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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
557 ProStyle SF Lite Swivel fiber optic ceramic bearing FDA UDI
Model / Reference
557 ProStyle SF Lite FDA UDI
Description
557 ProStyle SF Lite Swivel fiber optic ceramic bearing FDA UDI

Identifiers

Catalog Number
13127-236U FDA UDI
Primary DI / UDI-DI
D95013124236U0 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

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 e6c5bc37-0a14-47d7-832a-26c499ea55af 37 fields · synced May 31, 2026