510(k) K851640
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1985
- Date Received
- April 11, 1985
- 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