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
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
08800142100659TERA HARZ IIBR-23A3-1000NONE2024-05-09
08800142100673TERA HARZ IIBR-23B1-1000NONE2024-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03