510(k) K851713
K851713 is an FDA 510(k) premarket notification submitted by Artiberia for the device "680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code EMJ (Elevator, Surgical, Dental), a Class I device regulated under 21 CFR 872.4565. Artiberia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1985
- Date Received
- April 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Surgical, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type