FDA.report

Ufi Gel hard C

Primary DI
E22122161
Brand
Ufi Gel hard C
Company
VOCO GmbH
Model
2216
Catalog number
2216
Device description
Hard direct denture relining.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22122161PrimaryHIBCC0

GMDN Terms

TermDefinition
Denture reliner, hardA denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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