BISICO Exact N 00310

GUDID EBIB003101

condensation-curing dental impression silicone

bisico Bielefelder Dentalsilicone GmbH & Co. KG

Silicone dental impression material
Primary Device IDEBIB003101
NIH Device Record Key0d055953-cc0b-426c-a956-b1751fa48693
Commercial Distribution StatusIn Commercial Distribution
Brand NameBISICO Exact N
Version Model Number00310
Catalog Number00310
Company DUNS316133664
Company Namebisico Bielefelder Dentalsilicone GmbH & Co. KG
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de
Phone+495218016800
Emailinfo@bisico.de

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBIB003101 [Primary]

FDA Product Code

EBHMaterial, Impression Tray, Resin
ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-30
Device Publish Date2020-06-03

Devices Manufactured by bisico Bielefelder Dentalsilicone GmbH & Co. KG

EBIB001101 - BISICO Plast2023-07-06 condensation-curing dental impression silicone
EBIB012001 - BISICO S3 Heavy 2x170ml2023-07-06 Addition-curing dental impression silicone
EBIB019101 - BISICO Dispenser 502023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
EBIB019201 - BISICO Dispenser 752023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
EBIB019401 - BISICO Dispenser 252023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
EBIB020201 - BISICO Dispenser 4:12023-07-06 A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into
EBIB712301 - BISICO S3 i Heavy 4x75ml2023-07-06 Addition-curing dental impression silicone
EBIB723211 - BISICO S4 suhy - impressa sure light2023-07-06 Addition-curing dental impression silicone

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