# K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Nov 4, 2011 after 361 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K960026 (1996). 177 ancestors in all.
30 later devices descend from it; 1 cites it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100985: Biohorizons Simple Solutions with Laser-Lok, BioHorizons Implant Systems, Inc. (2010) Summary page 1.
- K091920: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants, Atlantis Gemini + Abutment for Nobel, Astra Tech, Inc. (2009) Summary page 1.
- K091026: TDS Abutment for Nobel Biocare Replace, Pou YU Biotechnology Co., Ltd. (2009) Summary page 1.
- K083192: Inclusive Titanium Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 1.
- K092403: TI Prepable Abutment, Model 1618, 1619, 1620, Zimmer Dental, Inc. (2009) Summary page 1.
- K073553: Camlog Implant System Abutments, Altatec GmbH (2008) Summary page 1.
- K071838: Neoss Various Titanium Abutments, Neoss, Ltd. (2007) Summary page 1.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 1.
- K100152: Sirona Cad/Cam System, Sirona Dental Systems GmbH (2010) Summary page 1.
- K102804: Spi Titanium Base for Cad/Cam, Thommen Medical AG (2011). 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”.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 1.
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 1.
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own
- K151621: BioHorizons CAD/CAM Abutments (2016), 26 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103291
Methodology: https://510kreport.com/methodology