510(k) K892255
K892255 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "DENTAL ROOT ELEVATOR". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code EKO (Denture Preformed (Partially Prefabricated Denture)), a Class II device regulated under 21 CFR 872.3600. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 1989
- Date Received
- April 4, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture Preformed (Partially Prefabricated Denture)
- Device Class
- Class II
- Regulation Number
- 872.3600
- Review Panel
- DE
- Submission Type