DD base P HI

Primary DI
EDDIK503301
Brand
DD base P HI
Company
Dental Direkt GmbH
Model
98H30 sun
Catalog number
K50330
Device description
DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems.DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures.DD base P HI is suitable for longterm use in the oral cavity up to 10 years.
Published
2023-07-10
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230410000DD medical polymers (PMMA)Dental Direkt GmbH2023-06-23EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDDIK503301PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height30Millimeter
Outer Diameter98.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+495225863190info@dentaldirekt.de

Regulatory Flags#

DUNS number
313214171
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDDIG520100001DD Bio ZW iso color98H10 1000G520100002024-08-27
EDDIG520133301DD Bio ZW iso color98H10 1333G520133302024-08-27
EDDIG2310011DD Bio ZX² color 71H14 lightG2310012016-10-05
EDDIG2310021DD Bio ZX² color 71H14 mediumG2310022016-10-05
EDDIG2310031DD Bio ZX² color 71H14 intenseG2310032016-10-05
EDDIG2310041DD Bio ZX² color 71H14 low chromaticG2310042016-10-05
EDDIG2310051DD Bio ZX² color 71H14 high chromaticG2310052016-10-05
EDDIG2320011DD Bio ZX² color 71H16 lightG2320012016-10-05
EDDIG2320021DD Bio ZX² color 71H16 mediumG2320022016-10-05
EDDIG2320031DD Bio ZX² color 71H16 intenseG2320032016-10-05
EDDIG2320041DD Bio ZX² color 71H16 low chromaticG2320042016-10-05
EDDIG2320051DD Bio ZX² color 71H16 high chromaticG2320052016-10-05
EDDIG2330011DD Bio ZX² color 71H20 lightG2330012016-10-05
EDDIG2330021DD Bio ZX² color 71H20 mediumG2330022016-10-05
EDDIG2330031DD Bio ZX² color 71H20 intenseG2330032016-10-05
EDDIG2330041DD Bio ZX² color 71H20 low chromaticG2330042016-10-05
EDDIG2330051DD Bio ZX² color 71H20 high chromaticG2330052016-10-05
EDDIG520200001DD Bio ZW iso color98H10 2000G520200002016-10-05
EDDIG52050001DD Bio ZW iso color98H10 500G52050002016-10-05
EDDIG52080001DD Bio ZW iso color98H10 800G52080002016-10-05

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07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
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08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
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