510(k) K922633
K922633 is an FDA 510(k) premarket notification submitted by E&D Dental Products, Inc. for the device "CAVI-ZYME". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code EJB (Handle, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. E&D Dental Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1992
- Date Received
- May 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handle, Instrument, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type