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Young

FDA UDI

Class I (US FDA UDI)

by Young Dental Manufacturing I, Llc

Identity

Trade Name
Young FDA UDI
Generic Name
Dental laboratory power tool system FDA UDI
Device Name
Young INFINITY Cordless Handpiece System FDA UDI
Model / Reference
295737 FDA UDI
Description
Young INFINITY Cordless Handpiece System FDA UDI

Identifiers

Catalog Number
295737 FDA UDI
Primary DI / UDI-DI
00302732957370 FDA UDI
510(k) Number
K171377 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental laboratory power tool system 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental laboratory power tool system

Young by Young Dental Manufacturing I, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental laboratory power tool system.

Cleared under the same submission

K171377 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Young Dental Manufacturing I, Llc

Sources (1)

  • FDA UDI f7d05d46-964e-4f5d-8fb5-594b3993c545 37 fields · synced Jun 6, 2026