510(k) · Cleared
ClearedAllied Biocompat Abutment for Nobel Replace Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allied Dental Solutions · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 14, 2016 as substantially equivalent to K053654 (Atlantis Components, Inc., 2006) after a 167-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Mar 14, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894595 (1990). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 1 generation backK053654 Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc. · 2006
- This deviceK152845 Allied Biocompat Abutment for Nobel Replace InterfaceAllied Dental Solutions · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −1 | K053654 | Atlantis Abutment for Nobel Replace Interface | Atlantis Components, Inc. | 2006 | — |
| 0 (this device) | K152845 | Allied Biocompat Abutment for Nobel Replace Interface | Allied Dental Solutions | 2016 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K053654 | Atlantis Abutment for Nobel Replace InterfaceSummary page 5…ct meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Predicate Device: Primary Predicate Atlantis Abutments K053654 and Reference Predicates Atlantis Abutments K981858, Replace TiUnite Endosseous Implant K023113, and Replace HA Coated Implant K0… | 2006 |
| † | K981858 | Atlantis Abutment and Atlantis Abutment Screw | 1999 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 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 26 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K053654.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Allied Biocompat 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 prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant. Allied Biocompat Abutments are…
Read the full statement (108 words)
The Allied Biocompat 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 prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
Allied Biocompat Abutments are compatible with the following
Implant Manufacturer: Nobel Biocare
Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered and Select Tapered One Stage
Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152845: Allied Biocompat Abutment for Nobel Replace Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152845
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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