Identity
- Trade Name
- COXO FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- Dental Implantation Systems FDA UDI
- Model / Reference
- C-Sailor Pro FDA UDI
- Description
- Dental Implantation Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974267891104 FDA UDI
- 510(k) Number
- K220831 FDA UDI
- FDA Product Code
- EBW FDA UDIEGS FDA UDIKMW FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI872.4120 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool system control unit, line-powered
Coxo by Foshan COXO Medical Instrument Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system control unit, line-powered.
- Set iOptima int-2xMX2-Light — Bien-Air Dental SA · Class I
- Console Optima MX2 INT — Bien-Air Dental SA · Class I
- Console iOptima — Bien-Air Dental SA · Class I
- AMADEO M-UK1023 — W & H Dentalwerk Bürmoos GmbH · Class II
- SET STUDENTS BAUSA 13 — Bien-Air Dental SA · Class I
- OSADA PEDO-30W — OSADA ELECTRIC CO., LTD. · Class I
- Set Optima INT MCX + B24-32V — Bien-Air Dental SA · Class I
- Set OSSEODUO + S120 — Bien-Air Surgery SA · Class II
Cleared under the same submission
K220831 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 6422a1dc-bfa8-48d9-bb88-8042e5548ea7 34 fields · synced May 30, 2026