GRAPHY SMA, INC

Matched from indexed company URL: Graphy, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		GRAPHY SMA, INC	5	Y	2026-01-01	601 Heritage Drive 127/128 Jupiter FL US 33458

PMN#

TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-C
2025-11-21
Graphy, Inc.
TERA HARZ CLEAR
2024-03-05
Graphy, Inc.
TERA HARZ II
2023-11-01
Graphy, Inc.
Tera Harz Clear
2022-11-03
Graphy Inc.
TERA HARZ DENTURE
2022-08-11
Graphy Inc.
TERA HARZ
2021-07-15
Graphy Inc.

GUDID#

Tera Tainer - Tera Tainer can be used in combination with all laser and DLP,SLA and LCD based 3D printers which support dental materials.Tera TainerR 3D-printing material is a preformed tooth positioner and retainer after orthodontic plan finished. indicated for the manufacturing of orthodontic retainer. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization.3D printer is not included with the device.
Graphy Inc.
2026-05-14
TERA HARZ CLEAR - "TERA HARZ CLEAR is available in two forms: (1) a light-curable, methacrylate-based photopolymer resin (marketed as ""Tera Harz Clear"") intended for the fabrication of orthodontic aligners; and (2) a finished device form, a clear orthodontic aligner (marketed as ""Shape Memory Aligner""), manufactured from the resin.The finished aligner is intended for the correction of dental malocclusion in patients with permanent dentition by applying continuous gentle force to move teeth."
Graphy Inc.
2024-05-09
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ HARD DENTURE - The TERA HARZ HARD DENTURE is a light-cured, methacrylate-based resin commonly used in additive manufacturing when producing dental structures (both full and partial dentures-Hard type).Methacrylate-based resin is a known material that is often used in the dental industry for fixed and removable prosthetic devices due to its physical-chemical, mechanical, and biocompatible properties.
Graphy Inc.
2025-12-03
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ II - TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
TERA HARZ DENTURE - The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with the TERA HARZ DENTURE requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on digital impression, stereolithographic additive printer, and curing light equipment.
Graphy Inc.
2024-05-09
Tera Harz Guard - TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit.
Graphy Inc.
2025-07-18
TERA HARZ CLEAR - TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR is intended for teeth movement by way of continuous gentle force. Fabrication of orthodontic aligner in dental Hospital requires a computer-aided and manufacturing (CAD/CAM) system that includes the following; scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ SG - TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of surgical guide in dentalHospital requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cureunit.
Graphy Inc.
2024-05-09
TERA HARZ CLEAR - TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR is intended for teeth movement by way of continuous gentle force. Fabrication of orthodontic aligner in dental Hospital requires a computer-aided and manufacturing (CAD/CAM) system that includes the following; scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09
TERA HARZ - TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed crown and bridge bases in dental laboratories. Fabrication of these prostheses require a manufacturing of all laser and DLP based 3D printers.
Graphy Inc.
2024-05-09
TERA HARZ - TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusalsurfaces.The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays,onlays, veneers and full crown restorations.Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes thefollowing: scanner, design software, additive printer, and post-cure unit
Graphy Inc.
2024-05-09
TERA HARZ - TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusalsurfaces.The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays,onlays, veneers and full crown restorations.Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
Graphy Inc.
2024-05-09