# K962403: Noblepharma Wide Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Sep 6, 1996 after 77 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944964 (1995). 10 ancestors in all.
549 later devices descend from it; 2 cite it directly.
0 of 560 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925770: Branemark System Drills and Countersinks, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925768: Branemark System Screw Tap, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925774: Branemark System Hand Instrument, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925779: Branemark System Titanium Healing Abutments, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925771: Branemark System Titanium Cover Screws, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925775: Branemark System Machine Inst. Acc. to Drilling EQ, Nobelpharma USA, Inc. (1993) Summary page 1.
- K961728: Miruscone Abutment System, Nobelpharma USA, Inc. (1996). Cleared while this submission was under review Summary page 1.
- K961737: Cera One Abutment System, Nobelpharma USA, Inc. (1996). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K971706: Tiadapt Abutment System (1997), 545 descendants of its own
- K974150: Procera Preparable Abutment System (1998), 543 descendants of its own
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 327 descendants of its own

## Indications for use
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

Source page: https://510kreport.com/device/K962403
Methodology: https://510kreport.com/methodology