IDEAL 1 ORTHODONTIC BAND CEMENT

K040375 · Dentsply Intl. · DYH · Apr 2, 2004 · Dental

Device Facts

• Record ID: K040375
• Device Name: IDEAL 1 ORTHODONTIC BAND CEMENT
• Applicant: Dentsply Intl.
• Product Code: DYH · Dental
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

Bonding of orthodontic bands to natural and artificial tooth surfaces

Device Story

IDEAL® 1 Orthodontic Band Cement is a light-cure, two-part system consisting of an orthodontic cement and a primer; an optional tooth conditioner is available for high-stress bonding. The cement is supplied in syringes requiring no mixing; the primer is provided in unit-dose, self-dispensing capsules. Used by dental professionals in a clinical setting to secure orthodontic bands to tooth surfaces. The device facilitates the attachment of orthodontic hardware, aiding in orthodontic treatment.

Clinical Evidence

No clinical data; substantial equivalence supported by performance data and similarity to predicate device.

Technological Characteristics

Light-cure, two-part resin system; includes cement (syringe-dispensed) and primer (unit-dose capsule). Components consist of materials previously used in legally marketed dental devices.

Indications for Use

Indicated for bonding orthodontic bands to natural and artificial tooth surfaces.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• Ideal® 1 Orthodontic Bracket Adhesive (K033703)

Submission Summary (Full Text)

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K040375

APR - 2 2004

# 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York. PA 17405-087 ww dentsniv.com

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

February 11, 2004 DATE PREPARED:

TRADE OR PROPRIETARY NAME: IDEAL® 1 ORTHODONTIC BAND CEMENT

Bracket adhesive and tooth conditioner resin (872.3750) CL ASSIFICATION NAME:

Ideal® 1 Orthodontic Bracket Adhesive K033703 PREDICATE DEVICES:

The IDEAL® 1 ORTHODONTIC BAND CEMENT is a light-cure DI VICE DESCRIPTION: two-part system: an orthodontic cement and a primer. A tooth conditioner is available if desired for the highest stress bonding cases.

The cement is packaged in syringes. No mixing is necessary. The primer is packaged in unit do se, self-dispensing capsules.

The IDEAL® 1 ORTHODONTIC BAND CEMENT is indicated for INTENDED USE: bo iding of orthodontic bands to natural and artificial tooth surfaces.

TE CHNOLOGICAL CHARACTERISTICS: All of the components found in the IDEAL® l OI:THODONTIC BAND CEMENT have been used in legally marketed devices.

We believe that the prior use of the components of the IDEAL® 1 ORTHODONTIC BAND CEMENT in legally marketed devices, the performance data provided, and the similarity of the prodicate to the new device support the safety and effectiveness of the IDEAL® 1 OILTHODONTIC BAND CEMENT for the intended uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

APR = 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K040375

Trade/Device Name: IDEAL®1 Orthodontic Band Cement Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: February 11, 2004 Received: February 17, 2004

Dear Mr. Lehn:

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.

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Page 2 - Mr. Lehn

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-56. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours.

Chris Liu, Ph.D.

Chiu Lin, Ph.D. 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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## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

5040375 51((K) Number (if known):

### IDEAL® 1 ORTHODONTIC BAND CEMENT De vice Name:

Indications for Use:

Bonding of orthodontic bands to natural and artificial tooth surfaces

Prescription Use X (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)

Susan Russo

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

510(k) Number: J