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TrueDent Cyan
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref OBJ-09165510(k) K220771
Identity
- Trade Name
- TrueDent Cyan EUDAMEDTrueDent FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- TrueDent EUDAMEDStratasys 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. FDA UDI
- Model / Reference
- OBJ-09165 EUDAMEDTrueDent Cyan FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018915400 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018915TrueDentRB EUDAMED
- 510(k) Number
- K220771 FDA UDI
- FDA Product Code
- EBI FDA UDIEBG FDA UDIEBF FDA UDIPZY FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3770 FDA UDI872.3690 FDA UDI872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TrueDent Cyan by Stratasys Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220771 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7290018915TrueDentRB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Stratasys Ltd.
- EUDAMED SRN
- IL-MF-000040298
- FDA Applicant
- Stratasys, Ltd.
- Authorised Representative
- Stratasys GmbH DE-AR-000039118
Sources (3)
- EUDAMED 190f3e3a-af22-417d-9ec5-0d48aa855748 85 fields · synced Jun 19, 2026
- FDA UDI abc48595-8249-47c3-a873-fee22ec9790a 35 fields · synced May 30, 2026
- FDA 510(k) K220771 1 fields · synced May 18, 2026