510(k) K010544
K010544 is an FDA 510(k) premarket notification submitted by Apex Dental Materials, Inc. for the device "VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin), a Class II device regulated under 21 CFR 872.3750. Apex Dental Materials, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2001
- Date Received
- February 23, 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