The following data is part of a premarket notification filed by Dental Ventures Of America, Inc. with the FDA for C&b Resin Plus Powder/liquid, Models Retemp A2, A3, A3.5, Cl, Retemp B2, B3, C2, D3, Wh, Retemp Mo.
Device ID | K000894 |
510k Number | K000894 |
Device Name: | C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | DENTAL VENTURES OF AMERICA, INC. 217 LEWIS CT. Corona, CA 91720 |
Contact | Anthony Siragusa |
Correspondent | Anthony Siragusa DENTAL VENTURES OF AMERICA, INC. 217 LEWIS CT. Corona, CA 91720 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-20 |
Decision Date | 2000-05-19 |