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Sh31

FDA UDI

Class I (US FDA UDI)

by Osada Electric Co., Ltd.

Identity

Trade Name
SH31 FDA UDI
Generic Name
Line-powered dental drilling/sawing system handpiece FDA UDI
Model / Reference
SH31 FDA UDI

Identifiers

Catalog Number
71663 FDA UDI
Primary DI / UDI-DI
04582227341952 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Line-powered dental drilling/sawing system handpiece 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 handpiece, remotely-drivenLine-powered dental drilling/sawing system handpiece

Sh31 by Osada Electric Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Line-powered dental drilling/sawing system handpiece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osada Electric Co., Ltd.

Sources (1)

  • FDA UDI b89c5d2a-4d69-448d-804c-01246b9e674e 33 fields · synced May 30, 2026