510(k) K012761
K012761 is an FDA 510(k) premarket notification submitted by Prime Dental Manufacturing, Inc. for the device "PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT". The FDA issued a decision of Substantially Equivalent on November 1, 2001. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Prime Dental Manufacturing, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2001
- Date Received
- August 17, 2001
- 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