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Torqtech

FDA UDI

Class I (US FDA UDI)

by J.morita Mfg.corp.

Identity

Trade Name
TORQTECH FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name
Attachments for Air and Electric Motors FDA UDI
Model / Reference
CA-5IF-O FDA UDI
Description
Attachments for Air and Electric Motors FDA UDI

Identifiers

Primary DI / UDI-DI
04548213016556 FDA UDI
510(k) Number
K103697 FDA UDI
FDA Product Code
EGS FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, electric 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

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Torqtech by J.morita Mfg.corp. — Class I — 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

K103697 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
J.morita Mfg.corp.

Sources (1)

  • FDA UDI 26ae8f48-302d-48b7-9d79-3e800db726bb 35 fields · synced May 30, 2026