TERA HARZ II

GUDID 08800142100697

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.

Dental prosthesis veneer resin
Primary Device ID08800142100697
NIH Device Record Keycc8cbeed-3186-477f-ac96-3ead47191da7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTERA HARZ II
Version Model NumberBR-23B2
Company DUNS694827880
Company NameGraphy Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108800142100697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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

On-Brand Devices [TERA HARZ II]

08800142100895TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100871TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100857TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100833TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100819TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100796TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100772TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100758TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100734TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100710TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100697TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100673TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100659TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100635TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations
08800142100611TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations

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