Astek

FDA UDI

Class I (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name: Astek FDA UDI
Generic Name: Dental impression material syringe, reusable FDA UDI
Device Name: Mouth Prop - Assorted Unodent FDA UDI
Model / Reference: 16499UNODENT FDA UDI
Description: Mouth Prop - Assorted Unodent FDA UDI

Identifiers

Primary DI / UDI-DI: 00840326423776 FDA UDI
FDA Product Code: EIG FDA UDI
GMDN Term: Dental impression material syringe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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: Dental impression material syringe, reusable

Astek by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MASTER-DENT — DENTONICS, INC.
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easy2 impression syringe pink — DETAX GmbH · Class I
Mixing tips brown, short — DETAX GmbH · 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: Young Innovations, Inc.

Sources (1)

FDA UDI daf94ed3-2424-42a1-812e-a017d128660a 34 fields · synced May 30, 2026