510(k) · Cleared
ClearedAstra Tech Dental Implants-Ceramic Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 7, 2002 as substantially equivalent to K974738 (Astra Tech, Inc., 1998) and 1 other predicate after a 9-day review. Its family tree reaches back 2 generations to 1994. 307 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 9 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931767 (1994). 3 ancestors in all. 307 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 1 generation backK974738 Astra Tech Implant Dental SystemAstra Tech, Inc. · 1998
- This deviceK023631 Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc. · 2002
- Descendant · cites it directly · 198 of its ownK101005 Astra Tech Implant System, New ComponentAstra Tech AB · 2011
- Descendant · 2 generations on · 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
Showing 5 of 307 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 307 · See all- K101005Astra Tech Implant System, New ComponentAstra Tech AB · 2011 · cites it directly198descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| −1 | K974738 | Astra Tech Implant Dental System | Astra Tech, Inc. | 1998 | — |
| 0 (this device) | K023631 | Astra Tech Dental Implants-Ceramic Abutments | Astra Tech, Inc. | 2002 | — |
| +1 | K101005 | Astra Tech Implant System, New Component | Astra Tech AB | 2011 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 9 | 0 |
| 2016 | 16 | 0 |
| 2017 | 20 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 24 | 0 |
| 2021 | 24 | 0 |
| 2022 | 25 | 0 |
| 2023 | 40 | 0 |
| 2024 | 40 | 0 |
| 2025 | 37 | 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? (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 |
|---|---|---|---|
| * | K974738 | Astra Tech Implant Dental SystemSummary page 1…3640) 3. Identification of Legally Marketed Device o Astra Tech Implants - Dental System ‘Prepable Abutment System’ K974738 o Nobel BioCare Ceradapt K number unknown o 3i ZiReal Post K991947 4. Device Descrip… | 1998 |
| * | K991947 | 3I Ceramic Abutment SystemSummary page 1…e Abutment System’ K974738 o Nobel BioCare Ceradapt K number unknown o 3i ZiReal Post K991947 4. Device Description This 51Ok describes an additional component for the Astra Tech Implants - Dental System, the… | 1999 |
| * | — | Nobel BioCare Ceradapt Named without a submission number |
What descends from it? (307)
See all 3075 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 8 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101005 (Astra Tech AB, 2011) has gone furthest, with 198 descendants of its own.
- 5 other devices also cite its predicate K974738.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Ceramic Abutment is intended for customized prosthetic treatment.
The Ceramic Abutment is used with dental implant supported restorations
in the anterior] canine, and premolar regions where high esthetic demands
are expressed
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023631: Astra Tech Dental Implants-Ceramic Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023631
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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