510(k) K974622
K974622 is an FDA 510(k) premarket notification submitted by Micro Dental Laboratories for the device "DENTAL D". The FDA issued a decision of Substantially Equivalent on February 10, 1998. The device falls under product code EHP (Clasp, Preformed), a Class I device regulated under 21 CFR 872.3285. Micro Dental Laboratories has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1998
- Date Received
- December 11, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clasp, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3285
- Review Panel
- DE
- Submission Type