FDA.reportPublic FDA data

Promolux High Impact

Primary DI
D7091025120
Brand
Promolux High Impact
Company
Merz Dental GmbH
Model
Promolux High Impact Polymer, pink, 1000g
Catalog number
1025120
Device description
Promolux High Impact Polymer, pink, 1000g
Published
2025-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K130076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130076000PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCSMerz Dental GmbH2013-08-22EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7091025120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1000Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494381403411claudia.bobrowski@merz-dental.de

Regulatory Flags#

DUNS number
324914910
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7091084040M-PRINT Surgical GuideM-PRINT Surgical guide ice-blue, 1000 g10840402022-02-18
D7091019183M-PM DiscM-PM Disc, PMMA-Disc, shade BL4 translucent ZIR th10191832016-09-24
D7091019186M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent ZIR thi10191862016-09-24
D7091019187M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent ZIR thi10191872016-09-24
D7091019188M-PM DiscM-PM Disc, PMMA-Disc, shade A3.5 translucent ZIR t10191882016-09-24
D7091019189M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent ZIR thi10191892016-09-24
D7091019236M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10192362020-04-07
D7091019237M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10192372020-04-07
D7091019238M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10192382020-04-07
D7091019239M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10192392020-04-07
D7091019240M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10192402020-04-07
D7091019420M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10194202019-12-05
D7091019421M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10194212019-12-05
D7091019422M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10194222019-12-05
D7091019423M-PM DiscM-PM Disc, PMMA-Disc, shade A3,5 translucent thick10194232019-12-05
D7091019424M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent thickne10194242019-12-05
D7091019425M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10194252019-12-05
D7091019426M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10194262019-12-05
D7091019427M-PM DiscM-PM Disc, PMMA-Disc, shade B3 translucent thickne10194272019-12-05
D7091019428M-PM DiscM-PM Disc, PMMA-Disc, shade B4 translucent thickne10194282019-12-05

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Primary DI, Brand, Company table
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06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
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