PRG Barrier Coat Y2910

GUDID E235Y29100

PRG BARRIER COAT SET BOTTLE TYPE

SHOFU DENTAL CORPORATION

Dental coating, tooth-desensitizing, professional
Primary Device IDE235Y29100
NIH Device Record Keyeb264f47-6b17-433c-8407-60f7fb85be58
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRG Barrier Coat
Version Model NumberY2910
Catalog NumberY2910
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
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@shofu.com
Phone760-566-3528
Emailckaemmerlen@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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE235Y29100 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-13
Device Publish Date2024-03-05

On-Brand Devices [PRG Barrier Coat]

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

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