510(k) K222357
K222357 is an FDA 510(k) premarket notification submitted by Denmat Holding, LLC for the device "DenMat Glutaraldehyde Desensitizer". The FDA issued a decision of Substantially Equivalent on August 9, 2022. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Denmat Holding, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2022
- Date Received
- August 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type