BONA-BITE Air

GUDID 05206569000047

Addition curing silicone bite registration material

DMP DENTAL INDUSTRY S.A.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material
Primary Device ID05206569000047
NIH Device Record Key7e410d2f-e3c7-4aab-ad39-63f45b95845e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONA-BITE Air
Version Model Number50ml
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
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 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105206569000023 [Package]
Contains: 05206569000221
Package: Box [2 Units]
In Commercial Distribution
GS105206569000047 [Package]
Contains: 05206569000221
Package: Box [4 Units]
In Commercial Distribution
GS105206569000221 [Primary]
GS105206569001457 [Package]
Contains: 05206569000221
Package: Box [32 Units]
In Commercial Distribution
GS105206569002096 [Package]
Contains: 05206569000221
Package: Box starter pack [2 Units]
In Commercial Distribution

FDA Product Code

ELWMaterial, Impression

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

On-Brand Devices [BONA-BITE Air]

05206569000054Addition curing silicone bite registration material
05206569000047Addition curing silicone bite registration material
05206569001235Addition curing silicone bite registration material
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