TrueDent

Primary DI
07290018915806
Brand
TrueDent
Company
STRATASYS LTD
Model
TrueDent Yellow
Device description
Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.Fabrication of dental appliances with Stratasys TrueDent™ requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, a Stratasys PolyJet 3D printer, and curing light equipment.
Published
2023-03-06
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
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220771000Stratasys TrueDentStratasys, Ltd.2022-07-07EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018915806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018915806072900189158067290018915806

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532091048
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018915844MED610-DSGMED610-DSG, 1KGOBJ-040782025-09-09
07290018915042MED610-DSGMED610-DSG, 1.1 KGOBJ-091932025-09-09
07290018915240MED610-DSGMED610-DSG, 3.6 KGOBJ-033852025-09-09
07290018915448MED610-DSGMED610-DSG, 4KGOBJ-182612025-09-09
07290018915646MED610-DSGMED610-DSG, 4KG (J5DentaJet) OBJ-120672025-09-09
07290018915837MED610-DSGMED610-DSG, 1KGOBJ-040782025-09-09
07290018915028MED610MED610 4kg (J5 DentaJet)OBJ-120672024-01-10
07290018915219MED610MED610 1KgOBJ-040782024-01-10
07290018915417MED610MED610 1.1KgOBJ-091932024-01-10
07290018915615MED610MED610 3.6KgOBJ-033852024-01-10
07290018915813MED610MED610 4KgOBJ-182612024-01-10
07290018915004TrueDent TrueDent ClearOBJ-091642023-03-06
07290018915202TrueDent TrueDent White2023-03-06
07290018915400TrueDent TrueDent Cyan2023-03-06
07290018915608TrueDent TrueDent Magenta2023-03-06

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Primary DI, Brand, Company table
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E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
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E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
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