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 |
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| Device Name | PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR |
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| Applicant | Dentsply Intl. |
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| Product Code | KLE · Dental |
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| Decision Date | Jan 22, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 872.3200 |
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| Device Class | Class 2 |
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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)
Related Devices
- K982394 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM · Dentsply Intl. · Sep 21, 1998
- K962348 — PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT · Dentsply Intl. · Jul 18, 1996
- K051463 — XENO ADHESIVE WITH ACTIVATOR · Dentsply Intl. · Jul 12, 2005
- K070215 — TOKUYAMA BOND FORCE · Tokuyama Dental Corporation · Mar 30, 2007
- K151619 — Prime&Bond Elect Universal Dental Adhesive · Dentsply International, Inc. · Oct 30, 2015
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
(717) 845-7511
Fax (717) 854-2343
P. J. Lehn Telefax (717) 849-6343
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.
