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Alpha-Bond® Activator

FDA UDI

Class II (US FDA UDI)

by Dental Technologies, Inc.

Identity

Trade Name
Alpha-Bond® Activator FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Alpha-Bond® Activator is the dual cure activator used in combination with Alpha-Bond® a 5th generation single component acetone based formulated to bond to multiple substrates for both direct and indirect bonding procedures. It contains a hydrophilic monomer that allows penetration into the tubules, intertubules and peritubuler dentin. For a single step light cure adhesive, use the bottle marked adhesive. By combining the dual cure activator with the adhesive, you can confidently bond to self cure composites and areas inaccessible to light. Kit Contains: 1 x 3ml Bottle FDA UDI
Model / Reference
211.0201.002 FDA UDI
Description
Alpha-Bond® Activator is the dual cure activator used in combination with Alpha-Bond® a 5th generation single component acetone based formulated to bond to multiple substrates for both direct and indirect bonding procedures. It contains a hydrophilic monomer that allows penetration into the tubules, intertubules and peritubuler dentin. For a single step light cure adhesive, use the bottle marked adhesive. By combining the dual cure activator with the adhesive, you can confidently bond to self cure composites and areas inaccessible to light. Kit Contains: 1 x 3ml Bottle FDA UDI

Identifiers

Catalog Number
211.0201.002 FDA UDI
Primary DI / UDI-DI
D73521102010020 FDA UDI
510(k) Number
K984503 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
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

Category: Dentine bonding agent/set

Alpha-Bond® Activator by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Cleared under the same submission

K984503 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Technologies, Inc.

Sources (1)

  • FDA UDI 6263655b-3171-42d9-801d-85e238a52b5f 37 fields · synced Jun 9, 2026