Plicafol 03910

GUDID EBIB039101

Placeholder film for dental film impressions

bisico Bielefelder Dentalsilicone GmbH & Co. KG

Wax dental impression material
Primary Device IDEBIB039101
NIH Device Record Keyeebd1122-144e-4ed5-aae3-8a6e4a63a500
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlicafol
Version Model Number03910
Catalog Number03910
Company DUNS316133664
Company Namebisico Bielefelder Dentalsilicone GmbH & Co. KG
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+495218016800
Emailinfo@bisico.de

Operating and Storage Conditions

Handling Environment TemperatureBetween 7 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBIB039101 [Primary]

FDA Product Code

EGDWax, Dental, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-06-29
Device Publish Date2020-06-05

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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