FDA.report

Ufi Gel hard C

Primary DI
E22122171
Brand
Ufi Gel hard C
Company
VOCO GmbH
Model
2217
Catalog number
2217
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
E22122171PrimaryHIBCC0

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
E22190521GIC Mixer II905290522026-03-02
E22162701GrandioSO Unlimited627062702025-08-29
E22162761GrandioSO Unlimited627662762025-08-29
E22162771GrandioSO Unlimited627762772025-08-29
E22162941GrandioSO 4U629462942025-08-14
E22116451MTA vpt164516452025-07-07
E22162821GrandioSO 4U628262822025-06-02
E22162831GrandioSO 4U628362832025-06-02
E22162841GrandioSO 4U628462842025-06-02
E22162851GrandioSO 4U628562852025-06-02
E22162861GrandioSO 4U628662862025-06-02
E22162871GrandioSO 4U628762872025-06-02
E22162881GrandioSO 4U628862882025-06-02
E22162891GrandioSO 4U628962892025-06-02
E22162901GrandioSO 4U629062902025-06-02
E22162951GrandioSO 4U629562952025-06-02
E22162961GrandioSO 4U629662962025-06-02
E22162971GrandioSO 4U629762972025-06-02
E22162981GrandioSO 4U629862982025-06-02
E22162991GrandioSO 4U629962992025-06-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967025917RodinPac-Dent, Inc.EBI2026-03-23
00815967029342RodinPac-Dent, Inc.EBI2026-03-23
00815967029359RodinPac-Dent, Inc.EBI2026-03-23
00815967029366RodinPac-Dent, Inc.EBI2026-03-23
00815967029373RodinPac-Dent, Inc.EBI2026-03-23
06971437942314UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942192UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
00863995000123DenSureFitOTC DENTAL CORPORATIONEBI2026-02-26
EDET046341VITA VIONIC® BASE RESIN FLEX pink transparent 1000gDETAX GmbHEBI2026-02-04
EDET046351VITA VIONIC® BASE RESIN FLEX clear 1000gDETAX GmbHEBI2026-02-04
D87097961Harvest EasyGumHarvest Dental Products, LLCEBI2026-01-20