White Bite PB02

GUDID 00850056330718

Pediatric Preformed Matrix Band 02

White Bite, Inc.

Dental matrix band, reusable
Primary Device ID00850056330718
NIH Device Record Keyfd034383-06f6-469e-b84a-be7605e77fae
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhite Bite
Version Model NumberPB02
Catalog NumberPB02
Company DUNS174136221
Company NameWhite Bite, Inc.
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100850056330718 [Primary]
GS110850056330715 [Unit of Use]

FDA Product Code

JEPRetainer, Matrix

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-18
Device Publish Date2025-06-10

On-Brand Devices [White Bite]

00850056330701Pediatric Preformed Matrix Band 01
00850056330718Pediatric Preformed Matrix Band 02

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