510(k) K791019
K791019 is an FDA 510(k) premarket notification submitted by Techdent, Inc. for the device "MCSPADDEN CONDENSOR". The FDA issued a decision of Substantially Equivalent on August 3, 1979. 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
- August 3, 1979
- Date Received
- June 1, 1979
- 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