Isolite, i2

FDA UDI

Class I (US FDA UDI)

by Zyris, Inc.

Identity

Trade Name: Isolite, i2 FDA UDI
Generic Name: Dental suction system FDA UDI
Device Name: Isolite 2 ; Isodry Anterior Adapter Kit FDA UDI
Model / Reference: PIL0213 FDA UDI
Description: Isolite 2 ; Isodry Anterior Adapter Kit FDA UDI

Identifiers

Catalog Number: PIL0213 FDA UDI
Primary DI / UDI-DI: 00810032660758 FDA UDI
FDA Product Code: EBR FDA UDI
GMDN Term: Dental suction system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental suction system

Isolite, i2 by Zyris, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Zyris, Inc.

Sources (1)

FDA UDI 12bf143e-8e8b-4b84-add5-6e4d829a7eb1 35 fields · synced Jun 1, 2026