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X-Sg93

FDA UDI

Class II (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name
X-SG93 FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Model / Reference
X-SG93 FDA UDI

Identifiers

Primary DI / UDI-DI
04589551382453 FDA UDI
510(k) Number
K211584 FDA UDI
FDA Product Code
KMW FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical power tool motorized handpiece/set, electric

X-Sg93 by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, electric.

Cleared under the same submission

K211584 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nakanishi Inc.

Sources (1)

  • FDA UDI c1adc12b-ec79-4dbe-b9f0-a8f32d2c1ee9 33 fields · synced Jun 8, 2026