# K100633: Infinitas Mini-Implant Model: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

- Pathway: 510(k) (Special)
- Applicant: D B Orthodontics, Ltd.
- Decided: Apr 1, 2010 after 27 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Temporary anchorage point for the attachment of Orthodontic appliances

Source page: https://510kreport.com/device/K100633
Methodology: https://510kreport.com/methodology