# K091026: TDS Abutment for Nobel Biocare Replace

- Pathway: 510(k) (Traditional)
- Applicant: Pou YU Biotechnology Co., Ltd.
- Decided: Jun 24, 2009 after 75 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
No predicates in its family tree.
43 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K183518: Preat Abutments (2019), 22 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own

## Indications for use
TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants. Note: Highly angled abutments (i.e. 300) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.

Source page: https://510kreport.com/device/K091026
Methodology: https://510kreport.com/methodology