(36 days)
No
The device description and performance studies focus on the material properties and bonding capabilities of the adhesive, with no mention of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an adhesive for bonding orthodontic brackets, which is a supportive material for a therapeutic process (orthodontics) rather than a therapeutic agent itself.
No
The device description indicates it is an adhesive system used for bonding orthodontic brackets, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a "fluoride-releasing, light-cured, color changing adhesive" supplied in "push syringes or syringe tips," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding orthodontic brackets in the oral cavity of dental patients. This is a direct application within the body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description details a material used for bonding, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
EVOLVE is a fluoride-releasing, light-cured orthodontic bracket bonding to the wa EVOLVE is a finoride-teleasing, ingilt cared criticalently of EVOLVE is identical to the unmodified (predicate) device Light Bond with Fluoride.
Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.
Product codes
DYH
Device Description
EVOLVE is a fluoride-releasing, light-cured, color changing adhesiests who type of orthodontic bracket in bonding to any enamel, porcelain, composite or metal surfaces when properly conditioned. It is a highly filled, smooth, tacky paste that helps provent bracket fination and delivers maximum bond strength on curing. Its contrasting blue color facilitates the ease of placement in every in in mych denvers maximulli bond sirengin on cannig. To consuming one cored. The material is supplied in push syringes or syringe tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
EVOLVE was tested for biocompatibility and it was found to be non-toxic. It is concluded that he a light Pord information supplied in this submission has proven that EVOLVE is as safe and effective as Light Bond information supplied in this submission has proposed changes do not affect the safety and efficacy of the modified product, EVOLVE.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 1 6 2003
Page 7-1
23551
Section 7 SPECIAL 510 (k) SUMMARY
| 1. Applicant: | Reliance Orthodontic Products, Inc.
1540 W. Thorndale Ave
Itasca, IL 60143 | |
|-----------------|----------------------------------------------------------------------------------|--|
| Contact Person: | Benjamin Lichtenwalner
Ph. 847-534-6146
Fax 847-534-6111 | |
| Date Prepared: | November 7, 2003 | |
2. Trade Name: EVOLVE
Common/Usual Name: Dental Orthodontic Adhesive Common/Usual Name: Donal Ormodonial Hancer.
Classification/Name: Class II per 21 CFR 872.3750/Bracket adhesive resin and tooth conditioner
-
- Predicate (un-modified) Device: Light Bond with Fluoride, cleared under K895522 dated 12/7/1989
4. Description of Applicant Device:
Description of Applicant Device.
EVOLVE is a fluoride-releasing, light-cured, color changing adhesiests who type of orthodontic bracket in bonding to any enamel, porcelain, composite or metal surfaces when properly conditioned. It is a highly filled, smooth, tacky paste that helps provent bracket fination and delivers maximum bond strength on curing. Its contrasting blue color facilitates the ease of placement in every in in mych denvers maximulli bond sirengin on cannig. To consuming one cored. The material is supplied in push syringes or syringe tips.
5. Intended Use of Applicant Device:
Intended Use of Applicant Device.
EVOLVE is a fluoride-releasing, light-cured orthodontic bracket bonding to the wa EVOLVE is a finoride-teleasing, ingilt cared criticalently of EVOLVE is identical to the unmodified (predicate) device Light Bond with Fluoride.
6. Technological Characteristics:
Technological Characteristics.
EVOLVE posses the same technological characteristics as the un-modified charge a side by aide Bond with Fluoride and has similar physical properties. Below is a table which shows a side-by-side comparison of the technological characteristics.
| Technological Characteristics | Evolve | Light Bond with Fluoride |
|---|---|---|
| Intended use | Dental Bracket Adhesive | Dental Bracket Adhesive |
| Chemical Composition | Light cured, fluoride-releasing, | |
| glass filled, Dimethacrylate- | ||
| based composite | Light cured, fluoride-releasing, | |
| glass filled, Dimethacrylate- | ||
| based composite | ||
| Mechanical /physical properties | Highly viscous, smooth, tacky | |
| paste. High bond strength | Highly viscous, smooth, tacky | |
| paste. High bond strength |
EVOLVE was tested for biocompatibility and it was found to be non-toxic. It is concluded that he a light Pord information supplied in this submission has proven that EVOLVE is as safe and effective as Light Bond information supplied in this submission has proposed changes do not affect the safety and efficacy of the modified product, EVOLVE.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's full name and national affiliation. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2003
Reliance Orthodontic Products, Incorporation C/O Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporation 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K033551
Trade/Device Name: EVOLVE Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 03, 2003 Received: December 08, 2003
Dear Mr. Lichtenwalner:
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.
2
Page 2 – Mr. Lichtenwalner
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) 594-4618. 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,
Chus
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
3
Indications for Use
510(k) Number (if known): K033551
Device Name: EVOLVE
Indications For Use:
-
- Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.
Prescription Use ✓ AND/OR (Part 21 CFR 801 Subpart D)
- Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.
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)
Susa R
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: C633331
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