(62 days)
RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.
The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
This document is a 510(k) summary for a dental adhesive (RM Bond Adhesive) and does not contain the detailed study information typically found in a clinical trial report or a performance study. The provided text indicates that the device is substantially equivalent to a predicate device but does not include acceptance criteria, performance data, or study methodologies that would allow for a comprehensive answer to your questions.
Therefore, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The content is focused on regulatory submission for substantial equivalence, not on a detailed scientific or clinical study report.
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Image /page/0/Picture/1 description: The image shows the logo for Pentron Clinical Technologies, LLC. The logo features the company name in a simple, sans-serif font, with "Pentron" on the top line and "Clinical" on the second line. Below that, in a smaller font, is "Technologies, LLC." To the left of the company name is a graphic of horizontal lines that are different lengths.
6.0 510(K) SUMMARY
DEC 0 4 2007
Pentron Clinical Technologies, LLC. 68 North Plains Industrial Road Wallingford, CT 06492 Tel: 203-265-7397 Fax: 203-284-4986 Contact: Greg Moreau
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Trade Name: Common Name: Classification Name:
RM Bond Adhesive Bracket Adhesive Adhesive, Bracket & Tooth Conditioner, Resin, 21CFR 872.3275, DYH
RM Bond Adhesive product performs the same intended function as its predicate device, APC Plus Adhesive (reference K020394), for orthodontic appliance applications. Both devices are intended for indirect bonding of appliance materials to teeth in order to facilitate orthodontic treatment.
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The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations.
Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
A review for safety and effectiveness was performed and found not to have been affected.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and a single vertical line to the right of the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2007
Mr. Greg Moreau Director, Quality Systems Pentron Clinical Technologies, LLC 68-70 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K072830
Trade/Device Name: RM Bond Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH, EBF Dated: September 28, 2007 Received: October 3, 2007
Dear Mr. Moreau:
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. Moreau
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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sayle Y. M, chane DMD
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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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): K072830
DEVICE NAME: RM Bond Adhesive
INDICATION FOR USE:
RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.
(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) |
Suan Purser
cl, Dental Davic
K072030
510(k) Submission for RM Bond Adhesive
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
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.(b)
Classification. Class II.