FDA.reportPublic FDA data

Z-CAD Surface liquid

Primary DI
EMET4119970
Brand
Z-CAD Surface liquid
Company
Metoxit AG
Model
411997
Catalog number
411997
Device description
Z-CAD Surface liquid 100ml orange
Published
2022-05-03
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170050000Z-CAD smileMetoxit AG2018-08-23EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMET4119970PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481080828
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
EMET4097900Z-CAD CAM Blank4097904097902022-05-03
EMET4119500Z-CAD Deep liquid 4119504119502022-05-03
EMET4119510Z-CAD Deep liquid 4119514119512022-05-03
EMET4119520Z-CAD Deep liquid 4119524119522022-05-03
EMET4119530Z-CAD Deep liquid 4119534119532022-05-03
EMET4119540Z-CAD Deep liquid 4119544119542022-05-03
EMET4119550Z-CAD Deep liquid 4119554119552022-05-03
EMET4119560Z-CAD Deep liquid 4119564119562022-05-03
EMET4119570Z-CAD Deep liquid 4119574119572022-05-03
EMET4119580Z-CAD Deep liquid 4119584119582022-05-03
EMET4119590Z-CAD Deep liquid 4119594119592022-05-03
EMET4119600Z-CAD Deep liquid 4119604119602022-05-03
EMET4119610Z-CAD Deep liquid 4119614119612022-05-03
EMET4119620Z-CAD Deep liquid 4119624119622022-05-03
EMET4119630Z-CAD Deep liquid 4119634119632022-05-03
EMET4119640Z-CAD Deep liquid 4119644119642022-05-03
EMET4119650Z-CAD Deep liquid 4119654119652022-05-03
EMET4119660Z-CAD Deep liquid 4119664119662022-05-03
EMET4119670Z-CAD Deep liquid 4119674119672022-05-03
EMET4119680Z-CAD Deep liquid 4119684119682022-05-03

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