510(k) K020178
K020178 is an FDA 510(k) premarket notification submitted by Kerr Dental Materials Center for the device "BELLEGLASS HP MODELING GEL". The FDA issued a decision of Substantially Equivalent on March 15, 2002. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Kerr Dental Materials Center has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2002
- Date Received
- January 18, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type