FDA.reportPublic FDA data

DD Bio ZX² monolith zero

Primary DI
EDDILZD0521
Brand
DD Bio ZX² monolith zero
Company
Dental Direkt GmbH
Model
A2
Catalog number
LZD052
Device description
DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations.
Published
2016-10-05
Public version status
Update
Distribution status
Not 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
K150196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150196000DD cubeX2Dental Direkt GmbH2015-03-26EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDDILZD0521PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis dyeA colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36030Colour Liquid Prettau B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA37020Colour Liquid Prettau B2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28