Registered with FDA
Premiere 1 Dental Laboratory, LLC
Bradenton, FL, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Premiere 1 Dental Laboratory, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Crown, Bridge, Temporary Resin, Porcelain Crown | 2007 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Lister | Alloy, Gold, Base Metal | 2007 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Lister | Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture, | 2007 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Premiere 1 Dental Laboratory, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply International, Inc. (1), Valplast Intl. Corp. (1), Advanced Marketing Research Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 May 2006 | K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | Dentsply International, Inc. | EBG Resin Temporary Crown and Bridge |
| 7 Apr 2006 | K060507 | VALPLAST YAMAHACHI TEETH | Valplast Intl. Corp. | ELM Teeth Plastic Denture |
| 26 May 1978 | K780722 | ADVANCED DENTURE SYSTEM | Advanced Marketing Research Co. | EKO Denture Preformed (Partially Prefabricated Denture) |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREMIERE 1 DENTAL LABORATORY, L.L.C.FDA reg. 3006459726 | Bradenton, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9106559). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.