# K991947: 3I Ceramic Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 29, 1999 after 112 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
No predicates in its family tree.
565 later devices descend from it; 3 cite it directly.
0 of 566 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nobel Biocare “CerAdapt” abutment: named in the summary without a submission number

## Most influential descendants
- 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
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own
- K023631: Astra Tech Dental Implants-Ceramic Abutments (2002), 307 descendants of its own

## Indications for use
Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant’s coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.

Source page: https://510kreport.com/device/K991947
Methodology: https://510kreport.com/methodology