Home GUDID 00348783012293 Premier Applicators
Primary DI 00348783012293
Brand Premier Applicators
Company PREMIER DENTAL PRODUCTS COMPANY
Model 8100118
Device description Burnisher/Applicator Chop 1 (Modified .8mm)
Published 2026-04-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EKJ Burnisher, Operative
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EKJ Burnisher, Operative Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00348783012293 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00348783012293 00348783012293 348783012293 0348783012293
GMDN Terms# Term, Definition table Term Definition Manual dental burnisher, reusable A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 014789663 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00348783009682 Premier Composite Instruments PREMIER DENTAL PRODUCTS COMPANY EKJ 2026-04-02 00348783009378 Premier Burnisher PREMIER DENTAL PRODUCTS COMPANY EKJ 2026-04-01 00348783009385 Premier Burnisher PREMIER DENTAL PRODUCTS COMPANY EKJ 2026-04-01 00348783009392 Premier Burnisher PREMIER DENTAL PRODUCTS COMPANY EKJ 2026-04-01 00348783009408 Premier Burnisher PREMIER DENTAL PRODUCTS COMPANY EKJ 2026-04-01 10889950147372 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147389 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147716 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147747 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147754 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147761 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147792 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147884 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950147914 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950148065 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 10889950148102 Hu-Friedy HU-FRIEDY MFG. CO., LLC EKJ 2026-02-24 00813677024978 PDT, Inc. PDT, INC. EKJ 2024-06-27 07898506811656 Quinelato Schobell Industrial Ltda EKJ 2022-12-08 07898506843459 Quinelato Schobell Industrial Ltda EKJ 2022-12-08 10889950004569 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004576 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004583 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004590 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004606 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004613 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004620 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004637 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004644 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004651 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12 10889950004668 HU-FRIEDY HU-FRIEDY MFG. CO., LLC EKJ 2020-11-12