PREMIERE 1 DENTAL LABORATORY, L.L.C.

FDA Device Registration & Listing · Bradenton, FL, US · Registration 3006459726

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006459726
FEI Number
3006459726
Entity Name
PREMIERE 1 DENTAL LABORATORY, L.L.C.
City/State/Country
Bradenton, FL, US
Establishment Address
302 Manatee Avenue East, Suite 201, Bradenton, FL 34208, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
PREMIERE 1 DENTAL LABORATORY, L.L.C. (Owner Number: 9106559)
Owner / Operator Contact Address
302 Manatee Avenue East, Suite 201, Bradenton, FL 34208, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture, Crown, Bridge, Temporary Resin, Porcelain Crown Alloy, Noble Metal, Metal Crown Denture, Acrylic Teeth, Denture, Partial Denture

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2007-08-31
EKO Denture Preformed (Partially Prefabricated Denture) Dental Class 2 872.3600 2007-08-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2007-08-31
NSJ Restoration, Noble Metal Unknown Class N N/A 2017-10-09
NSL Dentures, Full Unknown Class N N/A 2020-02-06

Official Correspondent

Domingo Hernandez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PREMIERE 1 DENTAL LABORATORY, L.L.C.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070591 Union Dental S.A./Unidesa.Odi REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH 2007-05-11
K915276 Nobelpharma USA, Inc. DENTURE PLASTIC TEETH,76 ELM 1992-02-03

Similar Registrations

Registration Number Establishment Name Location
3016564992 DENTAC LLC North Miami, FL, US
3042623520 ZINGO DIGITAL DENTAL LAB LLC Mount Prospect, IL, US
3010253209 ENTA B.V. Bergen op Zoom Noord-Brabant, NL
3007740664 Shenzhen Jiahong Dental Technology Co., Ltd Shenzhen Guangdong, CN
3002727993 GEBDI DENTAL PRODUCTS GMBH Engen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006459726. Last updated year: 2026. Please use registration number 3006459726 when referencing this establishment in official correspondence.
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