Identity
- Trade Name
- DHPI Health-Tec Dental Amalgam Alloy FDA UDI
- Generic Name
- Dental amalgam FDA UDI
- Device Name
- DHPI Health Tec High Copper Spherical Triple Spill FDA UDI
- Model / Reference
- 100-UTT3500 FDA UDI
- Description
- DHPI Health Tec High Copper Spherical Triple Spill FDA UDI
Identifiers
- Catalog Number
- 100-UTT3500 FDA UDI
- Primary DI / UDI-DI
- D773100UTT35001 FDA UDI
- 510(k) Number
- K951865 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 800 Milligram FDA UDI
DHPI Health-Tec Dental Amalgam Alloy by Dental Health Products Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K951865 also covers:
- Formula-T Spherical Alloy — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 1 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 2 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Formula-T Spherical Alloy Fast Set 3 SPILL — DARBY DENTAL SUPPLY, LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
- Ultra High Copper Spherical — DMG America LLC
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
- Dental Health Products Inc
Sources (1)
- FDA UDI 74e4c797-a630-4dd7-827e-55989158c6fd 39 fields · synced Jun 1, 2026