. The subject device and the predicate devices have the same intended use, have the same technological characteristics and are ma… | 2009 |
What descends from it? (201)
See all 2013 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 21 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K112138 (Astra Tech, Inc., 2011) has gone furthest, with 200 descendants of its own.
- 10 other devices also cite its predicate K101732.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
OsseoSpeedTM Plus implants of the Astra Tech Implant System Plus are intended to be used: * To replace missing teeth in single or multiple unit applications within the mandible or maxilla * For immediate placement in extraction sites and partially or completely healed alveolar ridge situations * For both one- and two-stage surgical procedures " Especially well in soft bone applications where implants with other implant surface treatments may be less…
Read the full statement (144 words)
OsseoSpeedTM Plus implants of the Astra Tech Implant System Plus are intended to be used:
* To replace missing teeth in single or multiple unit applications within the mandible or maxilla
* For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
* For both one- and two-stage surgical procedures
" Especially well in soft bone applications where implants with other implant surface treatments may be less effective
* 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.
Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111287: Astra Tech Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111287
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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