Identity
- Trade Name
- GS80 FDA UDI
- Generic Name
- Dental amalgam alloy FDA UDI
- Device Name
- GS80 2SP SLOW 50 FDA UDI
- Model / Reference
- 4402404 FDA UDI
- Description
- GS80 2SP SLOW 50 FDA UDI
Identifiers
- Catalog Number
- 4402404 FDA UDI
- Primary DI / UDI-DI
- 09336472002763 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
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
Yes
FDA UDI
Category: Dental amalgam alloy
Gs80 by Sdi , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam alloy.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Vivid Alloy 3 Spill — PEARSON DENTAL SUPPLIES, INC. · Class II
- ADMIX AMALGAM — BENCO DENTAL SUPPLY CO. · Class II
- SPHERICAL AMALGAM — BENCO DENTAL SUPPLY CO. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Tytin FC — KERR CORPORATION · Class II
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.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- 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
- Sdi , Ltd.
Sources (1)
- FDA UDI b8ca79ba-1a44-4147-9f78-965f172d3e4f 36 fields · synced May 30, 2026