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SSH saggittal saw HP

FDA UDI

Class II (US FDA UDI)

by Osada Electric Co., Ltd.

Identity

Trade Name
SSH saggittal saw HP FDA UDI
Generic Name
Surgical power tool system handpiece, sawing, line-powered FDA UDI
Model / Reference
SSH FDA UDI

Identifiers

Catalog Number
75418 FDA UDI
Primary DI / UDI-DI
04582227427458 FDA UDI
510(k) Number
K935443 FDA UDI
FDA Product Code
DZH FDA UDI
GMDN Term
Surgical power tool system handpiece, sawing, line-powered 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

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

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: Sawing power tool attachment, sagittalSurgical power tool system handpiece, sawing, line-poweredDental power tool system handpiece, remotely-drivenLine-powered dental drilling/sawing system handpiece

SSH saggittal saw HP by Osada Electric Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K935443 also covers:

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 3ced3416-3292-4302-ac2b-5cc6e5bf100e 34 fields · synced Jun 6, 2026