Identity
- Trade Name
- Tuxedo FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR FDA UDI
- Model / Reference
- Size 2 Replacement (A-Series) FDA UDI
- Description
- Tuxedo Intraoral Sensor Size 2 (6101A Replacement) PN 6101AR FDA UDI
Identifiers
- Catalog Number
- 6101AR FDA UDI
- Primary DI / UDI-DI
- 07540201000247 FDA UDI
- 510(k) Number
- K153710 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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: Dental digital imaging sensor, intraoral
Tuxedo by Led Dental, Inc. — 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
K153710 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Led Dental, Inc.
Sources (1)
- FDA UDI 673e64c4-d184-4e5c-8d88-d82c61cfd610 35 fields · synced May 30, 2026