# K040079: M.L. Primer

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Sep 9, 2004 after 238 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and resin material, and used intra- or extra-orally. M.L. Primer is intended for use for the following: * Used when fabricating and repairing resin facing crowns. Used when repairing porcelain fused to facing crowns. * Used when fabricating and repairing denture base with metal plate, metal clasp or metal attachments. * Used for bonding metal restorations (inlays, onlays, crowns and bridges), metal splints, metal posts or metal core with dental adhesive resin cement or bonding/filling material, and used for their repair.

Source page: https://510kreport.com/device/K040079
Methodology: https://510kreport.com/methodology