PRG Barrier Coat 1786

GUDID E23517860

PRG BARRIER COAT MINI KIT

SHOFU DENTAL CORPORATION

Dental coating, tooth-desensitizing
Primary Device IDE23517860
NIH Device Record Key96181c61-5de3-4b6c-99d5-5b8d4b38db27
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRG Barrier Coat
Version Model Number1786
Catalog Number1786
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius
Handling Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23517860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-23

On-Brand Devices [PRG Barrier Coat]

E23517950PRG BARRIER COAT
E23517860PRG BARRIER COAT MINI KIT
E235Y29100PRG BARRIER COAT SET BOTTLE TYPE

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