510(k) · Cleared
ClearedBiohorizons Laser-Lok Abutments for Nobel Biocare
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 Nov 4, 2011 as substantially equivalent to K100985 (BioHorizons Implant Systems, Inc., 2010) and 12 other predicates after a 361-day review. Its family tree reaches back 12 generations to 1996. 30 later devices descend from it.
- Decided
- Nov 4, 2011
- Review
- 361 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 12 generations to K960026 (1996). 177 ancestors in all, the oldest K820013 (1982). 30 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- This deviceK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · cites it directly · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · 2 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
- Descendant · 3 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 4 generations on · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 4 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- This deviceK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · cites it directly29descendants
- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 2 generations on26descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 3 generations on22descendants
- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 4 generations on8descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −2 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −1 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| 0 (this device) | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +1 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +2 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
| +3 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +4 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +4 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 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? (13)
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 |
|---|---|---|---|
| * | K100985 | Biohorizons Simple Solutions with Laser-LokSummary page 1…ant abutment Classification Number: Class 11 (21 CFR 872.3630) Predicate Devices 1. BioHorizons Simple Solutions with Laser-Lok, documented under 510(k) number K100985, concurrence date of September 9, 2010. 2. Astra Tech Atlantis Abutment in Zirconia for Nobel Replace Implant, documented und… | 2010 |
| * | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Summary page 1…0(k) number K100985, concurrence date of September 9, 2010. 2. Astra Tech Atlantis Abutment in Zirconia for Nobel Replace Implant, documented under 510(k) number K091920, concurrence date of September 28, 2009. 3. Pou Yu Biotechnology TOS Abutment for Nobel Biocare Replace, documented under 51 0(k)… | 2009 |
| * | K091026 | TDS Abutment for Nobel Biocare ReplaceSummary page 1…er 510(k) number K091920, concurrence date of September 28, 2009. 3. Pou Yu Biotechnology TOS Abutment for Nobel Biocare Replace, documented under 51 0(k) number K091 026, concurrence date of June 24, 2009. 4. Inclusive Dental Solutions Titanium Abutment Blanks, documented under 510(k) number K0… | 2009 |
| * | K083192 | Inclusive Titanium Abutment BlanksSummary page 1…cumented under 51 0(k) number K091 026, concurrence date of June 24, 2009. 4. Inclusive Dental Solutions Titanium Abutment Blanks, documented under 510(k) number K083192, concurrence date of March 4, 2009. 5. Zimmer Dental Ti Prepable Abutment, documented under 510(k) number K092403, concurrenc… | 2009 |
| * | K092403 | TI Prepable Abutment, Model 1618, 1619, 1620Summary page 1…ium Abutment Blanks, documented under 510(k) number K083192, concurrence date of March 4, 2009. 5. Zimmer Dental Ti Prepable Abutment, documented under 510(k) number K092403, concurrence date of October 30, 2009. 6. Altatec GmbH CAMLOG Implant System Abutments, documented under 510(k) number K0… | 2009 |
| * | K073553 | Camlog Implant System AbutmentsSummary page 1…nt, documented under 510(k) number K092403, concurrence date of October 30, 2009. 6. Altatec GmbH CAMLOG Implant System Abutments, documented under 510(k) number K073553, concurrence date of March 5, 2008. 7. Neoss Ltd. various Titanium Abutments, documented under 510(k) number K071838, concurr… | 2008 |
| * | K071838 | Neoss Various Titanium AbutmentsSummary page 1…System Abutments, documented under 510(k) number K073553, concurrence date of March 5, 2008. 7. Neoss Ltd. various Titanium Abutments, documented under 510(k) number K071838, concurrence date of October 19, 2007. 8. Altatec GmbH CAMLOG Implant System Modified Implants and Abutments, documented… | 2007 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 1…10(k) number K071838, concurrence date of October 19, 2007. 8. Altatec GmbH CAMLOG Implant System Modified Implants and Abutments, documented under 510(k) number K083496, concurrence date of January 30, 2009. - 9. Sirona Dental CAD/CAM System, documented under 501 (k) number K1 00152, concurrence… | 2009 |
| * | K100152 | Sirona Cad/Cam SystemSummary page 1…lants and Abutments, documented under 510(k) number K083496, concurrence date of January 30, 2009. - 9. Sirona Dental CAD/CAM System, documented under 501 (k) number K1 00152, concurrence date of October 22, 2010. 10. Thommen Medical AG SRI Titanium Base for CAD/CAM, documented under 510(k) number… | 2010 |
| * | K102804 | Spi Titanium Base for Cad/Cam Our reading of the summary gave K102604, FDA’s number for I-Logic Inreach System (Superdimension, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Thommen Medical AG SRI Titanium Base for CAD/CAM”. | 2011 |
| * | K050406 | Nobelspeedy ImplantsSummary page 1…e for CAD/CAM, documented under 510(k) number K1 02604, concurrence date of April 20, 2011. 11. Nobel Biocare NOBELSPEEDY TM Implants, documented under 510(k) number K050406, concurrence date of June 8, 2005. 12. Nobel Biocare Groovy Implants, documented under 510(k) number K050258, concurrence… | 2005 |
| * | K050258 | Groovy ImplantsSummary page 1…NOBELSPEEDY TM Implants, documented under 510(k) number K050406, concurrence date of June 8, 2005. 12. Nobel Biocare Groovy Implants, documented under 510(k) number K050258, concurrence date of April 19, 2005. 13. Nobel Biocare Endlosseous Implants, documented under 510(k) number K041661, conc… | 2005 |
| * | K041661 | Nobel Biocare Endosseous ImplantsSummary page 1…e Groovy Implants, documented under 510(k) number K050258, concurrence date of April 19, 2005. 13. Nobel Biocare Endlosseous Implants, documented under 510(k) number K041661, concurrence date of August 26, 2004. Device Description BioHorizons Laser-Lok Abutments for Nobel Biocare Tmare a series… | 2004 |
What descends from it? (30)
See all 301 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | 2013 | 29 |
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 15 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 24 of the 177 ancestors have a recall of any class.
- Of its descendants, K122295 (Core 3D Protech, S.L., 2013) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K100985.
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?
RioHorizons Laser-Lok Abutments for Nobel BiocareM are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Bidcare TM NobelReplace TM Straight GrooVyM, NobelReplace TM Tapered GroovyTM, NobelSpeedy Tm Replace TM , Replace TM Select Tapered and ReplaceT M Select Straight implants with 3.5mm (NP), 4.3mm…
Read the full statement (107 words)
RioHorizons Laser-Lok Abutments for Nobel BiocareM are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Bidcare TM NobelReplace TM Straight GrooVyM, NobelReplace TM Tapered GroovyTM, NobelSpeedy Tm Replace TM , Replace TM Select Tapered and ReplaceT M Select Straight implants with 3.5mm (NP), 4.3mm (RP) and 5.0mm (WP) platform diameter internal tri-channel connections. The abutment screw is intended to secure the abutment to the endosseous implant.
RioHorizons Laser-Lok Titanium Base Abutments for Nobel are intended to be used as straight abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103291
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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