510(k) K935713
K935713 is an FDA 510(k) premarket notification submitted by Fvtnks for the device "WILEY/ESPOSITO DENTAL GUARD". The FDA issued a decision of Substantially Equivalent on January 5, 1994. The device falls under product code BRW (Protector, Dental), a Class I device regulated under 21 CFR 868.5820. Fvtnks has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1994
- Date Received
- November 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Dental
- Device Class
- Class I
- Regulation Number
- 868.5820
- Review Panel
- AN
- Submission Type