The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Trend Set 2 Plus.
Device ID | K936070 |
510k Number | K936070 |
Device Name: | TREND SET 2 PLUS |
Classification | Material, Impression |
Applicant | CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
Contact | Sharon A Lutton |
Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-20 |
Decision Date | 1994-02-04 |