Identity
- Trade Name
- Patterson® FDA UDI
- Generic Name
- Dental amalgam alloy FDA UDI
- Device Name
- ALLOY, AMALGAM FDA UDI
- Model / Reference
- 70830208 FDA UDI
- Description
- ALLOY, AMALGAM FDA UDI
Identifiers
- Catalog Number
- 70830208 FDA UDI
- Primary DI / UDI-DI
- D6620708302082 FDA UDI
- 510(k) Number
- K801639 FDA UDI
- FDA Product Code
- EJJ FDA UDI
- GMDN Term
- Dental amalgam alloy 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental amalgam alloy
Patterson® by Patterson Dental Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental amalgam alloy.
- PERMITE — Sdi , Ltd. · Class II
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- GS80 — Sdi , Ltd. · Class II
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Cleared under the same submission
K801639 also covers:
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- GS80 — Sdi , Ltd.
- GS80 — Sdi , Ltd.
- GS80 — Sdi , Ltd.
- GS80 — Sdi , Ltd.
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
- Patterson Dental Supply, Inc.
Sources (1)
- FDA UDI c52e4d67-639d-4fd4-b0a8-12a6ffcdaebd 35 fields · synced May 30, 2026