510(k) · Cleared
ClearedFixature Microthread Osseospeed, a Component of the Astra Tech Implant 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 24, 2006 after a 109-day review. The FDA summary names its predicate without a number. 528 later devices descend from it.
- Decided
- Mar 24, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
528 later devices descend from it, 12 citing it directly.
- This deviceK053384 Fixature Microthread Osseospeed, a Component of the Astra Tech…Astra Tech, Inc. · 2006
- 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 · 214 of its ownK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · cites it directly · 209 of its ownK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
Showing 5 of 528 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 528 · 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
- K101732Astra Tech Implant SystemAstra Tech AB · 2011 · cites it directly214descendants
- K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007 · cites it directly209descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System | Astra Tech, Inc. | 2006 | — |
| +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 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| +1 | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 18 | 0 |
| 2015 | 27 | 0 |
| 2016 | 28 | 0 |
| 2017 | 31 | 0 |
| 2018 | 26 | 0 |
| 2019 | 24 | 0 |
| 2020 | 44 | 0 |
| 2021 | 40 | 0 |
| 2022 | 38 | 0 |
| 2023 | 58 | 0 |
| 2024 | 60 | 0 |
| 2025 | 47 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | — | Fixture OsseoSpeed Named without a submission number | |
| * | — | TiUnite implant Named without a submission number |
What descends from it? (528)
See all 52812 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 |
| K101732 | Astra Tech Implant System | 2011 | 214 |
| K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | 2007 | 209 |
| K111287 | Astra Tech Implant System | 2011 | 201 |
| K101207 | Neodent Implant System | 2010 | 181 |
| K101945 | Neodent Implant System | 2011 | 180 |
| K080744 | HG II Fixture System | 2008 | 112 |
| K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems | 2006 | 66 |
| K061478 | Procera Titanium Abutment for Astratech and Camlog Implant Systems | 2006 | 33 |
| K070184 | Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing Abutment | 2008 | 1 |
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, K070833 (Atlantis Components, Inc., 2007) has gone furthest, with 357 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.
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 MicroThreadTM OsseoSpeed TM is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. 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…
Read the full statement (166 words)
Fixture MicroThreadTM OsseoSpeed TM is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. 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 after implantation where immediate implant stability may be obtained.
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. Fixture MicroThread OsseoSpeed 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/K053384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053384: Fixature Microthread Osseospeed, a Component of the 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/K053384
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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