Tera Harz Sg
FDA UDIEUDAMEDClass I (US FDA UDI)
by Graphy Inc.
Identity
- Trade Name
- TERA HARZ SG EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- TERA HARZ SG EUDAMEDTERA 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. FDA UDI
- Model / Reference
- SG-100 EUDAMEDFDA UDInone EUDAMED
- 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 dental Hospital requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. FDA UDI
Identifiers
- Catalog Number
- NONE FDA UDI
- Primary DI / UDI-DI
- 08800142100307 EUDAMEDFDA UDI
- Basic UDI-DI
- 088001421SG-100P5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, resin
Tera Harz Sg by Graphy Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Graphy Inc.
Sources (2)
- FDA UDI 06e7f124-7e92-4128-a087-7c38495f2aca 34 fields · synced Jul 22, 2026
- EUDAMED 76bbb934-32d1-48a4-8a57-cc89d8b8d30f 61 fields · synced Jul 22, 2026