# K192108: Panthera Dental Milled Bars

- Pathway: 510(k) (Abbreviated)
- Applicant: Panthera Dental, Inc.
- Decided: Apr 8, 2020 after 247 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: 8 generations back to K944964 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173466: Panthera Dental Milled Bars, Panthera Dental, Inc. (2018) Summary page 4.

## Indications for use
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained. The Panthera Dental Milled Bars are indicated for compatibility with: » NobelActive: NP @3.5; RP 04.3 / @5.0; WP 05.5 » NobelParallel CC: NP ©03.75; RP @4.3 / @5.0; WP @5.5 * NobelReplace: NP 033.5; RP 04.0 / ¥4.3 / ©5.0; WP 05.0; 6 06.0 * NobelSpeedy: RP ©4.0 / ©5.0; WP ©5.0 / ©6.0 » Branemark: NP ?3.3; RP ©@3.75 / @4.0; WP ©@5.0

Source page: https://510kreport.com/device/K192108
Methodology: https://510kreport.com/methodology