510(k) · Cleared
ClearedAtlantis Abutment for Nobel Replace Interface
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 Jul 31, 2006 as substantially equivalent to K981858 (Atlantis Components, Inc., 1999) and 2 other predicates after a 213-day review. Its family tree reaches back 4 generations to 1990. 12 later devices descend from it.
- Decided
- Jul 31, 2006
- Review
- 213 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894595 (1990). 18 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 1 generation backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- This deviceK053654 Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK110565 Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc. · 2011
- Descendant · 2 generations on · 9 of its ownK112730 Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i · 2012 · Recalled
- Descendant · 3 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · 4 generations on · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK210362 s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K110565Abutments for Competitive Implant Systems-Nobel ReplaceBiomet 3i, Inc. · 2011 · cites it directly10descendants
- K112730Abutment for Competitive Implant Straumann Bone Level ConnectionBiomet 3i · 2012 · 2 generations on9descendants
- K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 3 generations on7descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 4 generations on1descendant
- K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −1 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| 0 (this device) | K053654 | Atlantis Abutment for Nobel Replace Interface | Atlantis Components, Inc. | 2006 | — |
| +1 | K110565 | Abutments for Competitive Implant Systems-Nobel Replace | Biomet 3i, Inc. | 2011 | — |
| +2 | K112730 | Abutment for Competitive Implant Straumann Bone Level Connection | Biomet 3i | 2012 | 2 |
| +3 | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +4 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
| +4 | K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 2…e AtlantisTM Abutments for Nobel Replace Interface are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace TiUnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively,… | 1999 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 2…al, design and performance to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace TiUnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively, DEPARTMENT OF HEALTH & HUMAN SERVICES Public… | 2002 |
| * | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Summary page 2…nd performance to the Atlantis Abutments cleared under K981858 and Nobel Biocare Replace TiUnite Implants and Replace HA Coated Implants cleared under 510(k) K023113 and K020646 respectively, DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Serv… | 2002 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K110565 (Biomet 3i, Inc., 2011) has gone furthest, with 10 descendants of its own.
- 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.
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. This device is compatible with the following manufacturers'…
Read the full statement (159 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.
This device is compatible with the following manufacturers' implant systems: Nobel
Biocare Replace Select Straight, Replace Select Straight One Stage, Replace Select
Tapered and Replace Select Tapered One Stage.
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/K053654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053654: Atlantis Abutment for Nobel Replace Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053654
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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