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Lares Research

FDA UDI

Class I (US FDA UDI)

by Lares Research, Inc.

Identity

Trade Name
Lares Research FDA UDI
Generic Name
Pneumatic dental scaling/debridement system handpiece FDA UDI
Device Name
High-speed Handpiece, Kent Dental Turbine Plus Mini, Push button FDA UDI
Model / Reference
Kent Dental 557 ProStyle SF SLC FDA UDI
Description
High-speed Handpiece, Kent Dental Turbine Plus Mini, Push button FDA UDI

Identifiers

Catalog Number
13683 FDA UDI
Primary DI / UDI-DI
D9501368303 FDA UDI
510(k) Number
K141221 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Pneumatic dental scaling/debridement system handpiece FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
Not 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

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

Dimensions & Sizes

Size
Length — 4.5 Inch FDA UDI

Lares Research by Lares Research, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141221 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lares Research, Inc.

Sources (1)

  • FDA UDI 47b9b6d7-1db2-4b8a-8883-0754b436175d 38 fields · synced Jun 8, 2026