Data / Medical devices / United States / Drake Precision Dental Laboratory, Inc.
Drake Precision Dental Laboratory, Inc.: FDA-registered device maker in Charlotte, NC, United States, 1 510(k) clearance
Drake Precision Dental Laboratory, Inc. is registered with the FDA (registration 3002706372) in Charlotte, NC, United States. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002706372
- Address
- 8510 Crown Crescent Ct, Charlotte, NC, United States, 28227
- Owner or operator
- DRAKE PRECISION DENTAL LABORATORY (9098906)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 29, 2009
- Registered through
- 2026
- Brand names listed
- BIALEX Lead Screen Check, ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE, TAP 3 TL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry | JKL | 1 | Contract manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Repackager or relabeler | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Repackager or relabeler | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 9, 2020 | K200005 | Concinnity Aligners | NXC | Substantially Equivalent | Drake Precision Dental Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Aligner, Sequential
- All makers of Dentures, Partial
- All makers of Restoration, Noble Metal
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Dentures, Full
- All makers of Restoration, Base Metal
Updated November 9, 2020. 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.