(42 days)
Not Found
No
The summary describes a traditional orthodontic adhesive with no mention of AI or ML capabilities.
No.
The device is an adhesive for attaching orthodontic appliances to teeth, which is a supportive material for a therapeutic process (orthodontic treatment) but not a therapeutic device itself as it doesn't directly treat or prevent a disease or condition.
No
Explanation: The document describes the device as an orthodontic bonding adhesive used for attaching appliances to teeth, focusing on its physical properties and intended use as a sealant and paste. It does not mention any function for identifying, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a single component sealant and paste, which are physical materials, 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 the "attachment of orthodontic appliances to teeth." This is a direct application to the patient's body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description focuses on the physical properties and handling characteristics of the adhesive for bonding orthodontic appliances.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The device is an orthodontic adhesive, which is a medical device used for bonding purposes in the mouth.
N/A
Intended Use / Indications for Use
Ormco Enlight is a single component sealant and single component paste, visible light cured orthodontic bonding adhesive indicated for the attachment of orthodontic appliances to teeth.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
Ormco's Enlight is designed to fulfill all of the requirements of a successful orthodontic adhesive. These requirements are itemized below:
- Ease of placement: optimized resin blend that exhibits supert handling characteristics.
- Convenience: Both syringe and Unidse delivery systems are available.
- Enlight provides flouride release for caries protection during the orthodontic treatment period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
Effectiveness or suitability to the intended purpose of Enlight has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Orthodontic Adhesive performs as well or better than the predicate devices currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
SFP | 6 1997
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The characters appear to be 'K97289d'. The writing style is somewhat cursive, with some characters connected to each other.
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
Ormco Enlight Orthodontic Adhesive
Submitter
Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person
Device Name
Trade Name: Enlight ( Tentative Name ) Common Name: Visible Light Cured Orthodontic Bracket Adhesive and Sealant Classification Name; DYH DE(76) Adhesive, Bracket and Tooth Conditioner, Resin Class II
Devices for which Substantial Equivalence is Claimed
Unitek Transbond ( 3M ) and Light - Bond ( Reliance Orthodontic Products, Inc. )
BACKGROUND
Methacrylate ester monomer based adhesives have been used successfully for over thirty years to bond appliances to teeth during orthodontic treatment procedures. Early examples of these products were chemically cured ( autocure ) materials that required the mixing of a catalyst and base resin by the orthodontist immediately prior to positioning the bracket on the tooth. Because the working time of these materials was so unpredictable due to the effects of temperature and aging, many times the orthodontist would have to reposition the appliance and repeat the bonding process.
In 1992, Ormco Corportation introduced a product, "Sequence" (FDA Reference No. K914627) that employed a visible light curing initiation system for curing. Sequence was not time dependent and allowed the orthodontist to correctly position the bracket before curing with a 10 -20 second exposure to intense visible light. It is the next generation of visible light curing orthodontic adhesives that is the subject of this 510 ( k ) submission.
Enlight Orthodontic Adhesive and Sealant
Ormco's Enlight is designed to fulfill all of the requirements of a successful orthodontic adhesive. These requirements are itemized below:
-
Ease of placement: optimized resin blend that exhibits supert handling characteristics.
-
Convenience: Both syringe and Unidse delivery systems are available.
1
Page 2 of 2
-
- Enlight provides flouride release for caries protection during the orthodontic treatment period.
SAFETY
The safety of Ormco Enlight adhesive has been demonstrated by subjecting cured samples of the material to three biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. This testing was conducted by an independent laboratory which specializes in safety and toxicity evaluation.
-
- Test Type: Cytotoxicity Study ( Agarose Overlay )
-
- Test Type: Mucosal irritation in the rabbit vagina.
-
- Test Type: Dermal Contact sensitization ( Guinea Pig )
EFFICACY
Effectiveness or suitability to the intended purpose of Enlight has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Orthodontic Adhesive performs as well or better than the predicate devices currently on the market
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. William R. Pike Requlatory Affairs Specialist Sybron Dental Specialities, Incorporated 1717 W. Collins Avenue Orange, California 92667
Re: K972890 Enlight (Tentative Name) Trade Name: Requlatory Class: II Product Code: DYH Dated: July 30, 1997 Received: August 5, 1997
Dear Mr. Pike:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate abe beach in the 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Pike
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucurullo Hor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number: K972890
Device Name : Enlight Orthodontic Bracket Adhesive
Indications For Use : Ormco Enlight is a single component sealant and single component paste, visible light cured orthodontic bonding adhesive indicated for the attachment of orthodontic appliances to teeth.
| (Divi | |
|---|---|
| Di | Control, |
| a | Devices |
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972890 |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |