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Isolite Moutpiece

FDA UDI

Class I (US FDA UDI)

by Zyris, Inc.

Identity

Trade Name
Isolite Moutpiece FDA UDI
Generic Name
Hand-held dental retractor FDA UDI
Device Name
Mouthpiece, Bulk (100), Medium FDA UDI
Model / Reference
CIL0703 FDA UDI
Description
Mouthpiece, Bulk (100), Medium FDA UDI

Identifiers

Catalog Number
CIL0703 FDA UDI
Primary DI / UDI-DI
00810032660161 FDA UDI
FDA Product Code
DYN FDA UDI
EIF FDA UDI
GMDN Term
Hand-held dental retractor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
872.4565 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held dental retractorDental suction protective mouthpiece

Isolite Moutpiece 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 47672aea-a4f7-4a4a-bcc5-8f3db62c8936 36 fields · synced Jun 6, 2026