CediTEC DB

Primary DI
EDDI61951
Brand
CediTEC DB
Company
Dental Direkt GmbH
Model
Disc pink 30 mm
Catalog number
6195
Device description
CediTEC DB polymer milling blanks are intended for the fabrication of restorations.
Published
2024-01-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
EDDI61951PrimaryHIBCC0

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
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EPOLPMMP10150Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10180Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10190Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
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