Identity
- Trade Name
- Universal Holders FDA UDI
- Generic Name
- Dental x-ray film holder, single-use FDA UDI
- Device Name
- Universal Bitewing Holder - Red FDA UDI
- Model / Reference
- B1073107 FDA UDI
- Description
- Universal Bitewing Holder - Red FDA UDI
Identifiers
- Primary DI / UDI-DI
- D764B10731071 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- GMDN Term
- Dental x-ray film holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.1905 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental x-ray film holder, single-use
Universal Holders by Sirona Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental x-ray film holder, single-use.
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- Steri-Shield — Steri-Shield Products, 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
- Sirona Dental, Inc.
Sources (1)
- FDA UDI 59dd3d2d-70f7-4e58-b8dd-861ac071df8c 34 fields · synced Jun 8, 2026