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Isolite Mouthpiece

FDA UDI

Class I (US FDA UDI)

by Zyris, Inc.

Identity

Trade Name
Isolite Mouthpiece FDA UDI
Generic Name
Dental suction protective mouthpiece FDA UDI
Device Name
Customer Success Kit, OUS FDA UDI
Model / Reference
AIL0250 FDA UDI
Description
Customer Success Kit, OUS FDA UDI

Identifiers

Catalog Number
AIL0250 FDA UDI
Primary DI / UDI-DI
00810032661250 FDA UDI
FDA Product Code
EIF FDA UDI
DYN FDA UDI
GMDN Term
Dental suction protective mouthpiece FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held dental retractorDental suction protective mouthpiece

Isolite Mouthpiece by Zyris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental suction protective mouthpiece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zyris, Inc.

Sources (1)

  • FDA UDI 69bc5391-d1f9-4581-8b21-4390d6e492ae 36 fields · synced May 30, 2026