FDA.reportPublic FDA data

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Primary DI
E22116281
Brand
Quick Up
Company
VOCO GmbH
Model
1628
Catalog number
1628
Published
2017-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110440000QUICK UPVoco GmbH2011-05-04EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22116281PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E22190701TwinWave907090702026-08-18
E22122751VOCO Profluorid Varnish + BioMin227522752026-07-26
E22122661VOCO Profluorid Varnish + BioMin226622662026-05-06
E22122671VOCO Profluorid Varnish + BioMin226722672026-05-06
E22122681VOCO Profluorid Varnish + BioMin226822682026-05-06
E22122691VOCO Profluorid Varnish + BioMin226922692026-05-06
E22122701VOCO Profluorid Varnish + BioMin227022702026-05-06
E22122711VOCO Profluorid Varnish + BioMin227122712026-05-06
E22122721VOCO Profluorid Varnish + BioMin227222722026-05-06
E22122731VOCO Profluorid Varnish + BioMin227322732026-05-06
E22122741VOCO Profluorid Varnish + BioMin227422742026-05-06
E22122761VOCO Profluorid Varnish + BioMin227622762026-05-06
E22122771VOCO Profluorid Varnish + BioMin227722772026-05-06
E22122781VOCO Profluorid Varnish + BioMin227822782026-05-06
E22122791VOCO Profluorid Varnish + BioMin227922792026-05-06
E22163141Grandio disc multicolor631463142026-04-30
E22163151Grandio disc multicolor631563152026-04-30
E22163161Grandio disc multicolor631663162026-04-30
E22163171Grandio disc multicolor631763172026-04-30
E22163181Grandio disc multicolor631863182026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBI2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078376major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078802major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078819major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078826major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078833major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078840major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640080751major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08720604634235Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
08720604634242Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27