510(k) · Cleared
ClearedAtlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment
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 Feb 28, 2007 as substantially equivalent to K981858 (Atlantis Components, Inc., 1999) and 2 other predicates after a 211-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Feb 28, 2007
- Review
- 211 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K925765 (1993). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 2 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 1 generation backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- This deviceK062197 Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+…Atlantis Components, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −2 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −1 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| 0 (this device) | K062197 | Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment | Atlantis Components, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K981858 | Atlantis Abutment and Atlantis Abutment ScrewSummary page 1…510(k) Number Atlantis Components Atlantis Abutment and Abutment K981858 Inc. Screw Atlantis Components Atlantis Abutment for 3i Certain K051011 Inc.… | 1999 |
| * | K051011 | Endosseous Dental Implant AbutmentSummary page 1…omponents Atlantis Abutment and Abutment K981858 Inc. Screw Atlantis Components Atlantis Abutment for 3i Certain K051011 Inc. Implant 3iImplant Innovations Osseotite NTDentalImplants K014235 4. Descripti… | 2005 |
| * | K014235 | Osseotite NT Dental Implants & AccessoriesSummary page 1…omponents Atlantis Abutment for 3i Certain K051011 Inc. Implant 3iImplant Innovations Osseotite NTDentalImplants K014235 4. Descriptionof theDevice The devices covered in this submission are abutments which are placed into the dental implant to… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 ancestors has a recall.
- 9 other devices also cite its predicate K981858.
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 31 Certain MicroMini Implant is…
Read the full statement (155 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 31 Certain MicroMini Implant is compatible with 31 Osseotite: NT® Certain and Parallel Walled Implants both with 3.25 mm diameters.
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. Hlighly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended tbr the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant fixture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062197: Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062197
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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