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 Sep 22, 2009 after a 148-day review. The FDA summary names no predicate by number. 228 later devices descend from it.
- Decided
- Sep 22, 2009
- Review
- 148 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
228 later devices descend from it, 6 citing it directly.
- This deviceK091239 Astra Tech Implant SystemAstra Tech AB · 2009
- Descendant · cites it directly · 214 of its ownK101732 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 · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 228 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 228 · See all- K101732Astra Tech Implant SystemAstra Tech AB · 2011 · cites it directly214descendants
- 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 · 2 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091239 | Astra Tech Implant System | Astra Tech AB | 2009 | — |
| +1 | 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 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 0 |
| 2019 | 12 | 0 |
| 2020 | 17 | 0 |
| 2021 | 15 | 0 |
| 2022 | 22 | 0 |
| 2023 | 27 | 0 |
| 2024 | 31 | 0 |
| 2025 | 37 | 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?
The FDA summary names no predicate by number.
What descends from it? (228)
See all 2286 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, K101732 (Astra Tech AB, 2011) has gone furthest, with 214 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied…
Read the full statement (201 words)
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type. IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed Tm 4.OS - 6 mm implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091239 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091239: Astra Tech Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091239
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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