PRIMER PLUS

K091705 · Bisco, Inc. · KLE · Aug 28, 2009 · Dental

Device Facts

• Record ID: K091705
• Device Name: PRIMER PLUS
• Applicant: Bisco, Inc.
• Product Code: KLE · Dental
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Primer Plus is a universal restoration primer. The principle uses of the Primer Plus are: 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics). 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin).

Device Story

Primer Plus is a universal restoration primer used in dental procedures. It is applied by dental professionals to facilitate bonding during the placement of indirect restorations (e.g., crowns, endodontic posts) and for the intraoral repair of fractured dental prosthetics. The device utilizes standard monomer chemistry to improve adhesion between restorative materials—including metals, alloys, porcelain, zirconia, alumina, and composite resins—and the tooth structure. It is intended for clinical use in a dental office setting. By enhancing the bond strength between the restoration and the tooth, the primer helps ensure the longevity and stability of the dental repair or restoration, benefiting the patient by reducing the likelihood of restoration failure.

Clinical Evidence

Bench testing only. Biocompatibility evaluation conducted per FDA and international guidelines confirmed safety for the intended use.

Technological Characteristics

Universal restoration primer based on industry-standard monomer chemistry. Class II dental resin tooth bonding agent (21 CFR 872.3200).

Indications for Use

Indicated for use as a universal restoration primer for indirect restorations (composite, endodontic posts, metal/alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics) and intraoral repair of fractured crowns and bridges (metals/alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, composite resin).

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

• Clearfil Ceramic Primer (K061906)
• One Step Plus (K011159)

Submission Summary (Full Text)

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K091705

Image /page/0/Picture/1 description: The image shows the logo for BISCO. The logo consists of the letters "BISCO" in a stylized font, with each letter contained within a hexagon. Below the logo is the text "Bringing Science to the Art of Dentistry".

AUG 2 8 2009

## 510 (k) SUMMARY

Applicant: .

Contact Person:

Date Prepared: Trade Name: Common Name: Product Code: Classification/Name:

Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Michelle Schiltz-Taing Tel: [phone] Fax: [phone] June 9, 2009 Primer Plus Universal Restoration Primer KLE Resin tooth bonding Agent Class II per 21 CFR 872.3200

## Description of Applicant Device:

The Primer Plus is a universal restoration primer.

The principle uses of the Primer Plus are:

- 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics).
- 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin).

## Substantial Equivalence

All components of the Primer Plus are found in legally marketed predicate devices. The Primer Plus is based upon industry standard monomer chemistry and has similar technological characteristics as other legally marketed devices. Information is provided in this 510(k) submission that . the Primer Plus is substantially equivalent to the predicate devices Clearfil Ceramic Primer (K061906) and One Step Plus (K011159) in terms of intended use, indications for use, chemical composition and physical properties.

An evaluation of biocompatibility was conducted to determine the safety of the Primer Plus using FDA and internationally recognized guidelines. The conclusion of the safety evaluation and subsequent testing is that the Primer Plus is safe for its intended use.

Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to other legally marketed devices. It is concluded that the information supplied in this submission has proven the safety and efficacy of this product.

An ISO 13485 Certified Company

BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: [phone] www.bisco.com

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

JG 2 8 2009

Re: K091705

Trade/Device Name: Primer Plus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 9, 2009 Received: June 10, 2009

Dear Ms. Taing:

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 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.

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Page 2 - Ms. Taing

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Susan Suarez

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):

Device Name: Primer Plus

Indications for Use:

Primer Plus is a universal restoration primer.

The principle uses of the Primer Plus are:

- 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
K091705

- 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, 1 porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Miller for NSE

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091705