FDA.reportPublic FDA data

DD Bio ZX² color

Primary DI
EDDIG59100601
Brand
DD Bio ZX² color
Company
Dental Direkt GmbH
Model
98H12 A2
Catalog number
G5910060
Device description
DD Bio ZX² are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio ZX² can be used for all dental constructions with up to two bridge elements in the front and side tooth area.
Published
2024-03-27
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142987000DD Bio Z, DD Bio ZX(square), DD BioZX(square) colorDental Direkt of Amerika UG (Haftungsbeschraenkt)2015-02-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDDIG59100601PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter
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
EDDI963011DD cubeY® HL98H20 A1963012026-06-02
EDDI963051DD cubeY® HL98H25 A1963052026-06-02
EDDI963061DD cubeY® HL98H20 A2963062026-06-02
EDDI963071DD cubeY® HL98H25 A2963072026-06-02
EDDI963081DD cubeY® HL98H20 A3963082026-06-02
EDDI963091DD cubeY® HL98H25 A3963092026-06-02
EDDI963161DD cubeY® HL98H20 A3.5963162026-06-02
EDDI963171DD cubeY® HL98H25 A3.5963172026-06-02
EDDI963431DD cubeY® HL98H20 B1963432026-06-02
EDDI963441DD cubeY® HL98H20 B2963442026-06-02
EDDI963451DD cubeY® HL98H20 C1963452026-06-02
EDDI963821DD cubeY® HL98H20 C2963822026-06-02
EDDI963831DD cubeY® HL98H20 D2963832026-06-02
EDDI963841DD cubeY® HL98H20 0M2963842026-06-02
EDDI963851DD cubeY® HL98H25 B1963852026-06-02
EDDI963861DD cubeY® HL98H25 B2963862026-06-02
EDDI963941DD cubeY® HL98H25 C1963942026-06-02
EDDI963951DD cubeY® HL98H25 C2963952026-06-02
EDDI963961DD cubeY® HL98H25 D2963962026-06-02
EDDI963971DD cubeY® HL98H25 0M2963972026-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
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