(77 days)
KO23042
No
The summary describes a light cure primer for bonding orthodontic appliances and does not mention any AI or ML capabilities.
No
The device is a light cure primer used for bonding orthodontic appliances, which is generally considered a dental material rather than a therapeutic device. Therapeutic devices are typically those that prevent, treat, or diagnose a disease or condition.
No
The device is a light cure primer used for bonding orthodontic appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a "Bracket Adhesive Resin and Tooth Conditioner," 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 "bonding orthodontic appliances to etched enamel." This is a direct application to the patient's tooth structure for a therapeutic purpose (orthodontic treatment).
- Device Description: The description "Bracket Adhesive Resin and Tooth Conditioner" further reinforces its use in a clinical setting for bonding.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, Opal® Seal is a dental material used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Opal® Seal is a light cure primer that is used when bonding orthodontic appliances to etched enamel.
Product codes
DYH
Device Description
Opal® Seal is a light cure primer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PQ1 (KO23042)
Reference Device(s)
Solo Ortho (K990743), LED Pro Seal (K073243)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section 5
APR 2 9 2009
Traditional 510(k) Summary
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared: Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 February 11, 2009
Name of the Device
| Trade Name: | Opal® Seal |
|---|---|
| Common Name: | Bracket Adhesive Resin and Tooth Conditioner |
| Device Classification: | II |
| Classification Product Code: | DYH |
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate devices is: PQ1 (KO23042). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. The Indications for Use have been changed.
Opal® Seal is also very similar to two of our competitor's products namely: Solo Ortho (K990743) manufactured by Sybron Dental Specialties, Inc, 1717 West Collins Ave., Orange, CA 92867 and, LED Pro Seal (K073243) manufactured by Reliance Orthodontic Products, 1540 West Thorndale Ave. Itasca, IL, 60143.
.. .
1
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 stylized eagle with three overlapping wing segments, representing health, services, and people. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated' 505 West 10200 South South Jordan, Utah 84095
APR 2 9 2009
Re: K090355
Trade/Device Name: Opal® Seal Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: April 9, 2009 Received: April 10, 2009
Dear Ms. Rogers:
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 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.
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.
2
Page 2- Ms. Rogers
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Dunne
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K090355 Sheet 1
Statement of Indications for Use
510(k) Number (if known): _
Opal® Seal Device Name: __
Indications for Use:
Opal® Seal is a light cure primer that is used when bonding orthodontic appliances to etched enamel.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pare
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K962335
Page _1_of _1
(Posted November 13, 2003)