Tera Harz Guard
FDA UDIEUDAMEDClass I (US FDA UDI)
by Graphy Inc.
Identity
- Trade Name
- Tera Harz Guard EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- TERA HARZ GUARD EUDAMEDTERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit. FDA UDI
- Model / Reference
- TE-151 EUDAMEDFDA UDInone EUDAMED
- Description
- TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800142100949 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001421TERAHARZGUARDSE EUDAMED
- Direct Marketing DI
- 08800142100949 EUDAMED
- FDA Product Code
- BRW FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5820 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
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, resin
Tera Harz Guard 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 86898d10-c1d3-4d78-9b93-41c5823a9c36 34 fields · synced Jul 22, 2026
- EUDAMED f48e9b17-f5e2-47bb-bfc8-c6828314edc7 61 fields · synced Jul 22, 2026