510(k) · Cleared
ClearedOsseospeed TM Profile 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 17, 2008 after a 238-day review. The FDA summary names no predicate by number. 67 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 238 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 6 citing it directly.
- This deviceK080156 Osseospeed TM Profile SystemAstra Tech AB · 2008
- Descendant · cites it directly · 34 of its ownK093643 Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010
- Descendant · 2 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · cites it directly · 19 of its ownK103759 Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc. · 2011
- Descendant · cites it directly · 18 of its ownK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- Descendant · 3 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB · 2010 · cites it directly34descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 2 generations on25descendants
- K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc. · 2011 · cites it directly19descendants
- K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013 · cites it directly18descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080156 | Osseospeed TM Profile System | Astra Tech AB | 2008 | — |
| +1 | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | Nobel Biocare AB | 2010 | — |
| +2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +1 | K103759 | Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant | Astra Tech, Inc. | 2011 | — |
| +1 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| +3 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant Systems | 2010 | 34 |
| K103759 | Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant | 2011 | 19 |
| K130999 | Osseospeed Profile EV | 2013 | 18 |
| K112795 | Paltop Dental Implant System | 2012 | 11 |
| K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 | 5 |
| K103280 | Bhdental Implant System | 2011 | 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?
- Of its descendants, K093643 (Nobel Biocare AB, 2010) has gone furthest, with 34 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. 2008, 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?
OsseoSpeedTM Profile 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…
Read the full statement (158 words)
OsseoSpeedTM Profile 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 fluoride-modified 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. OsseoSpeed Profile 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080156: Osseospeed TM Profile System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080156
Report an extraction error
Are you the manufacturer?
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