PIC Plus Value Pack Shade Original

GUDID D6913001555

PREMIER IMPLANT CEMENT

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin
Primary Device IDD6913001555
NIH Device Record Key613e3dc5-01ee-4adb-9720-42c4082890a7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIC Plus Value Pack Shade Original
Version Model Number3001555
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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
HIBCCD6913001555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-16
Device Publish Date2020-01-08

Devices Manufactured by PREMIER DENTAL PRODUCTS COMPANY

00348783000672 - Brite Shield2024-06-28 BRITE SHIELD SAMPLE (1pk)
00348783000696 - CompCORE2024-06-28 CompCore Natural Shade - 50 gr
00348783000702 - CompCORE2024-06-28 CompCore Natural Shade - 28 gr
00348783003796 - Brite Shield2024-06-28 BRITE SHIELD (CASE OF 6)
00348783003802 - Brite Shield2024-06-28 Brite Shield Sample INTL w/Illustration Card
00348783003819 - Brite Shield2024-06-28 CLEANER SAMPLE PACK (BS/VA)
00348783003826 - Pro Clean2024-06-28 PRO CLEAN STAIN CLEANER (SINGLE BOX of 25)
00348783003833 - Pro Clean2024-06-28 PRO CLEAN STAIN CLEANER (CASE OF 10)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.