Identity
- Trade Name
- DX-42 BITE CHEX FDA UDI
- Generic Name
- Dental x-ray film, non-screen FDA UDI
- Device Name
- D Speed, Size 3, 100 Single Film Paper Packets FDA UDI
- Model / Reference
- 18060 FDA UDI
- Description
- D Speed, Size 3, 100 Single Film Paper Packets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812045030634 FDA UDI
- FDA Product Code
- IWZ FDA UDI
- GMDN Term
- Dental x-ray film, non-screen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1840 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
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
Category: Dental x-ray film, non-screen
Dx-42 Bite Chex by Flow X-Ray Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray film, non-screen.
- INSIGHT — CARESTREAM HEALTH, INC. · Class I
- D-Speed — CARESTREAM HEALTH, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- D-Speed — CARESTREAM HEALTH, INC. · Class I
- Ultra-speed — CARESTREAM HEALTH, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, 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
- Flow X-Ray Corp.
Sources (1)
- FDA UDI 45a80f26-e639-4944-9c82-07170b65e769 33 fields · synced May 30, 2026