Identity
- Trade Name
- AmalgamBond® FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Measuring Spoons, 2 mixing wells) FDA UDI
- Model / Reference
- S375 FDA UDI
- Description
- Accessory Kit AmalgamBond®: (1-Brush Handle, 100- Disposable Brush Tips, 1-Spatula, 3-Measuring Spoons, 2 mixing wells) FDA UDI
Identifiers
- Catalog Number
- S375 FDA UDI
- Primary DI / UDI-DI
- 00810000529049 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material application tool, single-use
AmalgamBond® by Parkell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Parkell, Inc.
Sources (1)
- FDA UDI 705d50d9-6890-4157-9f5c-250a4f3d2b5d 35 fields · synced May 30, 2026