510(k) K782080
K782080 is an FDA 510(k) premarket notification submitted by Caulk Co., Div. Dentsply for the device "VENEER SYSTEM, MOSTIQUE LAMINATE". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Caulk Co., Div. Dentsply has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1979
- Date Received
- December 13, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Tooth Bonding, Resin
- Device Class
- Class II
- Regulation Number
- 872.3200
- Review Panel
- DE
- Submission Type