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Varios

FDA UDI

Class II (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name
Varios FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Model / Reference
E7 FDA UDI

Identifiers

Primary DI / UDI-DI
04560264563377 FDA UDI
510(k) Number
K113530 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Varios by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, endodontic.

Cleared under the same submission

K113530 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nakanishi Inc.

Sources (1)

  • FDA UDI e1870923-1e8c-497a-956a-d507c446daf8 33 fields · synced May 30, 2026