EVERBOND

K983414 · Espe Dental AG · KLE · Dec 16, 1998 · Dental

Device Facts

• Record ID: K983414
• Device Name: EVERBOND
• Applicant: Espe Dental AG
• Product Code: KLE · Dental
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bonding of enamel/dentin and composite or compomer restorative materials.

Device Story

Everbond® is a resin-based tooth bonding system used by dental professionals to adhere composite or compomer restorative materials to tooth structure. The system consists of an etching gel (MiniTip® Etching Gel) and a primer/bonding agent. The clinician applies the etching gel to the tooth surface, followed by the primer/bonding agent, to facilitate the bonding of restorative materials. This process improves the retention of dental restorations, benefiting patients by ensuring the stability and longevity of composite or compomer fillings.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically comparative shear bond strength studies performed by independent institutes (University of Houston and University of Regensburg) and compositional analysis against predicate devices.

Technological Characteristics

Resin-based dental bonding system comprising an etching gel and a primer/bonding agent. The system utilizes chemical adhesion principles to bond restorative materials to dentin and enamel. No specific materials standards or software algorithms are described.

Indications for Use

Indicated for bonding composite or compomer restorative materials to tooth structure (enamel and dentin).

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

• MiniTip® Etching Gel (K810266)
• Bond & Prime 2.1® (K962348)
• Pertac® II (K962440)
• Hytac® (K962442)
• Hytac® OSB (K962442)

Submission Summary (Full Text)

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DEC 1 6 1998

K983414

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.

ESPE is submitting a 510(k) premarket notification for its resin-based tooth bonding system, tradenamed Everbond®. The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel), and is composed of an etching gel and a primer/bond formulation. The etching gel used in the Everbond® system is ESPE's 510(k) cleared MiniTip® Etching Gel (K810266). Concerning the intended use the priming/bonding agent is substantially equivalent to Dentsply's Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2.1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® II (K962440), Hytac® (K962442), and Hytac® OSB (K962442). All predicate devices are well-established and determined to be safe, effective and beneficial.

To support substantial equivalence to Dentsply's predicate product Bond & Prime 2.1® the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes (J. Powers, University of Houston, Texas, USA and K .- H. Friedl, University of Regensburg, Germany).

To support substantial equivalence to ESPE's predicate products Pertac® II, Hytac® and Hytac® OSB the compositions have been compared.

ESPE's 510(k) has been submitted on September, 14, 1998 by Dr. Andreas Petermann at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1368

Dr. A. Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld/Oberbay GERMANY

Re : K983414 Everbond® Trade Name: Requlatory Class: II Product Code: KLE September 14, 1998 Dated: September 28, 1998 Received:

Dear Dr. Petermann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Petermann

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE lll.

| Device Name: | Everbond® (System) |
|--------------|-----------------------------------------|
| | - Everbond® (priming and bonding agent) |
| | - MiniTip® Etching Gel |

Indications for use:

Bonding of enamel/dentin and composite or compomer restorative materials.

Susan Renner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription Use _ (Per 21 CFR 801.109)