510(k) K884999
K884999 is an FDA 510(k) premarket notification submitted by Iodent, Co. for the device "HOLD-FAST DENTURE ADHESIVE". The FDA issued a decision of Substantially Equivalent on February 24, 1989. The device falls under product code KOL (Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer), a Class I device regulated under 21 CFR 872.3410.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1989
- Date Received
- December 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
- Device Class
- Class I
- Regulation Number
- 872.3410
- Review Panel
- DE
- Submission Type