FDA.reportPublic FDA data

TERA HARZ SG

Primary DI
08800142100307
Brand
TERA HARZ SG
Company
Graphy Inc.
Model
SG-100
Catalog number
NONE
Device description
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.
Published
2024-05-09
Public version status
New
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800142100307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800142100307088001421003078800142100307

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800142100963TERA HARZ CLEARTA-28(Hyaligner)NONE2026-08-21
08800142100987TERA HARZ CLEARHyaligner2026-08-21
08800142100994TERA HARZ CLEARTR-07(Hyaligner)NONE2026-08-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14