Plasdent

FDA UDI

Class I (US FDA UDI)

by Plasdent Corp.

Identity

Trade Name: Plasdent FDA UDI
Generic Name: Mouth gag, non-adjustable FDA UDI
Device Name: Silicone Mouth Props, Medium (Child), Turquoise FDA UDI
Model / Reference: SC-9050-4T FDA UDI
Description: Silicone Mouth Props, Medium (Child), Turquoise FDA UDI

Identifiers

Catalog Number: SC-9050-4T FDA UDI
Primary DI / UDI-DI: D832SC90504T1 FDA UDI
FDA Product Code: NRD FDA UDI
GMDN Term: Mouth gag, non-adjustable 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Mouth gag, non-adjustable

Plasdent by Plasdent Corp. — 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: Plasdent Corp.

Sources (1)

FDA UDI af6c9375-4e6b-4bae-9e3d-356fad3c0482 34 fields · synced May 30, 2026