The following data is part of a premarket notification filed by Artiberia with the FDA for 2020-1/2 To 2220 Various Dental Wax & Modelling Ca.
Device ID | K851727 |
510k Number | K851727 |
Device Name: | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA |
Classification | Carver, Wax, Dental |
Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Contact | Gil M Sanchez |
Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Product Code | EIK |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-07-02 |