Identity
- Trade Name
- Blu FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure. FDA UDI
- Model / Reference
- Size 1 FDA UDI
- Description
- Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure. FDA UDI
Identifiers
- Catalog Number
- IS028-DL FDA UDI
- Primary DI / UDI-DI
- 08055060430405 FDA UDI
- 510(k) Number
- K200625 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
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
Dimensions & Sizes
- Size
- Width — 25.4 Millimeter FDA UDILength — 36.8 Millimeter FDA UDIHeight — 4.8 Millimeter FDA UDI
Category: Dental digital imaging sensor, intraoral
Blu by Trident Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental digital imaging sensor, intraoral.
- DC-Air™ Intraoral Sensor — Athlos Oy · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Schick — Dentsply International · Class II
- XIOS XG SELECT — SIRONA DENTAL, INC. · Class II
- CDR — SIRONA DENTAL, INC. · Class II
- 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
K200625 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
- Trident Srl
Sources (1)
- FDA UDI 5a971e00-8a03-42b7-90be-1d175f4096c0 38 fields · synced Jun 1, 2026