(81 days)
Not Found
No
The device description and performance studies focus on material properties and clinical performance, with no mention of AI or ML.
No.
The device is a sealant used to protect enamel surfaces, not treat a disease or medical condition.
No
This device is described as a sealant for enamel surfaces and its performance studies focus on physical properties and toxicity, not on detection, diagnosis, or monitoring of any medical condition.
No
The device description clearly states it is a "fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "seal enamel surfaces around orthodontic brackets." This is a direct treatment or preventative measure applied to the patient's body.
- Device Description: The description details a material applied to the tooth surface and light-cured. This is a physical application, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVDs are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve any such examination of a specimen.
The device is a dental sealant, which is a therapeutic or preventative device applied directly to the patient.
N/A
Intended Use / Indications for Use
LED PRO SEAL® is intended to seal enamel surfaces around orthodontic brackets.
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
LED PRO SEAL® is a fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser. Upon delivery of one drop of LED PRO SEAL to a mixing pad, a thin coat of LED PRO SEAL is applied to a prepared enamel surface using a brush applicator and light cured for a minimum of 20 seconds with any halogen, plasma arc or cordless light capable of a 440-490 NM wavelength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel surfaces around orthodontic brackets
Indicated Patient Age Range
pediatric to adult
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)
Shear bond strength, Compressive strength, flexural strength, cumulative fluoride release and depth of cure testing comparisons conducted between LED PRO SEAL® and the predicate device, original PRO SEAL® demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness.
Additionally, toxicity testing was conducted by a Cytotoxicity Study using the ISO 10993-5 Agarose Overlay Method (Solid). LED PRO SEAL was found to cause mild cell lysis or toxicity (generating grade 2 for mild reactivity). LED PRO SEAL met the requirements of ISO10993-5 for a grade 2 material showing evidence that the product is safe to use. Sufficient labeling is provided for proper use and indications.
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.
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.
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
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
Reliance Orthodontic Products, Inc.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 · Itasca, IL · 60143 · U.S.A.
FEB - 8
Section 5.0 510 (k) Summary
Note: This summary is provided in accordance with the requirements of 21CFR807.92 (c).
| 510 (k) Owners Name: | Reliance Orthodontic Products, Inc.
Paul Gange, President | |
|----------------------|--------------------------------------------------------------|--|
| Address: | 1540 West Thorndale Avenue
Itasca, Il 60143 USA | |
| Phone Number: | 630-773-4009 | |
| Fax Number: | 630-250-7704 | |
| Contact Person: | Paula Wendland, Regulatory Affairs Manager
(Preparer) | |
Date 510 (k) Summary was Updated: January 30, 2008
Medical Device Name:
- Trade name LED PRO SEAL® .
- Common name Tooth Surface Sealant .
- Classification name Coating Material for Resin Fillings t (21CFR872.3310, Product Code EBD, Class II Device)
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:
- · PRO SEAL® (510(k) submission K021503 under the Bisco. Inc. Uninhibited product)
1
Reliance Orthodontic Products, Inc.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 - Itasca, IL - 60143 · U.S.A
DESCRIPTION OF THE APPLICANTS DEVICE:
LED PRO SEAL® is a fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser. Upon delivery of one drop of LED PRO SEAL to a mixing pad, a thin coat of LED PRO SEAL is applied to a prepared enamel surface using a brush applicator and light cured for a minimum of 20 seconds with any halogen, plasma arc or cordless light capable of a 440-490 NM wavelength.
INTENDED USE AND POPULATION:
LED PRO SEAL is intended to seal enamel surfaces around orthodontic brackets. The intended patient population ranges from pediatric to adult recipients of orthodontic or dental treatment.
TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:
Performance Characteristics of Reliance LED PRO SEAL versus original Reliance PRO SEAL®:
| Property | LED PRO SEAL® | Original PRO SEAL® |
|---|---|---|
| Intended Use | Light Cure Filled Surface Sealant of enamel | Light Cure Filled Surface Sealant of enamel |
| Mechanical / | ||
| Physical | ||
| Properties | • Light Cure surface sealant with | |
| any halogen, plasma arc or 440- | ||
| 490 nm cordless LED curing | ||
| light | ||
| • Fluoresces when exposed to a | ||
| blacklight. | • Light Cure surface sealant with | |
| any halogen or 380-420 nm | ||
| cordless LED curing light. | ||
| • Fluoresces when exposed to a | ||
| blacklight. | ||
| Chemical | ||
| Composition | Acrylate-based Resin with | |
| photoinitiator, fluorescing and | ||
| fluoride releasing agent | Acrylate-based Resin with | |
| photoinitiator , fluorescing and | ||
| fluoride releasing agent |
Shear bond strength, Compressive strength, flexural strength, cumulative fluoride release and depth of cure testing comparisons conducted between
2
Image /page/2/Picture/6 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a stylized "R" inside a circle, which is a registered trademark symbol. Below the symbol is the company name, "Reliance Orthodontic Products, Inc." in a cursive font.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 · Itasca, IL · 60143 · U.S.A.
LED PRO SEAL® and the predicate device, original PRO SEAL® demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness.
Additionally, toxicity testing was conducted by a Cytotoxicity Study using the ISO 10993-5 Agarose Overlay Method (Solid). LED PRO SEAL was found to cause mild cell lysis or toxicity (generating grade 2 for mild reactivity). LED PRO SEAL met the requirements of ISO10993-5 for a grade 2 material showing evidence that the product is safe to use. Sufficient labeling is provided for proper use and indications.
Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Inc. 800-323-4348 / 630-773-4009 Fax: 630-250-7704
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 2008
Mr. Paul Gange President Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca, Illinois 60143
Re: K073243
Trade/Device Name: LED PRO SEAL® Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: February 1, 2008 Received: February 1, 2008
Dear Mr. Gange:
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.
4
Page 2 - Mr. Gange
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/industry/support/index.html.
Sincerely yours,
Clars
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
5
Reliance Orthodontic Products, Inc.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 PO Box 678 - Itasca, IL - 60143 - U.S.A.
SECTION 6.0
INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K073243
Device Name:
Indications for Use:
LED PRO SEAL® is intended to seal enamel surfaces around orthodontic brackets.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Susan Nunn
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073242