The following data is part of a premarket notification filed by Dental Milling Laboratory Supplies (dlms) with the FDA for Dlms-zirblocks.
Device ID | K082137 |
510k Number | K082137 |
Device Name: | DLMS-ZIRBLOCKS |
Classification | Powder, Porcelain |
Applicant | DENTAL MILLING LABORATORY SUPPLIES (DLMS) 14201 N. 87TH ST., SUITE A-105 Scottsdale, AZ 85260 |
Contact | Scott Atkin |
Correspondent | Scott Atkin DENTAL MILLING LABORATORY SUPPLIES (DLMS) 14201 N. 87TH ST., SUITE A-105 Scottsdale, AZ 85260 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-29 |
Decision Date | 2009-02-10 |
Summary: | summary |