TERA HARZ SG NONE

GUDID 08800142100307

TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of surgical guide 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.

Dental appliance fabrication material, resin
Primary Device ID08800142100307
NIH Device Record Key06e7f124-7e92-4128-a087-7c38495f2aca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTERA HARZ SG
Version Model NumberSG-100
Catalog NumberNONE
Company DUNS694827880
Company NameGraphy Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800142100307 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-17
Device Publish Date2024-05-09

Devices Manufactured by Graphy Inc.

08800142100109 - TERA HARZ2024-05-17 TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The
08800142100116 - TERA HARZ2024-05-17 TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The
08800142100123 - TERA HARZ2024-05-17 TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed
08800142100208 - TERA HARZ CLEAR2024-05-17 TERA HARZ CLEAR is intended for the correction of dental malocclusion in patients with permanent dentition. The TERA HARZ CLEAR
08800142100307 - TERA HARZ SG2024-05-17TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of surgical guide 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.
08800142100307 - TERA HARZ SG2024-05-17 TERA HARZ SG are intended to support the dentist or oral surgeon when drilling for placement of dental implants. Fabrication of
08800142100499 - TERA HARZ DENTURE2024-05-17 The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and b
08800142100512 - TERA HARZ DENTURE2024-05-17 The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and b
08800142100536 - TERA HARZ DENTURE2024-05-17 The TERA HARZ DENTURE is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and b
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