Identity
- Trade Name
- HI-I® FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Special Fibered #52 HI-I® Pour FDA UDI
- Model / Reference
- 13045-006 FDA UDI
- Description
- Special Fibered #52 HI-I® Pour FDA UDI
Identifiers
- Catalog Number
- 13045-006 FDA UDI
- Primary DI / UDI-DI
- B715130450060 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 145 Gram FDA UDI
Category: Dental appliance fabrication material, resin
Hi-I® by Fricke International, 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
- Fricke International, Inc.
Sources (1)
- FDA UDI 4d2f4966-3ea3-495c-9b61-03d542f95937 36 fields · synced May 31, 2026