510(k) K031664
K031664 is an FDA 510(k) premarket notification submitted by Sybron Endo/Analytic for the device "ELEMENTS OBTURATION UNIT". The FDA issued a decision of Substantially Equivalent on April 28, 2004. The device falls under product code EKR (Plugger, Root Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Sybron Endo/Analytic has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2004
- Date Received
- May 29, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plugger, Root Canal, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type