FDA.reportPublic FDA data

DD Bio ZW iso color

Primary DI
EDDIG522C101
Brand
DD Bio ZW iso color
Company
Dental Direkt GmbH
Model
98H14 C1
Catalog number
G522C10
Device description
DD Bio Z are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD Bio Z can be used for all dental constructions with up to two bridge elements in the front and side tooth area.
Published
2019-11-05
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
EDDIG522C101PrimaryHIBCC0

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
Height14Millimeter
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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06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
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