# K053103: Interface

- Pathway: 510(k) (Abbreviated)
- Applicant: Apex Dental Materials, Inc.
- Decided: Feb 1, 2006 after 89 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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) Raw silane (3-(Trimethoxysilyl)propyl methacrylate, 98%) hydrolyzed with acetic acid: named in the summary without a submission number

## Indications for use
Interface TM is a ceramic primer/ conditioner, which allows the clinician to bond any type of ceramic (including newer high strength ceramic materials) to a tooth substrate. Interface IM when used in conjunction with a resin adhesive can be used for ceramic and ceramic to tooth repairs, as well as bonding ceramic inlays, onlays, crowns and veneers. Interface TM is to be used as a ceramic primer/ conditioner allowing bonding to ceramic, dentin and enamel all at the same time. With Interface, any dental ceramic can be repaired safely in the mouth without the use of dangerous hydrofluoric acid.

Source page: https://510kreport.com/device/K053103
Methodology: https://510kreport.com/methodology