BOND 1 C & B

K994359 · Jeneric/Pentron, Inc. · KLE · Mar 21, 2000 · Dental

Device Facts

• Record ID: K994359
• Device Name: BOND 1 C & B
• Applicant: Jeneric/Pentron, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Device Story

Bond 1 C&B is a dental adhesive system used by dentists for bonding composite restorative materials to tooth structure (dentin/enamel) and various restorative substrates (metal, porcelain, glass). The device functions as a chemical bonding agent applied during restorative procedures. It utilizes an alcohol-based solvent system, which distinguishes it from the predicate device (Bond 1, K973388) that uses acetone. This formulation change is intended to reduce technique sensitivity, increase working time, and decrease the potential for post-operative sensitivity. The product is applied by the clinician in a dental office setting to facilitate the adhesion of fillings or luting of restorations, ultimately improving the retention and clinical success of dental restorations.

Clinical Evidence

No clinical performance investigations were conducted. The device relies on substantial equivalence to the predicate. Cytotoxicity studies are available upon request.

Technological Characteristics

Dental adhesive system; alcohol-based solvent formulation. Designed for bonding composites to dentin, enamel, metal alloys (amalgam, gold, semi-precious, non-precious), porcelain, and glass. No specific ASTM standards or complex software/electronic components described.

Indications for Use

Indicated for dental bonding procedures, specifically adhesion to dentin, bonding of polymeric filling materials (composites), and bonding of composites to metal (amalgam, gold, semi-precious, non-precious alloys), porcelain, and glass, including luting to dentin and enamel.

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

• Bond 1 (K973388)

Submission Summary (Full Text)

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MAR 2 1 2000

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# 21.0 510(K) SUMMARY

Jeneric/Pentron, Inc. Submitter: 53 North Plains Industrial Road Address: Wallingford, Connecticut 06492 Contact Tel: [phone] X619 Contact Fax: [phone] Contact Person: Annmarie Tenero Date Summary Prepared: March 14, 2000

Bond 1 C&B is substantially equivalent to Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used with other conditions for bonding of composite to metal including, amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Bond 1 C&B contains Alcohol and Bond 1 K973388 contains Acetone. Bond 1 C&B will reduce the technique sensitivity of bonding, increasing the working time and decreasing the potential for sensitivity. However, some dentists prefer to use either Acetone or Alcohol.

The safety and effectiveness is not affected due to Alcohol being used in Bond 1 C&B instead of Acetone, which Bond 1 contains. This will reduce the technique sensitivity bonding, increasing the working time and decreasing the potential for sensitivity.

No clinical performance investigations were conducted on Bond 1 C & B since it is substantially equivalent to Bond 1, K973388. Cytoxicity studies will be furnished upon request. Materials in Bond 1 C&B are known in the industry.

Jeneric/Pentron, Inc. 510(k) Summary - Bond 1 C&B March 14, 2000

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MAR 2 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

K994359 Re : Bond 1 C&B Trade Name: Requlatory Class: II Product Code: KLE Dated: March 3, 2000 Received: March 13, 2000

Dear Ms. Tenero:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listinq of devices, qood 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Tenero

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 leqally 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,

Patricia Cucentiffer

Timothy A. Ulatowski 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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### 5.0 INDICATION FOR USE STATEMENT

# 510(k) NUMBER (IF KNOWN): K994359

DEVICE NAME: BOND 1 C& B

INDICATION FOR USE:

Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|-----------------------------------------------|
| | OR |
| | Over-The-Counter-Use (Optional Format 1-2-96) |

| | <div>Susan Runne</div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K994359 |

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