# K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 18, 2004 after 14 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: 6 generations back to K944964 (1995). 59 ancestors in all.
327 later devices descend from it; 4 cite it directly.
0 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041236: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052, Nobel Biocare AB (2004) Summary page 1.
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 1.
- K954512: Restore Self Tapping Dental Implant System, Lifecore Biomedical, Inc. (1996) Summary page 1.
- K011038: Taper-Lock Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.
- K981516: Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA Coated , Refer to Table 1 in Sub, Sterngold/Implamed (1998) Summary page 1.

## Most influential descendants
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar (2010), 167 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own

## Indications for use
The Procera® Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. In addition to the Branemark implant, the bridge's hexagon connector interface fits the external hexagon of the following endosseous implants: * 3i® 3.75 * Lifecore® Biomedical Restore 3.75 * Zimmer® Dental Taper-lock 4.0 * Sterngold Implamed® 3.75

Source page: https://510kreport.com/device/K043042
Methodology: https://510kreport.com/methodology