510(k) K081017
K081017 is an FDA 510(k) premarket notification submitted by Clinician'S Choice Dental Products, Inc. for the device "TEMPLATE AND COUNTER-FIT". The FDA issued a decision of Substantially Equivalent on August 4, 2008. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Clinician'S Choice Dental Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2008
- Date Received
- April 9, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type