FOLIDUR ALIGN 2108125100

GUDID E23921081251001

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic
Primary Device IDE23921081251001
NIH Device Record Keyb7228ec1-da2a-45cf-b419-e61a5d8b48be
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOLIDUR ALIGN
Version Model Number2108125100
Catalog Number2108125100
Company DUNS388000846
Company NameDreve Dentamid GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23921081251001 [Primary]

FDA Product Code

KMYPOSITIONER, TOOTH, PREFORMED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-19
Device Publish Date2024-09-11

On-Brand Devices [FOLIDUR ALIGN]

E23921101251001No.
E23921101201001No.
E23921081251001No.
E23921081201001No.
E23921061251001No.
E23921061201001No.

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