510(k) · Cleared
ClearedAstra Tech Implants-Dental System Fixture Osseospeed
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 Jun 10, 2003 as substantially equivalent to K931767 (Astra Tech, Inc., 1994) and 5 other predicates after a 179-day review. Its family tree reaches back 2 generations to 1994. 423 later devices descend from it.
- Decided
- Jun 10, 2003
- Review
- 179 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K931767 (1994). 6 ancestors in all. 423 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
- 1 generation backK980698 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 1998
- This deviceK024111 Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003
- Descendant · cites it directly · 357 of its ownK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- Descendant · 2 generations on · 337 of its ownK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008
- Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · cites it directly · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- Descendant · 2 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
Showing 5 of 423 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 423 · See all- K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007 · cites it directly357descendants
- K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc. · 2008 · 2 generations on337descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · cites it directly228descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 2 generations on222descendants
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 | K980698 | Astra Tech Implants - Dental System | Astra Tech, Inc. | 1998 | — |
| 0 (this device) | K024111 | Astra Tech Implants-Dental System Fixture Osseospeed | Astra Tech, Inc. | 2003 | — |
| +1 | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| +2 | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… | Astra Tech, Inc. | 2008 | — |
| +3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +1 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| +2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 1…Fixture OsseoSpeed is substantially similar in intended use, material, and design when compared to implants previously cleared via Astra Tech’s 51O(k) Numbers K931767, K990304, and K991053. The Fixture OsseoSpeed is considered substantially equivalent to components previously cleared under… | 1994 |
| * | K990304 | Modification to Astra Tech Implant - Dental SystemSummary page 1…OsseoSpeed is substantially similar in intended use, material, and design when compared to implants previously cleared via Astra Tech’s 51O(k) Numbers K931767, K990304, and K991053. The Fixture OsseoSpeed is considered substantially equivalent to components previously cleared under thes… | 1999 |
| * | K991053 | Astra Tech Implants - Dental System: New Fixtures (Micromacro)Summary page 1…substantially similar in intended use, material, and design when compared to implants previously cleared via Astra Tech’s 51O(k) Numbers K931767, K990304, and K991053. The Fixture OsseoSpeed is considered substantially equivalent to components previously cleared under these 51O(k)’s.… | 1999 |
| * | K002513 | Astra Tech Implants - Dental System | 2001 |
| Kept off the family tree | K012965 | Astra Tech fixtures Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K974738 | Astra Tech Implant Dental SystemSummary page 1…e abutments used with the Fixture OsseoSpeed are equivalent in intended purpose, material, and design compared with the standard abutments cleared via K931767, K974738, and K980698. 4. Device Description 1.3… | 1998 |
| * | K980698 | Astra Tech Implants - Dental SystemSummary page 1…sed with the Fixture OsseoSpeed are equivalent in intended purpose, material, and design compared with the standard abutments cleared via K931767, K974738, and K980698. 4. Device Description 1.3 === Page 2… | 1998 |
What descends from it? (423)
See all 4235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070833 | Atlantis Abutment for Astra Implant | 2007 | 357 |
| K060958 | Straumann Narrow Neck Implants | 2006 | 228 |
| K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | 2007 | 209 |
| K033171 | Nsi Hexed and Non-Hexed Implant System and Immediate Loading | 2004 | 32 |
| K083670 | Universal, Aesthetica, Natea, Natura | 2009 | 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 9 years and passes through 1 company; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K070833 (Atlantis Components, Inc., 2007) has gone furthest, with 357 descendants of its own.
- 12 other devices also cite its predicate K931767.
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?
Fixture OsseoSpeed and Fixture MicroMacro are intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using the one stage surgical protocol, immediate loading may be applied in the anterior mandibular region (between the mental foramina) if at least four implants are splinted with a bar, or other continuous suprastructure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024111: Astra Tech Implants-Dental System Fixture Osseospeed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024111
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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