# K100985: Biohorizons Simple Solutions with Laser-Lok

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Sep 9, 2010 after 153 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: 11 generations back to K960026 (1996). 36 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073282: Biohorizons Single-Stage Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 1.
- K073268: Biohorizons Internal Implant System, BioHorizons Implant Systems, Inc. (2008) Summary page 2.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 1.
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 1.
- K093321: Biohorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. (2010) Summary page 1.

## Most influential descendants
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own
- 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

## Indications for use
BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prosthesis: The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

Source page: https://510kreport.com/device/K100985
Methodology: https://510kreport.com/methodology