510(k) K924739
K924739 is an FDA 510(k) premarket notification submitted by Ranir/Dcp Corp. for the device "THE DENTIST'S TOOTH POLISHER". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code JEQ (Toothbrush, Powered), a Class I device regulated under 21 CFR 872.6865. Ranir/Dcp Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1992
- Date Received
- September 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Toothbrush, Powered
- Device Class
- Class I
- Regulation Number
- 872.6865
- Review Panel
- DE
- Submission Type