# K041661: Nobel Biocare Endosseous Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Aug 26, 2004 after 69 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: 4 generations back to K894595 (1990). 17 ancestors in all.
622 later devices descend from it; 8 cite it directly.
0 of 640 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022424: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Most influential descendants
- K050705: Tiunite Implants (2005), 532 descendants of its own
- K050258: Groovy Implants (2005), 511 descendants of its own
- K061003: SFB & CFB Implants (2006), 507 descendants of its own
- K071370: Nobelactive Internal Connection Implant (2007), 414 descendants of its own
- K062749: SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model 33701, CFB 15 Esthetic Abutment 2MM (2006), 327 descendants of its own

## Indications for use
Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 450 . When used with angulations between 300 and 450, the following applies: • the tilted implants must be splinted • a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

Source page: https://510kreport.com/device/K041661
Methodology: https://510kreport.com/methodology