# K192522: TSV BellaTek Express and BellaTek Flex Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, LLC
- Decided: Dec 9, 2019 after 87 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: 17 generations back to K960026 (1996). 318 ancestors in all.
No later device cites it as a predicate yet.
0 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183138: Certain BellaTek Express and BellaTek Flex Abutments, Biomet 3i (2019) Summary page 4.

## Indications for use
TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

Source page: https://510kreport.com/device/K192522
Methodology: https://510kreport.com/methodology