NexTemp Tips

FDA UDI

Class I (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name: NexTemp Tips FDA UDI
Generic Name: Dental material mixing nozzle FDA UDI
Device Name: MIX TIPS & INTRAORAL TIPS (35) FDA UDI
Model / Reference: 3001417 FDA UDI
Description: MIX TIPS & INTRAORAL TIPS (35) FDA UDI

Identifiers

Primary DI / UDI-DI: 00348783003727 FDA UDI
FDA Product Code: KXR FDA UDI
GMDN Term: Dental material mixing nozzle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental material mixing nozzle

NexTemp Tips by Premier Dental Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material mixing nozzle.

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3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
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BENCO — BENCO DENTAL SUPPLY CO. · Class I
Imprint™ 4 Regular — 3M Deutschland GmbH · Class II
Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
#1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
Plasdent — PLASDENT CORP. · 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: Premier Dental Products Company

Sources (1)

FDA UDI 8d04f408-655f-4ff7-8b08-48e55b55c862 33 fields · synced May 30, 2026