FDA.reportPublic FDA data

TERA HARZ II

Primary DI
08800142100659
Brand
TERA HARZ II
Company
Graphy Inc.
Model
BR-23A3-1000
Catalog number
NONE
Device description
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.
Published
2024-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233502000TERA HARZ IIGraphy, Inc.2023-11-01EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800142100659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800142100659088001421006598800142100659

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis veneer resinA dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694827880
Device count
1
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800142101007Tera TainerTA-832026-05-14
08800142100925TERA HARZ CLEARTA-28NONE2024-05-09
08800142100406TERA HARZ HARD DENTURETHD-C-5002025-12-03
08800142100413TERA HARZ HARD DENTURETHD-C-10002025-12-03
08800142100420TERA HARZ HARD DENTURETHD-LP-5002025-12-03
08800142100437TERA HARZ HARD DENTURETHD-LP-10002025-12-03
08800142100444TERA HARZ HARD DENTURETHD-P-5002025-12-03
08800142100451TERA HARZ HARD DENTURETHD-P-10002025-12-03
08800142100468TERA HARZ HARD DENTURETHD-CP-5002025-12-03
08800142100475TERA HARZ HARD DENTURETHD-CP-10002025-12-03
08800142100499TERA HARZ DENTURETFDH-BP-1000NONE2024-05-09
08800142100512TERA HARZ DENTURETFDH-C-1000NONE2024-05-09
08800142100536TERA HARZ DENTURETFDH-W-1000NONE2024-05-09
08800142100550TERA HARZ DENTURETFDH-LP-1000NONE2024-05-09
08800142100574TERA HARZ DENTURETFDH-P-1000NONE2024-05-09
08800142100598TERA HARZ DENTURETFDH-DP-1000NONE2024-05-09
08800142100611TERA HARZ IIBR-23A1-1000NONE2024-05-09
08800142100635TERA HARZ IIBR-23A2-1000NONE2024-05-09
08800142100673TERA HARZ IIBR-23B1-1000NONE2024-05-09
08800142100697TERA HARZ IIBR-23B2-10002024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLMN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
00371347023398Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023404Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023411Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07