# K984287: Provisional Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Mar 1, 1999 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Dentatus’ “MTI Implant”: named in the summary without a submission number
- (no number) Sendax’s “Mini Dental Implant”: named in the summary without a submission number

## Indications for use
The intended use for this device is to serve as temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.

Source page: https://510kreport.com/device/K984287
Methodology: https://510kreport.com/methodology