Tempolok Syringe Mixing tips 15 pcs

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: Tempolok Syringe Mixing tips 15 pcs FDA UDI
Generic Name: Dental material mixing nozzle FDA UDI
Device Name: Mixing tips that can be used from an auto-mix syringe for both Tempolok and Resiment Ready-Mix. FDA UDI
Model / Reference: 811918 FDA UDI
Description: Mixing tips that can be used from an auto-mix syringe for both Tempolok and Resiment Ready-Mix. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549118364 FDA UDI
FDA Product Code: EIY FDA UDI
GMDN Term: Dental material mixing nozzle 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

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

Yes

FDA UDI

Category: Dental material mixing nozzle

Tempolok Syringe Mixing tips 15 pcs by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
#1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
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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: Sterngold Dental LLC

Sources (1)

FDA UDI de0bf957-2c7e-4611-b63c-4f42fad459bb 34 fields · synced Jun 1, 2026