510(k) K851721
K851721 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code EMN (Scaler, Periodontic), 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
- July 2, 1985
- Date Received
- April 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Periodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type