FDA.reportPublic FDA data

VITAVM LC

Primary DI
J017CVLCPGK0
Brand
VITAVM LC
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
CVLCPGK
Device description
VITAVM®LC paste GINGIVA KIT
Published
2018-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961434000VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEMVident1996-07-08EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J017CVLCPGK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)8283839info@vitanorthamerica.com

Regulatory Flags#

DUNS number
315165357
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J017BLSKCV20VITA LUMEX® ACBLSKCV22026-09-24
J017BLSKV20VITA LUMEX® ACBLSKV22026-09-24
J017BLSTKCV20VITA LUMEX® ACBLSTKCV22026-09-24
J017BV13BK12CV50VITA VM®13BV13BK12CV52026-09-24
J017BV13BK12V50VITA VM®13BV13BK12V52026-09-24
J017BV13BKS12V50VITA VM®13BV13BKS12V52026-09-24
J017BV13GKV20VITA VM®13BV13GKV22026-09-24
J017BV13MKV20VITA VM®13BV13MKV22026-09-24
J017BV9GKV20VITA VM®9BV9GKV22026-09-24
J017BV9MKV20VITA VM®9BV9MKV22026-09-24
J017BVMKSETCV30VITA VMK Master®BVMKSETCV32026-09-24
J017LAMSKCV20VITA AMBRIA®LAMSKCV22026-09-24
J017CVMLP0140VITA VM®LCCVMLP0142026-05-07
J017CVMLP0240VITA VM®LCCVMLP0242026-05-07
J017CVMLPSET0VITA VM®LCCVMLPSET2026-05-07
J017EDCYM89830020VITA YZ® SOLUTIONSEDCYM89830022026-04-10
J017EDCYM89830030VITA YZ® SOLUTIONSEDCYM89830032026-04-10
J017EDCYM89830040VITA YZ® SOLUTIONSEDCYM89830042026-04-10
J017EDCYM89830360VITA YZ® SOLUTIONSEDCYM89830362026-04-10
J017EDCYM89830370VITA YZ® SOLUTIONSEDCYM89830372026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
00810111543644QuantiumBISCO INC.EBF2026-10-12
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBF2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
08806383540995DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541008DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07