Temptation® 10L Syringe Mixing Tips

FDA UDI

Class I (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Temptation® 10L Syringe Mixing Tips FDA UDI
Generic Name: Dental material mixing nozzle FDA UDI
Device Name: Dental material mixing nozzle, non-sterile FDA UDI
Model / Reference: 153251 FDA UDI
Description: Dental material mixing nozzle, non-sterile FDA UDI

Identifiers

Catalog Number: 153251 FDA UDI
Primary DI / UDI-DI: 00359883004019 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental material mixing nozzle

Temptation® 10L Syringe Mixing Tips by Den-Mat Holdings, LLC — 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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RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
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
Protemp™ Plus — 3M Deutschland 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: Den-Mat Holdings, LLC

Sources (1)

FDA UDI db2947cb-6cb0-405b-82e6-dfab5203dd06 36 fields · synced Jun 9, 2026