PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR

K964525 · Dentsply Intl. · KLE · Jan 22, 1997 · Dental

Device Facts

• Record ID: K964525
• Device Name: PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
• Applicant: Dentsply Intl.
• Product Code: KLE · Dental
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired. Also because of the self-cure capability, use of the Bonding Agent and Activator together allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE.

Device Story

One-component, no-mix visible light curable dental bonding agent containing fluoride; used with new Prime & Bond™ Self-Curing Activator (acetone/ethanol solution of aromatic sulfinic acid salt). Activator initiates self-cure free radical polymerization of monomers/oligomers in bonding agent. Used by dental practitioners in clinical settings. Enables dual-cured adhesive techniques and bonding of amalgam restorations to tooth structures. Benefits include expanded clinical utility for self-cure applications and improved restorative adhesion.

Clinical Evidence

Bench testing only; includes performance data for the bonding agent/activator combination and cytotoxicity test results for the activator's active ingredient.

Technological Characteristics

One-component, no-mix visible light curable resin bonding agent; contains fluoride. Activator is an acetone/ethanol solution of an aromatic sulfinic acid salt. Initiates free radical polymerization.

Indications for Use

Indicated for dental bonding of restorative materials to dentin and enamel, including dual-cured adhesive applications and adhesion of amalgam restorations to tooth structures.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Scotchbond M.P. Plus Dental Adhesive System (K942493)
• Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent (K962348)

Submission Summary (Full Text)

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JAN 22 1997 510(k) SUMMARY K964525 Page 1 of 2

DENTSPLY

NAME & ADDRESS: DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
[phone]
Fax [phone]
P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn DATE PREPARED: November 11, 1996

TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
WITH ACTIVATOR

COMMON OR USUAL NAME: Bonding agent

CLASSIFICATION NAME: Resin tooth bonding agent 21 CFR, 872.3200

PREDICATE DEVICES: Scotchbond M.P. Plus Dental Adhesive System K942493
Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent K962348

DESCRIPTION AND INTENDED USE: Prime & Bond™ 2.1 Multipurpose Dentin/Enamel
Bonding Agent is a one-component, no-mix visible light curable dental bonding
agent that contains fluoride. No changes have been made to Prime & Bond™ 2.1
Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical
composition or manufacturing process.

A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime &
Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner
to use self-cure bonding techniques for the current Indications for Use of the
Bonding Agent where a dual-cured adhesive may be desired.

Also because of the self-cure capability, use of the Bonding Agent and Activator
together allows adhesion of amalgam restorations to tooth structures, which is
a NEW INDICATION FOR USE.

Prime & Bond™ Self-Curing Activator is an acetone/ethanol solution of an
aromatic sulfinic acid salt. When applied in combination with Prime & Bond™ 2.1
Multipurpose Dentin/Enamel Bonding Agent, the Activator initiates a self-cure,
free radical polymerization of the monomers and oligomers present in the Prime
& Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent.

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510(k) SUMMARY (cont'd.)
Page 2 of 2

# TRADE NAME: PRIME & BOND™ 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT WITH ACTIVATOR

TECHNOLOGICAL CHARACTERISTICS: No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process.

All of the components of the Prime & Bond™ Self-Curing Activator have been used in legally marketed devices or have been proven to be safe for dental use.

We believe the fact that Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent has not been changed, the prior use of the Prime & Bond™ Self-Curing Activator components in predicate devices, the performance data presented for the use of Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent with the Prime & Bond™ Self-Curing Activator, and the cytotoxicity test results of the Activator active ingredient support the safety and effectiveness of Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent when used with Prime & Bond™ Self-Curing Activator for the new indications for use.