FDA.reportPublic FDA data

Signum Opaque F

Primary DI
J014660200670
Brand
Signum Opaque F
Company
Heraeus Kulzer GmbH
Model
66020067
Catalog number
66020067
Device description
Signum Opaque F, OA2, 3g
Published
2023-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
J014660200670PrimaryHIBCC0

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
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J014500354060PROVIL NOVO L. 1X280 ML50035406500354062024-09-09
J014500354120PROVIL NOVO P SOFT FAST 1X50050035412500354122024-09-09
J014656875141IOT white 9665687514656875142024-09-09
J014657670380CUTTERSIL P PLUS 1X900 ML65767038657670382024-09-09
J014658179300CUTTERSIL LIGHT GREEN 1X140 ML65817930658179302024-09-09
J014660007810Dispensing Gun 4:166000781660007812024-09-09
J014660007821IOT yellow 9666000782660007822024-09-09
J014660009051BITE REG INTRAORAL TIP CD 9666000905660009052024-09-09
J014660019700DISPENSING GUN 2 (1:1/2:1)66001970660019702024-09-09
J014660019881Mixing Tip yellow 1:1 4866001988660019882024-09-09
J014660019891Mixing Tip green 1:1 4866001989660019892024-09-09
J014660036390FLEXITIME HEAVY TRAY 1 X 50 ML SAMPLE66003639660036392024-09-09
J014660036400FLEXITIME MONO PHASE 1 X 50 ML SAMPLE66003640660036402024-09-09
J014660036410FLEXITIME CORRECT FLOW 1 X 50 ML SAMPLE66003641660036412024-09-09
J014660082900PROVIL NOVO L. F CD2 1X(2X50ML)66008290660082902024-09-09
J014660082910PROVIL NOVO MED. F CD2 1X(2X50ML)66008291660082912024-09-09
J014660082920PROVIL NOVO MED. R CD2 1X(2X50ML)66008292660082922024-09-09
J014660082930PROVIL NOVO MONO F CD 2 1X(2X50ML)66008293660082932024-09-09
J014660082940PROVIL NOVO MONO R CD2 1X(2X50ML)66008294660082942024-09-09
J014660360830Dispensing Gun 10:166036083660360832024-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23