FDA.reportPublic FDA data

Signum Opaque F

Primary DI
J014660468320
Brand
Signum Opaque F
Company
Kulzer GmbH
Model
66046832
Catalog number
66046832
Device description
Signum Opaque F, OR, 3g
Published
2023-09-25
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
EBFMaterial, tooth shade, resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230644000Signum opaque FKulzer, LLC2023-09-07EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J014660468320PrimaryHIBCC0

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)431-1785XX@XX.XX

Regulatory Flags#

DUNS number
315666321
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J014660872140Retraxil blue66087214660872142026-04-21
J014660872150Retraxil blue66087215660872152026-04-21
J014661012760Retraxil blue66101276661012762026-04-21
J014661012770Retraxil blue66101277661012772026-04-21
J014661012780Retraxil blue66101278661012782026-04-21
J014660164550Starlight pro66016455660164552026-01-28
J014660573650Starlight pro66057365660573652026-01-28
J014660968300Starlight pro66096830660968302026-01-28
J014660969290Starlight pro66096929660969292026-01-28
J014660971690Starlight pro66097169660971692026-01-28
J014660971700Starlight pro66097170660971702026-01-28
J014661002680VENUS Diamond FLOW66100268661002682024-10-24
J014661002690VENUS Diamond FLOW66100269661002692024-10-24
J014661002700VENUS Diamond FLOW66100270661002702024-10-24
J014661002710VENUS Diamond FLOW66100271661002712024-10-24
J014661002720VENUS Diamond FLOW66100272661002722024-10-24
J014661002730VENUS Diamond FLOW66100273661002732024-10-24
J014661002740VENUS Diamond FLOW66100274661002742024-10-24
J014661002750VENUS Diamond FLOW66100275661002752024-10-24
J014661003060VENUS Diamond FLOW66100306661003062024-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00195062160493Build-It FRKerr CorporationEBF2026-10-27
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06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25