Identity
- Trade Name
- Midmark Intraoral Digital Sensor FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Model / Reference
- XSVS-08 FDA UDI
Identifiers
- Catalog Number
- XSVS-08 FDA UDI
- Primary DI / UDI-DI
- 00841709121166 FDA UDI
- 510(k) Number
- K112380 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral 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
Yes
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: Dental digital imaging sensor, intraoral
Midmark Intraoral Digital Sensor by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental digital imaging sensor, intraoral.
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- XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
- SCHICK33 — SIRONA DENTAL, INC. · Class II
- XIOS XG WIFI — SIRONA DENTAL, INC. · Class II
Cleared under the same submission
K112380 also covers:
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System — Midmark Corporation
- Midmark ClearVision Digital Sensor System with Laptop — Midmark Corporation
- Midmark ClearVision Digital Sensor System with Laptop — 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 b2e075e3-7aca-463a-a5d6-f60571f60640 35 fields · synced Jun 8, 2026