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SH29S/LVS/MCS8 assy.

FDA UDI

Class I (US FDA UDI)

by Osada Electric Co., Ltd.

Identity

Trade Name
SH29S/LVS/MCS8 assy. FDA UDI
Generic Name
Dental power tool system handpiece, remotely-driven FDA UDI
Model / Reference
SH29S/LVS/MCS8 FDA UDI

Identifiers

Catalog Number
51752 FDA UDI
Primary DI / UDI-DI
04582227407306 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental power tool system handpiece, remotely-driven 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

Yes

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

Category: Dental power tool system handpiece, remotely-drivenRemotely-driven dental drilling system motorLine-powered dental drilling/sawing system handpieceRemotely-driven surgical/dental system drive cable

SH29S/LVS/MCS8 assy. by Osada Electric Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Remotely-driven surgical/dental system drive cable.

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 adfc44ee-2619-4d30-b1af-6ee5f13bc8f2 33 fields · synced May 31, 2026