The following data is part of a premarket notification filed by Dental Laboratory Milling Supplies Llc (dlms) with the FDA for Crystal Ultra.
Device ID | K130654 |
510k Number | K130654 |
Device Name: | CRYSTAL ULTRA |
Classification | Powder, Porcelain |
Applicant | DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) 14201 N 87TH ST #A101 Scottsdale, AZ 85260 |
Contact | Scott Atkin |
Correspondent | Scott Atkin DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) 14201 N 87TH ST #A101 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 | 2013-03-12 |
Decision Date | 2013-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EDMC45033000020 | K130654 | 000 |
EDMC47023000010 | K130654 | 000 |
EDMC47023000000 | K130654 | 000 |
EDMC46353000030 | K130654 | 000 |
EDMC46353000020 | K130654 | 000 |
EDMC46353000010 | K130654 | 000 |
EDMC46353000000 | K130654 | 000 |
EDMC46203000030 | K130654 | 000 |
EDMC46203000020 | K130654 | 000 |
EDMC46203000010 | K130654 | 000 |
EDMC46203000000 | K130654 | 000 |
EDMC46013000030 | K130654 | 000 |
EDMC46013000020 | K130654 | 000 |
EDMC46013000010 | K130654 | 000 |
EDMC46013000000 | K130654 | 000 |
EDMC47023000020 | K130654 | 000 |
EDMC47023000030 | K130654 | 000 |
EDMC45033000010 | K130654 | 000 |
EDMC45033000000 | K130654 | 000 |
EDMC45023000030 | K130654 | 000 |
EDMC45023000020 | K130654 | 000 |
EDMC45023000010 | K130654 | 000 |
EDMC45023000000 | K130654 | 000 |
EDMC45013000040 | K130654 | 000 |
EDMC45013000030 | K130654 | 000 |
EDMC45013000020 | K130654 | 000 |
EDMC45013000010 | K130654 | 000 |
EDMC48023000030 | K130654 | 000 |
EDMC48023000020 | K130654 | 000 |
EDMC48023000010 | K130654 | 000 |
EDMC48023000000 | K130654 | 000 |
EDMC45033000030 | K130654 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CRYSTAL ULTRA 88628544 not registered Live/Pending |
Dental Milling Solutions 2019-09-24 |