510(k) · Cleared
ClearedAtlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 10, 2011 as substantially equivalent to K022425 (Altatec Biotechnologies N.A., Inc., 2002) and 2 other predicates after a 98-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.
- Decided
- Jun 10, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000065 (2000). 3 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000065 Camlog Cylinder Implant SystemAltatec Biotechnologies · 2000
- This deviceK110640 Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later…Astra Tech, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK132881 Z5CZ-Systems AG · 2014
- Descendant · 2 generations on · 4 of its ownK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK190243 Z5-BLZ-Systems AG · 2020
- Descendant · 3 generations on · 1 of its ownK181953 SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019
- Descendant · 3 generations on · 1 of its ownK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132881Z5CZ-Systems AG · 2014 · cites it directly8descendants
- K172668W Zirconia ImplantsTav Medical, Ltd. · 2018 · 2 generations on4descendants
- K190243Z5-BLZ-Systems AG · 2020 · 2 generations on2descendants
- K181953SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019 · 3 generations on1descendant
- K192053W Zirconia ImplantsTav Medical, Ltd. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000065 | Camlog Cylinder Implant System | Altatec Biotechnologies | 2000 | — |
| 0 (this device) | K110640 | Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment | Astra Tech, Inc. | 2011 | — |
| +1 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| +2 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| +2 | K190243 | Z5-BL | Z-Systems AG | 2020 | — |
| +3 | K181953 | SDS1.2 dental implant | Sds Swiss Dental Solutions AG | 2019 | — |
| +3 | K192053 | W Zirconia Implants | Tav Medical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2023 | 1 | 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 30.6 · 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? (3)
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 |
|---|---|---|---|
| * | K022425 | ScrewlineSummary page 3…n for Substantial Equivalence: The AtlantisTh Abutment for Camlog Implant is substantially equivalent to Altatec' s predicate devices: : ScrewLine Implant cleared under K022425, Cylinder Implant cleared under K000065 and Rootform Implant cleared under KOOOIOO0, based on noted similarities in indication, m… | 2002 |
| * | K000065 | Camlog Cylinder Implant SystemSummary page 3…ntisTh Abutment for Camlog Implant is substantially equivalent to Altatec' s predicate devices: : ScrewLine Implant cleared under K022425, Cylinder Implant cleared under K000065 and Rootform Implant cleared under KOOOIOO0, based on noted similarities in indication, manufacturing material, generated design… | 2000 |
| * | K000100 | Camlog Rootform Implant System | 2000 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132881 | Z5C | 2014 | 8 |
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?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 with 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 cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers'…
Read the full statement (166 words)
The Atlantis Abutment is intended for use with 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 cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Canilog 3.3mm, 3.8mm, 4.3mm, 5.0mm. and 6.0mmn Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
The zirconia abutments are compatible with the Camlog 3.Smrn, 4.3mm, 5.0mmn and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 on small diameter implants are intended for the anterior region only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110640: Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110640
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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