FDA.reportPublic FDA data

PALA cre-active, red, 3 g

Primary DI
J014660334500
Brand
PALA cre-active, red, 3 g
Company
Kulzer GmbH
Model
66033450
Catalog number
66033450
Device description
Material tooth shade resin
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K914456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914456000DENTACOLOR(R) CRE-ACTIVEHeraeus Kulzer, Inc.1992-03-11EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J014660334500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)431-1785xxx@xxx.xxx

Regulatory Flags#

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

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J014661012770Retraxil blue66101277661012772026-04-21
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J014660969290Starlight pro66096929660969292026-01-28
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J014661002680VENUS Diamond FLOW66100268661002682024-10-24
J014661002690VENUS Diamond FLOW66100269661002692024-10-24
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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

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