QuickLine Soft Reline Material 50ml cartridge, 12 mixing tips

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: QuickLine Soft Reline Material 50ml cartridge, 12 mixing tips FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: Long term soft relining material FDA UDI
Model / Reference: 220181 FDA UDI
Description: Long term soft relining material FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549118319 FDA UDI
510(k) Number: K992609 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silicone dental impression material

QuickLine Soft Reline Material 50ml cartridge, 12 mixing tips by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Silicone dental impression material.

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BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
Polysil Multipurpose Regular Set — Scican GmbH · Class II
PERFECTO — CROWN DELTA CORP. · Class II
Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I

Cleared under the same submission

K992609 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI 13ee0a7d-7309-4906-90d5-8ebb33e4bba5 35 fields · synced Jun 6, 2026