510(k) K844238
K844238 is an FDA 510(k) premarket notification submitted by Dental Concepts, LLC for the device "ORAPIK PERIODONTAL SCALER". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code JET (Pick, Massaging), a Class I device regulated under 21 CFR 872.6650. Dental Concepts, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1984
- Date Received
- November 1, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pick, Massaging
- Device Class
- Class I
- Regulation Number
- 872.6650
- Review Panel
- DE
- Submission Type