BOND-1 C & B

K013543 · Jeneric/Pentron, Inc. · KLE · Feb 22, 2002 · Dental

Device Facts

• Record ID: K013543
• Device Name: BOND-1 C & B
• Applicant: Jeneric/Pentron, Inc.
• Product Code: KLE · Dental
• Decision Date: Feb 22, 2002
• 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 various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359. We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Device Story

Bond-1 C&B is a dental resin bonding agent; subject submission adds Bond-1 Self Cure Activator component. Activator mixed with Bond-1 C&B enables dual-cure functionality (light-cure or self-cure). Used by dentists in clinical settings for restorative procedures; facilitates adhesion of composites to tooth structure or restorative materials. Output is a cured resin bond; assists in structural integrity of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental resin bonding agent; chemical composition modified by addition of self-cure activator to enable dual-cure (light/chemical) polymerization. Class II device (Product Code: KLE).

Indications for Use

Indicated for dental professionals requiring adhesion of polymeric filling materials (composites) to dentin, or bonding/luting of composite to metal (semi-precious/non-precious alloys), porcelain, and glass 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 C&B (K994359)

Submission Summary (Full Text)

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#### 510(K) SUMMARY 21.0

# FEB 2 2 2002

KO13543

Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited). I noo, 2011-01-2015 and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with To are adding a componia for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Jeneric/Pentron, Inc. 510K Submission - Bond 1 C&B K013543

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 2 2002

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

Re: K013543

Trade/Device Name: Bond-1 C & D Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 3, 2001 Received: December 4, 2001

Dear Ms. Tenero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Tenero

You must comply with all the Act's requirements, including, but not limited to: registration 1 od inust compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF Reviews the quality systems (QS) regulation (21 CFR Part 820); and if requirements to be relia product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 11ms letter will and wife of you to begine in 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]dditionally, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 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): K013543

#### Bond 1 C&B DEVICE NAME:

## INDICATION FOR USE:

Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Susan Runoy

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

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)

5.0

Jeneric/Pentron, Inc. 510K Submission - Bond 1 C&B K013543