Premier Burnisher

GUDID 00348783009361

Burnisher DE_26/27S

PREMIER DENTAL PRODUCTS COMPANY

Manual dental burnisher, reusable
Primary Device ID00348783009361
NIH Device Record Key98e3cc8a-405b-435f-9bb3-b354fada4c55
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Burnisher
Version Model Number1003027
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783009361 [Primary]

FDA Product Code

EKJBurnisher, Operative

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


[00348783009361]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-25
Device Publish Date2026-03-17

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00348783006018 - Premier Explorers2026-03-25 CAVITY FINDER DE 6/23

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