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Pch-1

FDA UDI

Class I (US FDA UDI)

by Osada Electric Co., Ltd.

Identity

Trade Name
PCH-1 FDA UDI
Generic Name
Dental power tool system handpiece, remotely-driven FDA UDI
Model / Reference
PCH-1 FDA UDI

Identifiers

Catalog Number
56335 FDA UDI
Primary DI / UDI-DI
04580406869969 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

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

Pch-1 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 c05cca5c-e8c0-4bfc-8893-351eb64092ac 33 fields · synced May 30, 2026