(69 days)
D3 Chroma is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.
D3 Chroma is a chromatic orthodontic bonding adhesive. D3 Chroma is designed specifically for use with Ormco Damon 3 and Spirit brackets, however bonding of all appliances including metal, ceramic and plastic are indicated. This single paste bonding adhesive has a blue color that enhances ease of use, specifically during bonding and post treatment adhesive remnant removal procedures. During treatment, the patient's body temperature is above the color transition temperature and the adhesive takes on the color of the enamel. D3 Chroma has very fast light cure properties and achieves high strength allowing active archwires to be placed immediately. D3 Chroma is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary for the D3 Chroma orthodontic adhesive, primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and claims substantial equivalence, but it does not include:
- A table of acceptance criteria and reported device performance: While it mentions properties like "fast light cure" and "high strength," no specific quantitative acceptance criteria or detailed performance data are presented.
- Sample size used for the test set and data provenance: No information about a test set or its sample size is provided.
- Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not discussed.
- Adjudication method: Not mentioned.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is described. This device is an adhesive, not an AI-assisted diagnostic tool.
- Standalone (algorithm only) performance: Not applicable as it's an adhesive, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable for this type of device.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory submission for a physical medical device (orthodontic adhesive) and not a study on an AI/ML-based diagnostic or prognostic device that would typically involve the kind of information you are asking for (e.g., ground truth, expert consensus, training/test sets, MRMC studies).
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Image /page/0/Picture/1 description: The image shows the Sybron Dental Specialties logo, along with the date November 15, 2004. The logo is a stylized "sds" with a swoosh above it. Below the logo, the text "SYBRON DENTAL SPECIALTIES" is printed. The text "Section III - 510(k) Summary of Safety and Effectiveness" is at the bottom of the image.
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: September 2004
Device Name:
- Trade Name -- D3 Chroma .
- . Common Name - Orthodontic Bonding Adhesive
- Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § 872.3750 .
Devices for Which Substantial Equivalence is Claimed:
- . Reliance Orthodontic Products, Inc., Light Bond
- . 3M Unitek Dental Products Division, Transbond XT
Device Description:
D3 Chroma is a chromatic orthodontic bonding adhesive. D3 Chroma is designed specifically for use with Ormco Damon 3 and Spirit brackets, however bonding of all appliances including metal, ceramic and plastic are indicated. This single paste bonding adhesive has a blue color that enhances ease of use, specifically during bonding and post treatment adhesive remnant removal procedures. During treatment, the patient's body temperature is above the color transition temperature and the adhesive takes on the color of the enamel. D3 Chroma has very fast light cure properties and achieves high strength allowing active archwires to be placed immediately. D3 Chroma is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques.
Intended Use of the Device:
The intended use of D3 Chroma is as a light-cured orthodontic bonding adhesive designed to be used for the attachment of orthodontic appliances to teeth.
Substantial Equivalence:
D3 Chroma is substantially equivalent to other legally marketed devices in the United States. D3 Chroma functions in a manner similar to and is intended for the same use as the products Light Bond and Transbond XT cleared for marketing for Reliance Orthodontic Products, Inc. and 3M Unitek Dental Products Division, respectively.
1717 West Collins Avenue, Orange, CA 92867 800-537-7824 714-516-7400
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three horizontal lines extending from its head, resembling feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2004
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K042422
Trade/Device Name: D3 Chroma Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: September 02, 2004 Received: September 07, 2004
Dear Ms. Boswell:
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 predically equivalent (for the indications for the indications for 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, god 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 carter Frient 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. Colleen Boswell
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/dsma/dsmamain.html
Sincerely yours.
Ola
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):
Device Name: D3 Chroma
Indications For Use:
D3 Chroma is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.
Prescription Use (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)
Susan Runne
(Division Sign-Off) (Division Orginesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number:________________________________________________________________________________________________________________________________________________________________
§ 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.