Identity
- Trade Name
- Wykalloy amalgam sample pack FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Model / Reference
- 75901 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853383006417 FDA UDI
- 510(k) Number
- K002808 FDA UDI
- FDA Product Code
- EJJ FDA UDI
- GMDN Term
- Dental amalgam FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3070 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental amalgam
Wykalloy amalgam sample pack by Wykle Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002808 also covers:
- ANA 2000 Capsules 1 Spill 450 count — WYKLE RESEARCH, INC.
- ANA 2000 Capsules 1 Spill 50 count — WYKLE RESEARCH, INC.
- ANA 2000 Capsules 2 Spill 450 count — WYKLE RESEARCH, INC.
- ANA 2000 Capsules 2 Spill 50 count — WYKLE RESEARCH, INC.
- ANA 2000 Capsules 3 Spill 50 count — WYKLE RESEARCH, INC.
- ANA 2000 Duett 200 — WYKLE RESEARCH, INC.
- ANA 2000 Duett 400 — WYKLE RESEARCH, INC.
- ANA 2000 Duett 50 — WYKLE RESEARCH, INC.
- ANA 2000 Powder 250g — WYKLE RESEARCH, INC.
- ANA 2000 Powder 30g — WYKLE RESEARCH, INC.
- ANA 2000 Powder 500g — WYKLE RESEARCH, INC.
- ANA 70 Duett 200 — WYKLE RESEARCH, INC.
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
- Wykle Research, Inc.
Sources (1)
- FDA UDI 0e95bf08-96d5-4389-a2a0-a7c95273dd1e 34 fields · synced May 30, 2026