Identity
- Trade Name
- Gendex GXS-700™ intraoral sensor FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- Size 2 FDA UDI
- Model / Reference
- 1.010.7655 FDA UDI
- Description
- Size 2 FDA UDI
Identifiers
- Catalog Number
- 10107655 FDA UDI
- Primary DI / UDI-DI
- EKAV101076550 FDA UDI
- 510(k) Number
- K090458 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
No
FDA UDI
Category: Dental digital imaging sensor, intraoral
Gendex GXS-700™ intraoral sensor by Gendex Corp. — 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
K090458 also covers:
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- DEXIS Platinum™ intraoral sensor — DEXIS LLC
- Gendex GXS-700™ intraoral sensor — GENDEX CORP.
- Gendex GXS-700™ intraoral sensor — GENDEX CORP.
- Gendex GXS-700™ intraoral sensor — GENDEX CORP.
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
- Gendex Corp.
Sources (1)
- FDA UDI 7336d4a8-42c1-4174-9b35-456d24c4b7ac 37 fields · synced May 30, 2026