Identity
- Trade Name
- ArgenZ HT+ 98x12 ML C1B FDA UDI
- Generic Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Device Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Model / Reference
- 130302 FDA UDI
- Description
- Dental porcelain/ceramic restoration kit FDA UDI
Identifiers
- Catalog Number
- 130302 FDA UDI
- Primary DI / UDI-DI
- D818130302 FDA UDI
- 510(k) Number
- K190079 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental porcelain/ceramic restoration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental porcelain/ceramic restoration kit
ArgenZ HT+ 98x12 ML C1B by Argen Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190079 also covers:
- ArgenZ HT+ 95x10 B4 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x12 B1 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x12 C3 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x12 OM1 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x12 OM2 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x18 A1 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x18 A4 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x18 B1 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x18 D3 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x18 OM2 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x20 A4 — ARGEN CORPORATION, THE
- ArgenZ HT+ 95x20 C1 — ARGEN CORPORATION, THE
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 |
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Manufacturer
- Manufacturer
- Argen Corporation, The
Sources (1)
- FDA UDI 00ef7549-75a1-4538-8c93-1f4499ae7a03 36 fields · synced Jun 8, 2026