← Back to catalogue

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
Device Name
Angle Handpiece FDA UDI
Model / Reference
ACL(B)-01C FDA UDI
Description
Angle Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
08809260470347 FDA UDI
510(k) Number
K100192 FDA UDI
FDA Product Code
EGS 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

K100192 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Saeshin Precision Co., Ltd.

Sources (1)

  • FDA UDI 4966e91b-8d27-4602-9a9d-1ca046f32361 34 fields · synced May 30, 2026