PIT & FISSURE SEALANT

GUDID 05206569866186

Light curing, fluoride releasing sealant. Radiopaque, resin-based dental material for the sealing of pits and fissures.

DMP DENTAL INDUSTRY S.A.

Dental pit/fissure sealant Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID05206569866186
NIH Device Record Key8284d6bb-f898-4182-894a-7f406c4df820
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIT & FISSURE SEALANT
Version Model NumberOpaque, 2g
Company DUNS728534814
Company NameDMP DENTAL INDUSTRY S.A.
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

Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com
Phone+302299023041
Emailinfo@dmpdental.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105206569864182 [Primary]
GS105206569866186 [Package]
Contains: 05206569864182
Package: Box [2 Units]
In Commercial Distribution

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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05206569001761 - BRIGHT TEMPORARY C&B2020-09-17 Temporary Crown & Bridge composite
05206569001778 - BRIGHT TEMPORARY C&B2020-09-17 Temporary Crown & Bridge composite
05206569001785 - BRIGHT TEMPORARY C&B2020-09-17 Temporary Crown & Bridge composite
05206569001792 - BRIGHT TEMPORARY C&B2020-09-17 Temporary Crown & Bridge composite
05206569001839 - BRIGHT TEMPORARY C&B2020-09-17 Temporary Crown & Bridge composite

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