510(k) K923675
K923675 is an FDA 510(k) premarket notification submitted by Teledyne Getz for the device "DENSPRO MEDIUM MINT PROPHY PASTE". The FDA issued a decision of Substantially Equivalent on November 5, 1992. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Teledyne Getz has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1992
- Date Received
- July 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Polishing, Abrasive, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6030
- Review Panel
- DE
- Submission Type