510(k) K101814
K101814 is an FDA 510(k) premarket notification submitted by Candulor USA, Inc. for the device "DIRECT CROWN NATURAL 1". The FDA issued a decision of Substantially Equivalent on September 27, 2010. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Candulor USA, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2010
- Date Received
- June 29, 2010
- 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