Data / Medical devices / United States / DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental: FDA-registered device maker in Scottsdale, AZ, United States, 5 510(k) clearances
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) / Digital Dental is registered with the FDA (registration 3010127342) in Scottsdale, AZ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 24, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010127342
- Address
- 17250 N Hartford Dr Ste 125, Scottsdale, AZ, United States, 85255
- Owner or operator
- Dental Laboratory Milling Supplies LLC, DBA Digital Dental (10043367)
- Roles
- Specification developer
- First device listed
- November 25, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | 2 | Specification developer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Specification developer | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2018 | K173643 | Trilor Disks, Blocks and Arches | EBF | Substantially Equivalent | Bioloren S.R.L. | accessdata.fda.gov |
| May 6, 2015 | K150056 | Luxisse+ | EIH | Substantially Equivalent | Heany Industries, Inc. | accessdata.fda.gov |
| February 10, 2014 | K130991 | NEXXZR(TM)T AND NEXXZR(TM)S | EIH | Substantially Equivalent | Sagemax Bioceramics, Inc. | accessdata.fda.gov |
| September 24, 2013 | K130654 | CRYSTAL ULTRA | EIH | Substantially Equivalent | Dental Laboratory Milling Supplies, LLC (Dlms) | accessdata.fda.gov |
| July 20, 2011 | K111291 | AIDITE ZIRCONIA DENTAL CERAMICS | EIH | Substantially Equivalent | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Powder, Porcelain
- All makers of Teeth, Porcelain
Updated February 24, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.