(90 days)
EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.
The device is a chromatic orthodontic bonding adhesive. This single paste bonding adhesive initially has a blue color that enhances ease of use. Upon curing, the final color takes on the shade of the tooth, rendering it unnoticeable. Envision has an extended working time and has a very fast light cure property that achieves high strength, allowing active archwires to be placed immediately. EnVision is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques
The provided text is a 510(k) summary and FDA clearance letter for the EnVision orthodontic bonding adhesive. It focuses on regulatory approval based on substantial equivalence to existing devices, product description, and intended use.
Crucially, this document does not contain any information regarding acceptance criteria, performance data, or a clinical study that would describe how the device meets such criteria. It's a regulatory document, not a scientific study report.
Therefore, I cannot provide the requested information from this text. The questions below would be answered with "information not found in the provided document."
Here is a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., bond strength, cure time, discoloration limits) nor does it report the device's performance against such criteria. The clearance is based on substantial equivalence to predicate devices, implying similar performance is expected, but no specific data is presented.
- Sample sized used for the test set and the data provenance: No test set is described, as no performance study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process for a test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an orthodontic bonding adhesive, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a physical product (adhesive), not an algorithm. Standalone algorithm performance is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described as no performance study is detailed.
- The sample size for the training set: No training set is applicable as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
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SEP 2 9 2003
Image /page/0/Picture/2 description: The image shows the logo for "sds Ormco SYBRON DENTAL SPECIALTIES". The logo has a curved line above the text. The text is in a bold, sans-serif font. The words "sds Ormco" are in a larger font than the words "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) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
June 2003 Date Summary Prepared:
Device Name:
- Trade Name -- EnVision .
- 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:
- 3M Unitek Dental Products Division, Transbond XT .
- Reliance Orthodontic Products, Inc., Light-Bond .
Device Description:
The device is a chromatic orthodontic bonding adhesive. This single paste bonding adhesive initially has a blue color that enhances ease of use. Upon curing, the final color takes on the shade of the tooth, rendering it unnoticeable. Envision has an extended working time and has a very fast light cure property that achieves high strength, allowing active archwires to be placed immediately. EnVision is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques
Intended Use of the Device:
The intended use of EnVision is as a light-cured orthodontic bonding adhesive that is designed to be used for the attachment of orthodontic appliances to teeth.
Substantial Equivalence:
EnVision is substantially equivalent to other legally marketed devices in the United States. EnVision functions in a manner similar to and is intended for the same use as the products Transhond XT and Light-Bond cleared for marketing for 3M Unitek Dental Products Division and Reliance Orthodontic Products, Inc., respectively.
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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 features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
SEP 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K032042
Trade/Device Name: Envision Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: June 23, 2003 Received: July 1, 2003
Dear Mr. 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 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. 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 (301) 594-4613. 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,
Susan O'Runner
Susan Runner, DDS, MA Interim 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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Se :tion I
Indications for Use Statement
Verl 3 - 4/24/96
Ar plicant: Ormco Corporation
51.)(k) Number (if known): K 032042
Device Name: EnVision
Incications For Use:
EnVision is a light-cured orthodontic bonding adhesive that is designed to be used for the att ichment of orthodontic appliances to teeth.
M. Udell for MSR
Division Sian Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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.