M.L. PRIMER

• K Number: K040079
• Device Name: M.L. PRIMER
• Manufacturer: SHOFU DENTAL CORP.
• Date Cleared: 2004-09-09 ( 238 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

M.L. Primer is a metal-adhesive primer to promote adhesion between dental metal and dental resin materials intra- or extra-orally.

M.L. Primer is intended for use for the following:

• Used when fabricating and repairing resin facing crowns.
• Used when fabricating and repairing and repairing crowns.
• Used when repairing porcelain fused to facing crown.
• 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 on teeth used for their repair.
• Used for bonding metal restorations (inlays) with adhesive resin cement or used for their repair.

Device Description

Not Found

AI/ML Overview

There is no information in the provided text about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental product called M.L. Primer, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use but does not contain any performance data, study details, or acceptance criteria.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.