# K120858: Implant Bar

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Dec 6, 2012 after 260 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: 9 generations back to K944964 (1995). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091848: Nobel/Procera Implant Bridge, Nobel Biocare AB (2009) Summary page 1.
- K101582: Cam Structsure Bars, Biomet 3i, Inc. (2010) Summary page 1.

## Indications for use
The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, 5.0mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.

Source page: https://510kreport.com/device/K120858
Methodology: https://510kreport.com/methodology