510(k) · Cleared
ClearedAstra Tech Implants - Dental System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 19, 1998 as substantially equivalent to K931767 (Astra Tech, Inc., 1994) after a 24-day review. Its family tree reaches back 1 generation to 1994. 424 later devices descend from it.
- Decided
- Mar 19, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931767 (1994). 424 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- This deviceK980698 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 1998
- Descendant · cites it directly · 423 of its ownK024111 Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003
- Descendant · 2 generations on · 357 of its ownK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- Descendant · 3 generations on · 337 of its ownK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008
- Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · 2 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
Showing 5 of 424 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 424 · See all- K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003 · cites it directly423descendants
- K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007 · 2 generations on357descendants
- K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc. · 2008 · 3 generations on337descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 2 generations on228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931767 | Astra Tech Implants-Dental System | Astra Tech, Inc. | 1994 | — |
| 0 (this device) | K980698 | Astra Tech Implants - Dental System | Astra Tech, Inc. | 1998 | — |
| +1 | K024111 | Astra Tech Implants-Dental System Fixture Osseospeed | Astra Tech, Inc. | 2003 | — |
| +2 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| +3 | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… | Astra Tech, Inc. | 2008 | — |
| +4 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 11 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 9 | 0 |
| 2015 | 21 | 0 |
| 2016 | 21 | 0 |
| 2017 | 21 | 0 |
| 2018 | 23 | 0 |
| 2019 | 21 | 0 |
| 2020 | 32 | 0 |
| 2021 | 32 | 0 |
| 2022 | 31 | 0 |
| 2023 | 44 | 0 |
| 2024 | 54 | 0 |
| 2025 | 40 | 0 |
| 2026 | 23 | 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? (2)
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 |
|---|---|---|---|
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 1…IONAL COMPONENTS for cement retained crown and bridge constructions Classification Name Endosseous Implant Predicate Devices Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST) STERI-OSS REPLACE Direct Abutment 5.0 Series Description of Device an… | 1994 |
| * | — | STERI-OSS REPLACE Direct Abutment 5.0 Series Named without a submission number |
What descends from it? (424)
See all 4242 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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For use in cement retained crown and bridge construction. Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. Used…
Read the full statement (115 words)
For use in cement retained crown and bridge construction.
Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
Attachment element for connection/fixation of abutments to fixtures
Attachment element for connection/fixation of abutments to fixtures
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/K980698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980698: Astra Tech Implants - Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980698
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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