(17 days)
The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.
The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer.
This document is a 510(k) summary for a medical device called "Opal Prime & Opal Bond/Orthodontic Composite Bracket System." It is a submission to the FDA for market clearance, not a study report detailing performance or acceptance criteria in the manner you've requested.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
This 510(k) summary primarily focuses on:
- Device Identification: Trade name, common name, classification, and regulation number.
- Predicate Device: Identifying a legally marketed device for comparison to claim substantial equivalence.
- Description and Intended Use: Explaining what the device is and what it's used for.
- Comparison with Predicate Device: Stating that the device is substantially equivalent to a predicate in composition and intended use.
- Regulatory Communication: Correspondence from the FDA granting substantial equivalence.
- Indications for Use: What the device is cleared for.
In the context of a 510(k) submission, "performance" is typically demonstrated through bench testing (e.g., bond strength, material properties) and comparison to the predicate device, rather than the kind of clinical study details you'd find for novel efficacy claims. The document asserts that the device is "substantially equivalent" to a predicate, meaning it performs as well as, or better than, the predicate device for its intended use, and is as safe and effective. However, the specific data for this comparison, including detailed acceptance criteria and the results of tests against those criteria, are not provided in this summary. They would be part of the full 510(k) submission, which is not this public summary document.
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Image /page/0/Picture/0 description: The image shows the logo for Ultra-Dent Products, Inc. The logo features a stylized "U" and "L" in bold, black font, followed by the words "ULTRA DENT" in a similar font. Below this, the words "PRODUCTS, INC." are written in a smaller, outlined font.
1071055
Section II
MAY - 3 2007
510(k) SUMMARY
Submitter:
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095 Phone: (801) 552-5512 Fax: (801) 553-4609 E-mail: wrobert@ultradent.com Robert Wang - Contact Person
Date Summary Prepared:
March 13, 2007
DEVICE
Trade Name:
Opal Prime & Opal Bond/ Orthodontic Composite Bracket System Common Name: Orthodontic Bracket Adhesive Primer & Paste
Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulation Number: 21 CFR 872.3750
PREDICATE DEVICE
Orthodontic Composite Bracket System Ultradent Products, Inc.
DESCRIPTION AND INTENDED USE:
The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.
COMPARISON WITH PREDICATE DEVICE
Opal Prime & Opal Bond is substantially equivalent in composition and intended use to the predicate device listed above. The modified Opal Prime & Opal Bond has the same Intended Use and has the same Fundamental Scientific Technology as the original Opal Prime & Opal Bond/ /Orthodontic Composite Bracket System currently manufactured by Ultradent Products Inc., please see Section VII for the entire comparison.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is written in a simple, sans-serif font. The logo is simple and recognizable, and it is often used to represent the Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Wang Senior Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
MAY - 3 2007
Re: K071055
Trade/Device Name: Opal Prime & Opal Bond Orthodontic Composite Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Codes: DYW and DYH Dated: March 13, 2007 Received: April 16, 2007
Dear Mr. Wang:
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. Robert Wang
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 your 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syvette y Michie, md.
Chiu S. Lin, PhD 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
510(k) Number (if known): Unknown K 07 1055
Device Name: Opal Prime & Opal Bond/Orthodontic Composite Bracket System
Indications for use:
The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.
Prescription Use: (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Runne
on of Anesthesiology, General Hospital, Jon Control, Dental Devices
2(k) Number: K871055
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.