Stratasys TrueDent
Stratasys Ltd
STRATASYS LTD - Headquarter
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017374693 | 3017374693 | STRATASYS LTD - Headquarter | 1 | N | 2026-01-01 | 1 Holtzman street Rehovot Central IL 7670401 |
| 3035364036 | 3035364036 | STRATASYS INC. | 1 | Y | 2026-01-01 | 5995 Opus Pkwy Minnetonka MN US 55343 |
| 3011350716 | 3011350716 | STRATASYS DIRECT MANUFACTURING | 1 | N | 2020-04-25 | 815 Kirkley Blvd Belton TX US 76513 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 311700 | 1990994584 | K220771 | Stratasys TrueDent | EBI | 2022-07-07 |
| 188205 | 1708434009 | ||||
| 311700 | 1378317880 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EBI | 1 | 2022-07-07 |
PMN#
GUDID#
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610-DSG - MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.
2025-09-09
MED610 - MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
2024-01-10
MED610 - MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
2024-01-10
MED610 - MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
2024-01-10
MED610 - MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
2024-01-10
MED610 - MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays.MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose.MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity.
2024-01-10
TrueDent - 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.
2023-03-06
TrueDent - 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.
2023-03-06
TrueDent - 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.
2023-03-06
TrueDent - 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.
2023-03-06
TrueDent - 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.
2023-03-06