510(k) K770091
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1977
- Date Received
- January 17, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture Repair Kit
- Device Class
- Class II
- Regulation Number
- 872.3570
- Review Panel
- DE
- Submission Type
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.