510(k) K905640
K905640 is an FDA 510(k) premarket notification submitted by The Hygenic Corp. for the device "SOLID CORE GUTTA PERCHA CARRIER". The FDA issued a decision of Substantially Equivalent on March 5, 1991. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. The Hygenic Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1991
- Date Received
- December 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Pulp Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type