GlassLok

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: GlassLok FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. This is the Blue GlassLok Economy Kit Kit contains: 100g GlassLok Powder, 75g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop FDA UDI
Model / Reference: GLEB FDA UDI
Description: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. This is the Blue GlassLok Economy Kit Kit contains: 100g GlassLok Powder, 75g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop FDA UDI

Identifiers

Catalog Number: GLEB FDA UDI
Primary DI / UDI-DI: D798GLEB0 FDA UDI
510(k) Number: K193388 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Glass ionomer dental cement

GlassLok by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glass ionomer dental cement.

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SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
GC Fuji II LC® — Gc America Inc. · Class II
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Cleared under the same submission

K193388 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: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI 76d46942-8ff7-4a9b-a007-3cd5ec312a5d 37 fields · synced May 30, 2026