Pre-contoured Metal Bands

GUDID 00348783004854

PRE-CONTOURED METAL BANDS

PREMIER DENTAL PRODUCTS COMPANY

Dental matrix band, single-use
Primary Device ID00348783004854
NIH Device Record Keye4b7cad7-9e0a-4cf6-ad0d-e602258b3ce6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-contoured Metal Bands
Version Model Number9061070
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100348783004854 [Primary]

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 Date2024-08-14
Device Publish Date2024-08-06

Devices Manufactured by PREMIER DENTAL PRODUCTS COMPANY

00348783012989 - Enamel Pro® Prophy Paste2025-07-24 Enamel Pro® Prophy Paste Grape-Medium
00348783005134 - RC-Prep2025-07-17 RC PREP PLASTIC 9G SYR TIP REFILL (50)
00348783005141 - RC-Prep2025-07-17 RC-PREP 3CC SYRINGE TIP REFILL (50)
00348783005158 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Fine (Box of 200)
00348783005165 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Medium
00348783005172 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse
00348783005189 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Extra Coarse
00348783005196 - Enamel Pro® Prophy Paste2025-07-17 Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.