Porcelain Conditioner

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Porcelain Conditioner FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: Reliance Porc-Etch™ & Porcelain Conditioner are intended for use in the preparation of glazed dental porcelain for bonding. . Porcelain Conditioner is a silane coupling agent which chemically unites with the silicon in the porcelain and the acrylic in chemical, light cure and dual cure adhesives. 8cc Porcelain Conditioner FDA UDI
Model / Reference: PO FDA UDI
Description: Reliance Porc-Etch™ & Porcelain Conditioner are intended for use in the preparation of glazed dental porcelain for bonding. . Porcelain Conditioner is a silane coupling agent which chemically unites with the silicon in the porcelain and the acrylic in chemical, light cure and dual cure adhesives. 8cc Porcelain Conditioner FDA UDI

Identifiers

Catalog Number: PO FDA UDI
Primary DI / UDI-DI: D798PO0 FDA UDI
510(k) Number: K880790 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 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

FDA UDI

Category: Dentine bonding agent/set

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

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Cleared under the same submission

K880790 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 5223318d-7a03-4342-a5d3-b29b62ff3e8e 37 fields · synced May 30, 2026