FDA.reportPublic FDA data

Tetric CAD

Primary DI
07630243652358
Brand
Tetric CAD
Company
Dent4You AG
Model
692167
Catalog number
692167
Device description
Tetric CAD for PlanMill HT A1 C14/5
Published
2026-02-10
Public version status
New
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630243652358PrimaryGS10
07630243651832Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630243652358076302436523587630243652358
07630243651832076302436518327630243651832

GMDN Terms#

Term, Definition table
TermDefinition
Resin dental inlayA custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.

Regulatory Flags#

DUNS number
480152811
Device count
5
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
07630392901437Coltolux Comfort600343932023-02-01
07630392901444Coltolux Comfort600343942023-02-01
07630392901451Coltolux Comfort600343952023-02-01
07630392901468Coltolux Comfort600343962023-02-01
07630392901406Coltolux Comfort600343902023-02-01
07630392901413Coltolux Comfort600343912023-02-01
07630392901420Coltolux Comfort600343922023-02-01
07630243660995Alpen Diamonds60032007600320072026-09-04
07630243661237Alpen Diamonds60032031600320312026-09-04
07630243662470Alpen Diamonds60032155600321552026-09-04
07630243662494Alpen Diamonds60032157600321572026-09-04
07630243662517Alpen Diamonds60032159600321592026-09-04
07630243662531Alpen Diamonds60032161600321612026-09-04
07630243662555Alpen Diamonds60032163600321632026-09-04
07630243662579Alpen Diamonds60032165600321652026-09-04
07630243662593Alpen Diamonds60032167600321672026-09-04
07630243662616Alpen Diamonds60032169600321692026-09-04
07630243662630Alpen Diamonds60032171600321712026-09-04
07630243662654Alpen Diamonds60032173600321732026-09-04
07630243662678Alpen Diamonds60032175600321752026-09-04

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Primary DI, Brand, Company table
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00195062160493Build-It FRKerr CorporationEBF2026-10-27
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06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25