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Aqua Bond Sealant

FDA UDI

Class II (US FDA UDI)

by Xemax Surgical Products, Inc.

Identity

Trade Name
Aqua Bond Sealant FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Aqua Bond Sealant is intended to increase adhession to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel) and composite restorations without additional primers. FDA UDI
Model / Reference
CLABP FDA UDI
Description
Aqua Bond Sealant is intended to increase adhession to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel) and composite restorations without additional primers. FDA UDI

Identifiers

Catalog Number
CLABP FDA UDI
Primary DI / UDI-DI
D867CLABP0 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

No

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

Aqua Bond Sealant by Xemax Surgical 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
Xemax Surgical Products, Inc.

Sources (1)

  • FDA UDI 1689fafb-1398-423f-b548-d036fa0d9020 37 fields · synced May 30, 2026