Identity
- Trade Name
- QH FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- Dental alloy restorations FDA UDI
- Model / Reference
- 1.0ozt FDA UDI
- Description
- Dental alloy restorations FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816795020518 FDA UDI
- FDA Product Code
- EJT FDA UDI
- GMDN Term
- Dental casting noble alloy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental casting noble alloy
Qh by Aurident Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting noble alloy.
- Harmony 2 — Ivoclar Vivadent, Inc. · Class II
- Harmony XH — Ivoclar Vivadent, Inc. · Class II
- Jensen Premium Dental Alloy — JENSEN INDUSTRIES, INC. · Class II
- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Aquarius — Ivoclar Vivadent, Inc. · Class II
- W 1 — Ivoclar Vivadent, Inc. · Class II
- Harmony Medium — Ivoclar Vivadent, Inc. · Class II
- ARGEDENT 51SF (5 dwt) — ARGEN CORPORATION, THE · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aurident Inc
Sources (1)
- FDA UDI a85a15f3-5370-4596-85c4-ff74506bde36 33 fields · synced May 29, 2026