Identity
- Trade Name
- Dental Basics FDA UDI
- Generic Name
- Digital imaging cassette FDA UDI
- Device Name
- Phosphor Plate Barrier Envelopes, Size 2, Side Opening FDA UDI
- Model / Reference
- BE12 FDA UDI
- Description
- Phosphor Plate Barrier Envelopes, Size 2, Side Opening FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850061028044 FDA UDI
- 510(k) Number
- K163447 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Digital imaging cassette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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: Digital imaging cassette
Dental Basics by Dental Basics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Digital imaging cassette.
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- CARESTREAM CR Cassette — CARESTREAM HEALTH, INC. · Class I
- CR MD4.0T GENERAL CASSETTE — Agfa Corp. · Class II
- CR HD5.0S GENERAL CASSETTE — Agfa Corp. · Class II
Cleared under the same submission
K163447 also covers:
- SOLEIL — BENCO DENTAL SUPPLY CO.
- Dental Basics — Dental Basics Inc.
- Dental Basics — Dental Basics Inc.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
- PHOSPHOR PLATE BARRIER ENVELOPES — MAXILL, INC.
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
- Dental Basics Inc.
Sources (1)
- FDA UDI 91777c9a-ceb0-4073-bf85-1d25c52bffc1 34 fields · synced Jun 6, 2026