The following data is part of a premarket notification filed by Iodent, Co. with the FDA for Hold-fast Denture Adhesive.
Device ID | K884999 |
510k Number | K884999 |
Device Name: | HOLD-FAST DENTURE ADHESIVE |
Classification | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-oxide Homopolymer |
Applicant | IODENT, CO. 1817 S. NEIL STREET, STE. B Champaign, IL 61820 |
Contact | Florence M Nacino |
Correspondent | Florence M Nacino IODENT, CO. 1817 S. NEIL STREET, STE. B Champaign, IL 61820 |
Product Code | KOL |
CFR Regulation Number | 872.3410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-01 |
Decision Date | 1989-02-24 |