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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
330E HIGHSPEED HANDPIECE, 4H FDA UDI
Model / Reference
330E FDA UDI
Description
330E HIGHSPEED HANDPIECE, 4H FDA UDI

Identifiers

Catalog Number
10004 FDA UDI
Primary DI / UDI-DI
D950100040 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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 2dd59822-9e1d-4fb1-9c4e-531f14e43c2c 37 fields · synced Jun 1, 2026