510(k) K823684
K823684 is an FDA 510(k) premarket notification submitted by United Dental Mfg., Inc. for the device "FILE TYPE K ENDODONTIC". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. United Dental Mfg., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1982
- Date Received
- December 7, 1982
- 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