# K993129: Ucla/Universal Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Diamodent
- Decided: Mar 28, 2000 after 190 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101068: Accufit Dental Implant Abutments & Screws (2010), 0 descendants of its own

## Indications for use
Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw. Impression Posts are used to register the location and position of the implants in mouth. Implant Analogs are replicas of the implants and are mounted in stone model. Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement. Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement. Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting. All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Brdnemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.

Source page: https://510kreport.com/device/K993129
Methodology: https://510kreport.com/methodology