510(k) K873671
K873671 is an FDA 510(k) premarket notification submitted by Coltene, Inc. for the device "COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 1987. The device falls under product code EKS (File, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Coltene, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1987
- Date Received
- September 11, 1987
- 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