510(k) · Cleared
ClearedBiohorizons Plastic Temporary Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 14, 2006 as substantially equivalent to K050208 (Dentsply International, 2005) and 1 other predicate after a 103-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Feb 14, 2006
- Review
- 103 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894595 (1990). 23 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- 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 backK050208 Friadent EstheticapDentsply International · 2005
- This deviceK053099 Biohorizons Plastic Temporary AbutmentsBioHorizons Implant Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK122559 Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013
Most influential descendants
Showing 1 of 1 · See all- K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013 · cites it directly0descendants
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 | K050208 | Friadent Estheticap | Dentsply International | 2005 | — |
| 0 (this device) | K053099 | Biohorizons Plastic Temporary Abutments | BioHorizons Implant Systems, Inc. | 2006 | — |
| +1 | K122559 | Biodenta Dental Implant System - Abutments | Biodenta Swiss AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 30.7 · 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? (2)
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 |
|---|---|---|---|
| * | K050208 | Friadent EstheticapSummary page 1…umber: NHA, 872.3630 Predicate Devices 1. Friadent Esthicap, marketed by Dentsply International, York, Pennsylvania 17405, documented under 510(k) number K050208, concurrence date June 14, 2005. 2. Straumann RN synOcta Temporary Meso Abutment, marketed by Straumann Manufacturing, Andover… | 2005 |
| * | K051717 | RN Synocta Temporary Meso AbutmentSummary page 1…June 14, 2005. 2. Straumann RN synOcta Temporary Meso Abutment, marketed by Straumann Manufacturing, Andover, Massachusetts 01810 , documented under 51;0(k) number K051717, concurrence date July 7, 2005. Device Description BioHorizons Plastic Temporary Abutments are medical grade machined polyeth… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122559 | Biodenta Dental Implant System - Abutments | 2013 | 0 |
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 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K122559 (Biodenta Swiss AG, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050208.
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?
BioHorizons Plastic Temporary Abutments are intended for short-term use of 30 days or less as a base for cemented or screw-retained crown and bridge restoration of dental implants, while esthetically contouring soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053099: Biohorizons Plastic Temporary Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053099
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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