Fit Test C & B 2095

GUDID E22120951

Addition-curing silicone material for checking of prosthetic reconstructions.

VOCO GmbH

Silicone dental impression material
Primary Device IDE22120951
NIH Device Record Key572d97bf-99c0-4ebc-adfd-9d05f05b5da5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFit Test C & B
Version Model Number2095
Catalog Number2095
Company DUNS316699578
Company NameVOCO GmbH
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

Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22120951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-22

Devices Manufactured by VOCO GmbH

E22110561 - Bifix Temp2025-01-30 Bifix Temp is a dual-curing, composite-based temporary luting material.
E2212248 - Sticky Tim2025-01-30
E22162481 - Grandio disc multicolor2025-01-30 multicolor A1 12mm
E22162491 - Grandio disc multicolor2025-01-30 multicolor A2 12mm
E22162501 - Grandio disc multicolor2025-01-30 multicolor A3 12mm
E22162511 - Grandio disc multicolor2025-01-30 multicolor A3.5 12mm
E22162521 - Grandio disc multicolor2025-01-30 multicolor B1 12mm
E22162531 - Grandio disc multicolor2025-01-30 multicolor C2 12mm

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