510(k) K042828
K042828 is an FDA 510(k) premarket notification submitted by Young O/S, LLC for the device "OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code EKR (Plugger, Root Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2004
- Date Received
- October 12, 2004
- Clearance Type
- Abbreviated
- 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