BONASCAN HEAVY

GUDID 05206569430127

Addition curing vinyl polysiloxane scannable impression 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
Primary Device ID05206569430127
NIH Device Record Key06e896c5-1a9d-46fd-9ccc-3d664f69582c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONASCAN HEAVY
Version Model NumberRegular Set, 50ml
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105206569000764 [Primary]
GS105206569001334 [Package]
Contains: 05206569000764
Package: Box [32 Units]
In Commercial Distribution
GS105206569430110 [Package]
Contains: 05206569000764
Package: Box [2 Units]
In Commercial Distribution
GS105206569430127 [Package]
Contains: 05206569000764
Package: Box [4 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 [BONASCAN HEAVY]

05206569430226Addition curing vinyl polysiloxane scannable impression material
05206569430127Addition curing vinyl polysiloxane scannable impression material

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