Radent Prophy Paste Medium Grit Bubblegum Non Fluoride Jar 13500

GUDID 00310866001616

Prophy Paste without Sodium Fluoride; medium grit, bubblegum flavor, 12oz jar

PASCAL COMPANY, INC.

Dentifrice
Primary Device ID00310866001616
NIH Device Record Key55327843-3600-48fa-a3e2-2bb055927264
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadent Prophy Paste Medium Grit Bubblegum Non Fluoride Jar
Version Model Number13500
Catalog Number13500
Company DUNS009260217
Company NamePASCAL COMPANY, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004268051
Emailpascal@pascaldental.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100310866001616 [Primary]

FDA Product Code

EJRAgent, Polishing, Abrasive, Oral Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-01
Device Publish Date2019-01-29

Devices Manufactured by PASCAL COMPANY, INC.

00310866002552 - KOIS KR-1 PACKER2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD
00310866002606 - KOIS KR-2 PACKER2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 1MM HEAD
00310866002613 - KOIS KR-3 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 1.5MM HEAD
00310866002620 - KOIS KR-4 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD
00310866002637 - KOIS KR-5 PACKER2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2.5MM HEAD
00310866002644 - GET SCULPTED2024-05-24 Wax Carving Set
00310866002651 - Fluorilaq Salted Caramel (10mL) Tube2024-04-05 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments.
00310866002668 - Fluorilaq Mint (10mL) Tube2024-04-05 5% Fluoride Varnish with Xylitol. Ideal for cavity varnish.

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