Data / Medical devices / United States / Premiere 1 Dental Laboratory, L.L.C.
Premiere 1 Dental Laboratory, L.L.C.: FDA-registered device maker in Bradenton, FL, United States, 3 510(k) clearances
Premiere 1 Dental Laboratory, L.L.C. is registered with the FDA (registration 3006459726) in Bradenton, FL, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 23, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006459726
- Address
- 302 Manatee Avenue East Suite 201, Bradenton, FL, United States, 34208
- Owner or operator
- PREMIERE 1 DENTAL LABORATORY, L.L.C. (9106559)
- Roles
- Repackager or relabeler
- First device listed
- August 31, 2007
- Registered through
- 2026
- Brand names listed
- Alloy, Gold, Base Metal, Alloy, Noble Metal, Metal Crown, Base Metal, Metal Crown, Preformed Crown,, Crown, Bridge, Temporary Resin, Porcelain Crown, Denture, Acrylic Teeth, Denture, Partial Denture, Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth, Porcelain Fused to Metal, Crown, Restoration, Metal Crown, Porcelain Restoration, Porcelain Crown, Porcelain Fused to Metal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dentures, Full | NSL | N | Repackager or relabeler | 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 |
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 |
|---|---|---|---|---|---|---|
| May 23, 2006 | K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | EBG | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| April 7, 2006 | K060507 | VALPLAST YAMAHACHI TEETH | ELM | Substantially Equivalent | Valplast Intl. Corp. | accessdata.fda.gov |
| May 26, 1978 | K780722 | ADVANCED DENTURE SYSTEM | EKO | Substantially Equivalent | Advanced Marketing Research Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Base Metal
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Restoration, Porcelain
- All makers of Alloy, Gold-Based Noble Metal
- All makers of Restoration, Noble Metal
- All makers of Crown And Bridge, Temporary, Resin
Updated May 23, 2006. 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.