Smileset Rechargeable Ultrasonic Cleaner – White

FDA UDI

Class I (US FDA UDI)

by Ortho Dental Lab, Llc

Identity

Trade Name: Smileset Rechargeable Ultrasonic Cleaner – White FDA UDI
Generic Name: Ultraviolet device microbial reduction unit FDA UDI
Device Name: SmileSet Rechargeable Ultrasonic Cleaner + UV Sanitizer – White FDA UDI
Model / Reference: 150-0116 FDA UDI
Description: SmileSet Rechargeable Ultrasonic Cleaner + UV Sanitizer – White FDA UDI

Identifiers

Primary DI / UDI-DI: 00850078989079 FDA UDI
FDA Product Code: NOB FDA UDI
FLG FDA UDI
GMDN Term: Ultraviolet device microbial reduction unit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6855 FDA UDI
880.6150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic appliance automated cleaner Ultraviolet device microbial reduction unit

Smileset Rechargeable Ultrasonic Cleaner – White by Ortho Dental Lab, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ultraviolet device microbial reduction unit.

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LightStrike+ — Xenex Disinfection Services, Inc. · Class II
SmileSet Rechargeable Ultrasonic Cleaner - Black — ORTHO DENTAL LAB, LLC · Class I
SmileSet QX105 Ultrasonic Cleaner - Mint — ORTHO DENTAL LAB, LLC · Class I
SmileSet QX105 Ultrasonic Cleaner - Black — ORTHO DENTAL LAB, LLC · Class I
Smileset Rechargeable Ultrasonic Cleaner – Mint — ORTHO DENTAL LAB, LLC · Class I
SmileSet QX105 Ultrasonic Cleaner - White — ORTHO DENTAL LAB, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ortho Dental Lab, Llc

Sources (1)

FDA UDI fd787544-1199-43b1-aa3f-50c698879161 34 fields · synced May 30, 2026