MEDIUMRegulatoryTier 1
FDA 510(k) K262252: MPa Max adhesive
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dentists and practice owners who use bonding agents now have a new FDA-cleared option (MPa Max adhesive, K262252) that meets the same Class II requirements as existing resin agents; inventory and material-selection decisions are affected.
Key points
- Den-Mat Holdings, LLC received 510(k) clearance K262252 for MPa Max adhesive, classified as a tooth-bonding resin agent under 21 CFR 872.3200.
- The device received Traditional 510(k) clearance via the Substantially Equivalent pathway, product code KLE.
- Clearance is effective as of the date the FDA database entry is posted; practices can stock the product once it is commercially available.
- No additional labeling, training, or billing-code changes are specified in the clearance record.
Who should care
OwnerAssociateStaff
Read the original on openFDA Dental Devices
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