510(k) K851640
K851640 is an FDA 510(k) premarket notification submitted by Edward O. Goodwich for the device "TIP TOLEDO INCISOR PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 18, 1985. The device falls under product code BRW (Protector, Dental), a Class I device regulated under 21 CFR 868.5820.
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