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X-Cube

FDA UDI

Class I (US FDA UDI)

by Saeshin Precision Co., Ltd.

Identity

Trade Name
X-CUBE FDA UDI
Generic Name
Dental power tool system, line-powered FDA UDI
Model / Reference
ACL(B)-43I FDA UDI

Identifiers

Primary DI / UDI-DI
08809260470446 FDA UDI
510(k) Number
K092412 FDA UDI
FDA Product Code
EFA FDA UDI
GMDN Term
Dental power tool system, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental power tool system, line-powered

X-Cube by Saeshin Precision Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool system, line-powered.

Cleared under the same submission

K092412 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Saeshin Precision Co., Ltd.

Sources (1)

  • FDA UDI f1f20b13-e3ca-4ea6-84cf-75a966daba53 33 fields · synced May 30, 2026