The following data is part of a premarket notification filed by Pacific Rim Dental, Inc. with the FDA for Genesis.
Device ID | K972871 |
510k Number | K972871 |
Device Name: | GENESIS |
Classification | Material, Impression |
Applicant | PACIFIC RIM DENTAL, INC. 173 SHADY LN. Stateline, NV 89449 |
Contact | Kathy L Eppen |
Correspondent | Kathy L Eppen PACIFIC RIM DENTAL, INC. 173 SHADY LN. Stateline, NV 89449 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-04 |
Decision Date | 1997-10-02 |