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 Feb 23, 2011 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) and 2 other predicates after a 247-day review. Its family tree reaches back 8 generations to 1990. 214 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 247 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894595 (1990). 24 ancestors in all. 214 later devices descend from it, 11 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · cites it directly · 201 of its ownK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · 2 generations on · 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 · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 214 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 214 · See all- K111287Astra Tech Implant SystemAstra Tech AB · 2011 · cites it directly201descendants
- K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · 2 generations on200descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| +1 | 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 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 16 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 27 | 0 |
| 2024 | 31 | 0 |
| 2025 | 35 | 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? (3)
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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…s, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Nobel Biocare NobelActive Internal Connection Implant cleared under K071370, Astra Tech Astra Tech Implant System cleared under K091239, and Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053… | 2007 |
| * | K091239 | Astra Tech Implant SystemSummary page 2…ly equivalent to pre-amendment devices: Nobel Biocare NobelActive Internal Connection Implant cleared under K071370, Astra Tech Astra Tech Implant System cleared under K091239, and Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053384. The subject device and the predicate devices have the s… | 2009 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 2…onents of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically… | 2006 |
What descends from it? (214)
See all 21411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111287 | Astra Tech Implant System | 2011 | 201 |
| K120414 | Osseospeed Plus | 2012 | 196 |
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K130999 | Osseospeed Profile EV | 2013 | 18 |
| K163349 | MIS V3 Conical Connection Dental Implant System | 2017 | 8 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 | 5 |
| K112279 | Quantum Dental Implant System | 2012 | 1 |
| K130787 | Quantum Dental Implant System | 2013 | 0 |
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 1.9 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K111287 (Astra Tech AB, 2011) has gone furthest, with 201 descendants of its own.
- 28 other devices also cite its predicate K071370.
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?
The OsseoSpeed implants 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…
Read the full statement (124 words)
The OsseoSpeed implants 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
together with immediate loading protocol for single-tooth restorations on implants 8 mm
or longer
with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and
central incisors.
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/K101732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101732: Astra Tech Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101732
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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