# K034022: Ucla and Cement-on Abutments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Diamodent
- Decided: Jan 30, 2004 after 32 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
The UCLA Abutments and Cement-On Abutments are designed for use with commercially available dental implant systems. These abutments are straight abutments and are NOT angled abutments. The abutments will scat directly on implants and are sub-structure of prosthesis. Some abutments are used as pattern in dental laboratory to make prosthesis, such as UCLA Plastic Cylinders. All abutments have been designed specifically to be compatible and to be used with each of the following implant systems and sizes (for engineering drawings please refer to Attachment GG). IMPLANT COMPANIES IMPLANT SYSTEMS IMPLANT SIZE (mm) Nobel Biocare NobelPertect 3.5, 4.3 & 5.0amm Replace Select 3.5, 4.3, 5.0 & 6.0mm Straumann ITI 3.5mm Shoulder Diameter Narrow Neck Solid Screw ITI 4.8mm Shoulder Diameter Solid Screw ITI 6.5mm Shoulder Diameter Wide Neck Solid Screw Dentsply/ Friadent Frialit-2 3.4, 3.8, 4.5, 5.5 & 6.5mm XiVE 3.4, 3.8, 4.5 & 5.5mm 3j Osseotite Certain 4.0, 5.0 & 6.0mm

Source page: https://510kreport.com/device/K034022
Methodology: https://510kreport.com/methodology