Identity
- Trade Name
- Panoramic FDA UDI
- Generic Name
- Dental x-ray film holder, reusable FDA UDI
- Device Name
- Panoramic Cassette Sleeves FDA UDI
- Model / Reference
- 00-20002NN FDA UDI
- Description
- Panoramic Cassette Sleeves FDA UDI
Identifiers
- Catalog Number
- 00-20002NN FDA UDI
- Primary DI / UDI-DI
- 00840326416020 FDA UDI
- 510(k) Number
- K043557 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Dental x-ray film holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental x-ray film holder, reusable
Panoramic by Young Innovations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental x-ray film holder, reusable.
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- TrollByte — Directa AB · Class I
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- CDR — SIRONA DENTAL, INC. · Class II
Cleared under the same submission
K043557 also covers:
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
- Young Innovations, Inc.
Sources (1)
- FDA UDI 05ee72f2-678c-46a3-a560-8c5a6a9b4908 36 fields · synced Jun 6, 2026