510(k) K012673
K012673 is an FDA 510(k) premarket notification submitted by Prime Dental Manufacturing, Inc. for the device "PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 24, 2001. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Prime Dental Manufacturing, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2001
- Date Received
- August 14, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Device Class
- Class II
- Regulation Number
- 872.3750
- Review Panel
- DE
- Submission Type