510(k) · Cleared
ClearedAtlantis Abutment for Astra Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlantis Components, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 22, 2007 as substantially equivalent to K062069 (Atlantis Components, Inc., 2007) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1993. 357 later devices descend from it.
- Decided
- Jun 22, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K925765 (1993). 19 ancestors in all. 357 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 3 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 2 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 1 generation backK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
- This deviceK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
- 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 · 209 of its ownK071946 Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007
- Descendant · 2 generations on · 202 of its ownK110356 Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc. · 2011
- Descendant · 2 generations on · 200 of its ownK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
Showing 5 of 357 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 357 · 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
- K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007 · cites it directly209descendants
- K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc. · 2011 · 2 generations on202descendants
- K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · 2 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −3 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −2 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −1 | K062069 | Atlantis Abutment for 3I Micromini Implant | Atlantis Components, Inc. | 2007 | — |
| 0 (this device) | K070833 | Atlantis Abutment for Astra Implant | Atlantis Components, Inc. | 2007 | — |
| +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 | K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | Atlantis Components, Inc. | 2007 | — |
| +2 | K110356 | Atlantis Crown Abutment, Atlantis Gemini +(TM) Abutment | Astra Tech, Inc. | 2011 | — |
| +2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 19 | 0 |
| 2016 | 19 | 0 |
| 2017 | 18 | 0 |
| 2018 | 18 | 0 |
| 2019 | 17 | 0 |
| 2020 | 27 | 0 |
| 2021 | 27 | 0 |
| 2022 | 29 | 0 |
| 2023 | 39 | 0 |
| 2024 | 50 | 0 |
| 2025 | 39 | 0 |
| 2026 | 20 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K062069 | Atlantis Abutment for 3I Micromini ImplantSummary page 1…510(k) Number Atlantis Components -Atlantis Abutment for 3i MicroMini K062069 Inc. -Astra Fixture K053384 Astra Tech Inc MicroThreadTMOsseoSpeedTM… | 2007 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 1…Number Atlantis Components -Atlantis Abutment for 3i MicroMini K062069 Inc. -Astra Fixture K053384 Astra Tech Inc MicroThreadTMOsseoSpeedTM K0241 11 Astra Tech inc. -Astra Tech Implants-Dent… | 2006 |
| * | K024111 | Astra Tech Implants-Dental System Fixture OsseospeedSummary page 1…for 3i MicroMini K062069 Inc. -Astra Fixture K053384 Astra Tech Inc MicroThreadTMOsseoSpeedTM K0241 11 Astra Tech inc. -Astra Tech Implants-Dental System Fixture MicroMacro 4. Descriptio… | 2003 |
| * | — | Astra Tech Implants-Dental System Fixture MicroMacro Named without a submission number |
What descends from it? (357)
See all 3574 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 |
| K071946 | Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants | 2007 | 209 |
| K101005 | Astra Tech Implant System, New Component | 2011 | 198 |
| K072241 | Primaconnex Cad/Cam Abutment System | 2007 | 7 |
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 14 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K081666 (Astra Tech, Inc., 2008) has gone furthest, with 337 descendants of its own.
- 1 other device also cites its predicate K062069.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis Abutment for Astra Implant is compatible with…
Read the full statement (148 words)
The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeedTM 3.5(S) mm, 4.0(S) mm Internal Hex Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070833: Atlantis Abutment for Astra Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070833
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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