# K955281: Endosseous Dental Implant & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: The Straumann Co.
- Decided: Mar 15, 1996 after 120 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: 1 generation back to K894595 (1990). 4 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894595: Bonefit R Screw Implants, Institut Straumann AG (1990) Summary page 1.
- K920768: Hollow Screw Implants 6MM, 14MM, 16MM, The Straumann Co. (1992) Summary page 1.
- K926501: Branemark System (R) - 5.5MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 1.
- K944068: Restore Self Tapping Dental Implant Syst (5, 5.5,6MM), Lifecore Biomedical, Inc. (1995) Summary page 1.
- (no number) Implant Innovations, Inc. wide diameter implants: named in the summary without a submission number

## Most influential descendants
- K061169: Endosseous Dental Implant (2006), 24 descendants of its own
- K070841: Endosseous Dental Implant System (2007), 21 descendants of its own
- K070905: Endosseous Dental Implant System (2007), 17 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K163060: Deep Conical (DC) Implants and Accessories (2017), 7 descendants of its own

## Indications for use
The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is intended for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

Source page: https://510kreport.com/device/K955281
Methodology: https://510kreport.com/methodology