FDA.reportPublic FDA data

Pink CAD/CAM Disc

Primary DI
EPOLPMMPML10400
Brand
Pink CAD/CAM Disc
Company
POLIDENT d.o.o.
Model
PMMPML.1040
Catalog number
PMMPML.1040
Device description
PINK CAD/CAM disc G71-27-95-Z
Published
2025-12-05
Public version status
New
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
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153546000PINK CAD/CAM discPolident D.O.O., Dental Products Industry2016-09-28EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPOLPMMPML10400PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+38653304840polident@polident.si

Regulatory Flags#

DUNS number
644778409
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPOLPMMP484Pink CAD/CAM DiscPMMP.484PMMP.4842021-06-15
EPOLPMMP485Pink CAD/CAM DiscPMMP.485PMMP.4852021-06-15
EPOLPMMP486Pink CAD/CAM DiscPMMP.486PMMP.4862021-06-15
EPOLPMMP487Pink CAD/CAM DiscPMMP.487PMMP.4872021-06-15
EPOLPMMPML10300Pink CAD/CAM DiscPMMPML.1030PMMPML.10302025-12-05
EPOLPMMPML10310Pink CAD/CAM DiscPMMPML.1031PMMPML.10312025-12-05
EPOLPMMPML10320Pink CAD/CAM DiscPMMPML.1032PMMPML.10322025-12-05
EPOLPMMPML10330Pink CAD/CAM DiscPMMPML.1033PMMPML.10332025-12-05
EPOLPMMPML10340Pink CAD/CAM DiscPMMPML.1034PMMPML.10342025-12-05
EPOLPMMPML10350Pink CAD/CAM DiscPMMPML.1035PMMPML.10352025-12-05
EPOLPMMPML10360Pink CAD/CAM DiscPMMPML.1036PMMPML.10362025-12-05
EPOLPMMPML10370Pink CAD/CAM DiscPMMPML.1037PMMPML.10372025-12-05
EPOLPMMPML10380Pink CAD/CAM DiscPMMPML.1038PMMPML.10382025-12-05
EPOLPMMPML10390Pink CAD/CAM DiscPMMPML.1039PMMPML.10392025-12-05
EPOLPMMPML10410Pink CAD/CAM DiscPMMPML.1041PMMPML.10412025-12-05
EPOLPMMPML10420Pink CAD/CAM DiscPMMPML.1042PMMPML.10422025-12-05
EPOLPMMPML10430Pink CAD/CAM DiscPMMPML.1043PMMPML.10432025-12-05
EPOLPMMPML10440Pink CAD/CAM DiscPMMPML.1044PMMPML.10442025-12-05
EPOLPMMPML10450Pink CAD/CAM DiscPMMPML.1045PMMPML.10452025-12-05
EPOLPMMPML10460Pink CAD/CAM DiscPMMPML.1046PMMPML.10462025-12-05

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