510(k) K843017
K843017 is an FDA 510(k) premarket notification submitted by United Dental Mfg., Inc. for the device "ABSORBENT ENDODONTIC POINT". The FDA issued a decision of Substantially Equivalent on January 9, 1985. The device falls under product code EKN (Point, Paper, Endodontic), a Class I device regulated under 21 CFR 872.3830. United Dental Mfg., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1985
- Date Received
- July 31, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Point, Paper, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.3830
- Review Panel
- DE
- Submission Type