510(k) K875091
K875091 is an FDA 510(k) premarket notification submitted by Mission White Dental, Inc. for the device "ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT". The FDA issued a decision of Substantially Equivalent on February 29, 1988. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Mission White Dental, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 29, 1988
- Date Received
- December 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type