Plaquit D38123US

GUDID E239D38123US1

No.

Dreve Dentamid GmbH

Dental restorative material varnish
Primary Device IDE239D38123US1
NIH Device Record Key88379786-0bc9-4e9f-bb68-9b14a9c9a24d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlaquit
Version Model NumberD38123US
Catalog NumberD38123US
Company DUNS388000846
Company NameDreve Dentamid GmbH
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+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de
Phone+49230388070
Emaildentamid@dreve.de

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239D38123US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBDCoating, filling material, resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-24
Device Publish Date2024-04-16

On-Brand Devices [Plaquit]

E239D381241No.
E239D381231No.
E239D38124US1No.
E239D38123US1No.

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