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Smoothdrive

FDA UDI

Class I (US FDA UDI)

by Lares Research, Inc.

Identity

Trade Name
Smoothdrive FDA UDI
Generic Name
Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name
Smoothdrive 1:1 contra angle dental handpiece FDA UDI
Model / Reference
1:1 Contra Angle FDA UDI
Description
Smoothdrive 1:1 contra angle dental handpiece FDA UDI

Identifiers

Catalog Number
13503 FDA UDI
Primary DI / UDI-DI
D950135030 FDA UDI
510(k) Number
K202786 FDA UDI
FDA Product Code
EGS FDA UDI
GMDN Term
Dental surgical power tool motorized handpiece/set, electric 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

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

Category: Dental surgical power tool motorized handpiece/set, electric

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

Similar devices

Also classified as Dental surgical power tool motorized handpiece/set, electric.

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 5eee1136-7c06-4009-a4a3-a5852a48a800 36 fields · synced Jun 7, 2026