The following data is part of a premarket notification filed by Dental Solutions, Inc. with the FDA for Naturaz Series, Model B16,b20, B42, B60, B98, B100.
Device ID | K091096 |
510k Number | K091096 |
Device Name: | NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 |
Classification | Powder, Porcelain |
Applicant | DENTAL SOLUTIONS, INC. 9301 WILSHIRE BLVD PH5 Beverly, CA 90210 |
Contact | Andrew Paeng |
Correspondent | Andrew Paeng DENTAL SOLUTIONS, INC. 9301 WILSHIRE BLVD PH5 Beverly, CA 90210 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-16 |
Decision Date | 2009-06-18 |
Summary: | summary |