# K121117: NDX Abutments

- Pathway: 510(k) (Traditional)
- Applicant: National Dentex Corp
- Decided: Dec 14, 2012 after 246 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). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103339: TDS Abutment for Friadent Xive, Pou YU Biotechnology Co., Ltd. (2011) Summary page 3.
- K091392: TDS Titanium Abutment for Nobel Biocare Branemark, Pou YU Biotechnology Co., Ltd. (2009) Summary page 3.
- K091026: TDS Abutment for Nobel Biocare Replace, Pou YU Biotechnology Co., Ltd. (2009) Summary page 3.
- K081460: TDS Abutment, Pou YU Biotechnology Co., Ltd. (2008) Summary page 3.

## Indications for use
NDX Custom Abutments are 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. NDX Abutment for Nobel Biocare Brilnemark is compatible with the following implant systems: Nobel Biocare: Brilnemark System® Mk III Groovy Brinemark System®@ Mk Ill Shorty Brilnemark System®g Zygoma NobelSpeedy Groovy NobelSpeedy Shorty NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Biocare: Nobel Replace® Select Straight Nobel Replace Select Straight One Stage Replace Select Tapered Replace Select Tapered One Stage Nobel Replace Straight Nobel Replace Tapered Nobel Replace Straight Groovy Nobel Replace Tapered Groovy for the 3.5 mm (NP) 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants NDX Abutment for Nobel Active is compatible with the following implant system: Nobel Biocare: NobelActive Implant NDX Abutment for 3i External Hex is compatible with the following implant systems: 3i: NanoTite External Hex Connection Implants Full OSSEOTITE External Hex Connection Implants OSSEOTITE External Hex Connection Implant NDX Abutment for 3i Certain Internal is compatible with the following implant system: 3i: Certain Internal Connection

Source page: https://510kreport.com/device/K121117
Methodology: https://510kreport.com/methodology