510(k) · Cleared
ClearedAstra Tech Implant System, New Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 1, 2007 after a 14-day review. The FDA summary names its predicate without a number. 301 later devices descend from it.
- Decided
- Oct 1, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
301 later devices descend from it, 5 citing it directly.
- This deviceK072624 Astra Tech Implant System, New ComponentAstra Tech AB · 2007
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · cites it directly · 123 of its ownK081786 Ziocera & Convertible SystemOsstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 111 of its ownK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- Descendant · 3 generations on · 105 of its ownK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 301 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 301 · See all- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd. · 2008 · cites it directly123descendants
- K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010 · 2 generations on111descendants
- K110308Prosthetic SystemOsstem Implant Co., Ltd. · 2011 · 3 generations on105descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072624 | Astra Tech Implant System, New Component | Astra Tech AB | 2007 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +1 | K081786 | Ziocera & Convertible System | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| +3 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 17 | 0 |
| 2017 | 22 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 25 | 0 |
| 2021 | 24 | 0 |
| 2022 | 25 | 0 |
| 2023 | 41 | 0 |
| 2024 | 40 | 0 |
| 2025 | 36 | 0 |
| 2026 | 20 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Astra Tech Implant System Named without a submission number |
What descends from it? (301)
See all 3015 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?
- Of its descendants, K120414 (Astra Tech AB, 2012) has gone furthest, with 196 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072624: Astra Tech Implant System, New Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072624
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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