510(k) · Cleared
ClearedOsseospeed Narrow
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 Apr 30, 2008 after a 77-day review. The FDA summary names no predicate by number. 390 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
390 later devices descend from it, 10 citing it directly.
- This deviceK080396 Osseospeed NarrowAstra Tech AB · 2008
- Descendant · cites it directly · 337 of its ownK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008
- Descendant · 2 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · cites it directly · 198 of its ownK101005 Astra Tech Implant System, New ComponentAstra Tech AB · 2011
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 3 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 390 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 390 · See all- K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc. · 2008 · cites it directly337descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 2 generations on240descendants
- K101005Astra Tech Implant System, New ComponentAstra Tech AB · 2011 · cites it directly198descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 3 generations on165descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080396 | Osseospeed Narrow | Astra Tech AB | 2008 | — |
| +1 | K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… | Astra Tech, Inc. | 2008 | — |
| +2 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +1 | K101005 | Astra Tech Implant System, New Component | Astra Tech AB | 2011 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 19 | 0 |
| 2016 | 23 | 0 |
| 2017 | 23 | 0 |
| 2018 | 21 | 0 |
| 2019 | 20 | 0 |
| 2020 | 29 | 0 |
| 2021 | 33 | 0 |
| 2022 | 33 | 0 |
| 2023 | 43 | 0 |
| 2024 | 53 | 0 |
| 2025 | 40 | 0 |
| 2026 | 21 | 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? (390)
See all 39010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081666 | Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants | 2008 | 337 |
| K101005 | Astra Tech Implant System, New Component | 2011 | 198 |
| K120414 | Osseospeed Plus | 2012 | 196 |
| K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 | 103 |
| K092555 | Uno Narrow Implant | 2010 | 36 |
| K130462 | Paltop Narrow Implant, Paltop Short Implant | 2013 | 8 |
| K092112 | Bti Dental Implant Tiny 2.5-3.0 | 2009 | 6 |
| K083544 | Kat Implant System | 2009 | 4 |
| K140293 | Touareg NP Closefit Dental Implants System | 2014 | 2 |
| K112875 | Blue Sky Bio Dental Taper Hex Implant Systems | 2012 | 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, K081666 (Astra Tech, Inc., 2008) has gone furthest, with 337 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 Narrow 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 (178 words)
OsseoSpeedTM Narrow 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 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 Narrow 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/K080396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080396: Osseospeed Narrow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080396
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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