The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Dentray Ii Plus Tray Adhesive.
Device ID | K952930 |
510k Number | K952930 |
Device Name: | DENTRAY II PLUS TRAY ADHESIVE |
Classification | Material, Impression |
Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
Contact | Sharon A Lutton |
Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-19 |
Decision Date | 1995-09-08 |