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FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: ASK FDA UDI
Generic Name: Dentine bonding agent/set FDA UDI
Device Name: The ASK, All surface bonding Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth. The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching, when required. The Assure Plus Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces. FDA UDI
Model / Reference: ASK FDA UDI
Description: The ASK, All surface bonding Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth. The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching, when required. The Assure Plus Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces. FDA UDI

Identifiers

Catalog Number: ASK FDA UDI
Primary DI / UDI-DI: D798ASK0 FDA UDI
FDA Product Code: KLE FDA UDI
DYH FDA UDI
KOJ FDA UDI
GMDN Term: Dentine bonding agent/set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3750 FDA UDI
872.6080 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: Dentine bonding agent/set Dental abrasive air jet system

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

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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 II	Pending data

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Manufacturer

Manufacturer: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI ff59eb17-ea33-49e4-888e-7d7014720ea3 36 fields · synced Jun 6, 2026