GrandioSO Unlimited 6277

GUDID E22162771

light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, BL

VOCO GmbH

Dental composite resin
Primary Device IDE22162771
NIH Device Record Key1cacbfb9-53ff-4528-ac31-2fcdf7355e29
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrandioSO Unlimited
Version Model Number6277
Catalog Number6277
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 Usetrue
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
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx

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
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
HIBCCE22162771 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-08
Device Publish Date2025-08-29

On-Brand Devices [GrandioSO Unlimited]

E22162771light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, BL
E22162761light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, opaque
E22162701light-curing, radiopaque nano-hybrid universal composite, Set Caps 75x0.3g

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