Identity
- Trade Name
- Midmark PREVA IntraOral Dental X-ray System FDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- Intraoral X-ray Preva Tube Head With Oil FDA UDI
- Model / Reference
- 30-A1027 FDA UDI
- Description
- Intraoral X-ray Preva Tube Head With Oil FDA UDI
Identifiers
- Catalog Number
- 30-A1027 FDA UDI
- Primary DI / UDI-DI
- 00841709102523 FDA UDI
- 510(k) Number
- K043092 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- X-ray tube housing assembly, diagnostic 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray tube housing assembly, diagnostic
Midmark PREVA IntraOral Dental X-ray System by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K043092 also covers:
- CONTROL UNIT ASM., PREVA 2.0 RAL 9010 — Midmark Corporation
- CONTROL UNIT, PREVA 2.0 MOBILE STAND — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
- Midmark — Midmark Corporation
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
- Midmark Corporation
Sources (1)
- FDA UDI 024ded36-9b29-4f75-8ebd-d6cfc459ec8a 37 fields · synced Jun 8, 2026