(127 days)
The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.
The device is a ceramic orthodontic bracket which will encompass maxillary and mandibular brackets from 2nd bicuspid to 2m bicuspid. The Damon 4Clear appliance has both aesthetic and self-ligating qualities. The Damon 4Clear is designed with 1) improved open and close functionality and increased corner radius for increased patient comfort, 2) enhanced bracket placement with placement jigs and 3) improved overall bracket performance without changing treatment mechanics, with rotation and torque control similar to other Damon metal brackets. This system is a bondable device for fixed attached orthodontics.
I'm sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (Damon 4Clear orthodontic bracket) seeking clearance from the FDA for substantial equivalence to existing legally marketed devices.
The content focuses on:
- Device Description: What the device is.
- Intended Use: What the device is for.
- Substantial Equivalence Claim: How it is similar to other devices already on the market.
- FDA Clearance Letter: Official communication from the FDA confirming clearance based on substantial equivalence.
- Indications for Use: The specific medical purposes for which the device is intended.
A 510(k) submission generally does not require extensive clinical trials or performance studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would. Instead, substantial equivalence is often demonstrated through comparisons to predicate devices in terms of materials, design, intended use, and performance characteristics. While some performance testing might be conducted to support the substantial equivalence claim, the provided text does not detail any specific acceptance criteria or study results that directly address the points in your request.
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SYBRON DENTAL SPECIALTIES
FP 2 4 2008
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: May 2008
Device Name:
- Trade Name Damon 4Clear .
- Common Name Bracket, Ceramic, Orthodontic .
- Classification Name Bracket, Plastic, Orthodontic, per 21 CFR § 872.5470 ◆
Devices for Which Substantial Equivalence is Claimed:
- Ormeo Corporation, Lumina .
- Dentsply International, In-Ovation C .
- 3M Unitek Corporation, Clarity Modified Ceramic Bracket .
Device Description:
The device is a ccramic orthodontic bracket which will encompass maxillary and mandibular brackets from 2nd bicuspid to 2m bicuspid. The Damon 4Clear appliance has both aesthetic and self-ligating qualities. The Damon 4Clear is designed with 1) improved open and close functionality and increased corner radius for increased patient comfort, 2) enhanced bracket placement with placement jigs and 3) improved overall bracket performance without changing treatment mechanics, with rotation and torque control similar to other Damon metal brackets. This system is a bondable device for fixed attached orthodontics.
Intended Use of the Device:
The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.
Substantial Equivalence:
Damon 4Clear is substantially equivalent to other legally marketed devices in the United States. Dumon 4Clear functions in a manner similar to and is intended for the same use as the In-Ovation C bracket marketed by Dentsply International, the Clarity Modified Ceramic Bracket marketed by 3M Unitck Corporation and the Lumina bracket formerly marketed by Ormco Corporation.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that converge at the head and tail. The overall design is simple and iconic, representing the department's role in protecting the health of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2008
Ormco Corporation C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialist, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K081415
Trade/Device Name: Damon 4Clear Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: N.IM Dated: August 14, 2008 Received: September 10, 2008
Dear Ms. Garman:
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 - Ms. Garman
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Thhmuele Lender frell
Chiu S. Lin, Ph. D Division 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
K681415 510(k) Number (if known):
Device Name: Damon 4Clear
Indications For Use:
The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.
Prescription Use レ (Part 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)
1
Susan Fusse
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081415
§ 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.