Provicol QM 1109

GUDID E2211109

Eugenol-free temporary luting cement with calcium hydroxide.

VOCO GmbH

Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement Fatty acid dental cement
Primary Device IDE2211109
NIH Device Record Key3157540a-a26f-41a7-8dbb-6e8c6130bbef
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvicol QM
Version Model Number1109
Catalog Number1109
Company DUNS316699578
Company NameVOCO GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2211109 [Unit of Use]
HIBCCE22111091 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-07
Device Publish Date2020-08-28

On-Brand Devices [Provicol QM ]

E22110741Eugenol-free temporary luting cement with calcium hydroxide.
E22110991Eugenol-free temporary luting cement with calcium hydroxide.
E2211109Eugenol-free temporary luting cement with calcium hydroxide.

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