Identity
- Trade Name
- OrthoFX FDA UDI
- Generic Name
- Wax dental impression material FDA UDI
- Device Name
- Boil and Bite Home Impression Kit. FDA UDI
- Model / Reference
- BB HIK FDA UDI
- Description
- Boil and Bite Home Impression Kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003321775 FDA UDI
- FDA Product Code
- EHY FDA UDIEGD FDA UDI
- GMDN Term
- Wax dental impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI872.6890 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression tray, single-useWax dental impression material
OrthoFX by Orthofx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wax dental impression material.
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- ALMORE POWDERED WAX (9 GM) — Hager Worldwide, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Orthofx
Sources (1)
- FDA UDI 189308a7-8ca2-4a2f-bfd5-1eb0c00a0ebb 33 fields · synced Jun 8, 2026