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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 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 Unidose (single use) Assure Universal Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces. FDA UDI
Model / Reference
ASKU FDA UDI
Description
The ASK 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 Unidose (single use) Assure Universal 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
ASKU FDA UDI
Primary DI / UDI-DI
D798ASKU0 FDA UDI
FDA Product Code
KLE FDA UDI
KOJ FDA UDI
DYH FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 FDA UDI
872.6080 FDA UDI
872.3750 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reliance Orthodontic Products, Inc.

Sources (1)

  • FDA UDI 37f6b330-269a-4e5b-b06b-04d0182dcb9d 37 fields · synced Jun 8, 2026