# K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Oct 20, 2004 after 22 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). 38 ancestors in all.
441 later devices descend from it; 10 cite it directly.
0 of 480 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031719: Esthetic Zirconia Abutment, Nobel Biocare AB (2003) Summary page 1.
- K974150: Procera Preparable Abutment System, Nobel Biocare Uas, Inc. (1998) Summary page 1.
- K913255: Ceramic (TM) Abutment, Ceramic Core Corp. (1994) 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.
- 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.

## Cited in the summary but kept off the family tree
- K001038: Taperlock Dental Implant System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia (2005), 261 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K093780: Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 200 descendants of its own
- K101004: Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment (2010), 199 descendants of its own

## Indications for use
Nobel Biocare's Procera® Abutment Brinemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the BrAnemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants: - 3® 3.75 - Lifecore® Biomedical Restore 3.75 - Zimmere Dental Taperlock 4.0 - Stemgold Implamed® 3.75

Source page: https://510kreport.com/device/K042658
Methodology: https://510kreport.com/methodology