MPa Max adhesive— 510(k) K262252
Substantially EquivalentDen-Mat Holdings, LLC
FDA 510(k) clearance K262252 for MPa Max adhesive, Substantially Equivalent on 2026-09-24. Applicant: Den-Mat Holdings, LLC. Device class: 2.
Summary
MPa Max adhesive is a dental bonding agent from Den-Mat Holdings, LLC, filed under KLE, resin tooth bonding agents. The record doesn't describe its chemistry or bonding protocol.
Class II, 21 CFR 872.3200. The Dental panel reviewed it as a Traditional 510(k).
Den-Mat filed from Lompoc, California. Review took 84 days (July 2 to September 24, 2026).
Clearance details
- Applicant
- Den-Mat Holdings, LLC
- Product code
- Product code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lompoc, CA, US
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