(215 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the varnish, with no mention of AI or ML.
Yes
The device is described as a "fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity," which indicates a therapeutic purpose.
No
Explanation: The device is a fluoride varnish used for cavity treatment and dentin hypersensitivity, not for diagnosing a condition or disease. It treats existing conditions rather than identifying them.
No
The device description clearly states it is a "rosin based 5% sodium fluoride varnish" and is available in "tray form unit doses." This indicates a physical substance and packaging, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to teeth as a cavity varnish and for treating dentin hypersensitivity. This is a direct treatment applied to the patient's body.
- Device Description: The description details a topical varnish that reacts with components in saliva and tooth structure to block tubules. This is a physical and chemical interaction happening in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information about a person's health. This device is applied directly to the tooth surface for therapeutic purposes.
N/A
Intended Use / Indications for Use
StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.
Product codes
LBH
Device Description
StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL.
Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.
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
Non-clinical performance testing on StarBright™ including fluoride release and tubule occlusion support substantial equivalence to the listed predicates. Biological testing included cytotoxicity, sensitization, and irritation. The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
Clinical performance data was not included.
Key Metrics
Not Found
Predicate Device(s)
K961893, K092141, K103160, K132109
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2014
Nanova Biomaterials, Incorporated Mr. Andrew Ritts Senior Scientist 3806 Mojave Court Columbia, MO 65202
Re: K140349
Trade/Device Name: StarBright™ 5% Sodium Fluoride Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 1, 2014 Received: August 8, 2014
Dear Mr. Ritts:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mr. Ritts
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Confidential
Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349
Section 4. Indications for Use Statement (As Required by 21 CFR 807.87(e))
510(k) Number (if known): K140349
Device Name: StarBright™ 5% Sodium Fluoride Varnish
Indications For Use:
StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image shows the word "NANOVA" in blue font. The font is sans-serif and the letters are bold. The background is white. The logo is simple and modern.
Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349
Section 5. 510(k) Summary
| 1) | Submitted By: | Nanova Biomaterials, Inc
3806 Mojave Ct.
Columbia, MO 65202
USA
(573)-875-6682 |
|----|------------------------------------|--------------------------------------------------------------------------------------------|
| | Contact Person: Andrew Ritts | Phone: (573) 823-3114 |
| | Secondary Contact: Kathryn Giddens | Phone: (573) 864-1701 |
| 2) | Establishment Registration No.: | NA |
| 3) | Date Prepared: | July 1st, 2014 |
| 4) | Device Trade Name: | StarBright™ 5% Sodium Fluoride Varnish |
| 5) | Device Common Name: | Dental Varnish |
| 6) | Device Classification Name: | Cavity Varnish |
| 7) | Classification Panel: | Class II |
| 8) | Device Class: | Dental |
9) Predicated Devices: StarBright™ 5% Sodium Fluoride Varnish is believed to be substantially equivalent to the following marketed products:
| 510(k)
Number | Name of Device | Product
Code | Company |
|------------------|----------------------|-----------------|-------------------------|
| K961893 | Duraflor ® | LBH | Pharmascience, Inc. |
| K092141 | 3M Vanish | LBH | 3M ESPE |
| K103160 | Nupro Model 13016901 | LBH | Cao Group, Inc. |
| K132109 | Enamelast | LBH | Ultradent Products, Inc |
- Indication for Use:
StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.
4
Image /page/4/Picture/0 description: The image shows the word "NANOVA" in blue font. The letters are bold and slightly blurred. The background is white.
Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349
Section 5. 510(k) Summary - Cont.
-
- Device Description: StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL.
Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.
- Device Description: StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL.
-
- Substantial Equivalence:
The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:
- Substantial Equivalence:
a) The applicant device has the same intended use as the 510(k) cleared predicates listed above.
b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate devices and other rosin based products currently on the market. This device and its predicates are substantially equivalent in composition and material. StarBright™ 5% Sodium Fluoride Varnish is a paste formulation delivered in unit dose packaging and applied on the tooth surface with a disposable brush, similar to several 510(k) cleared products already on the market.
- 13). Non-clinical performance testing: Non-clinical performance testing on StarBright™ including fluoride release and tubule occlusion support substantial equivalence to the listed predicates. Biological testing included cytotoxicity, sensitization, and irritation. The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
- 14). Clinical performance testing: Clinical performance data was not included.
5
Nanova Biomaterials, Inc. StarBright™ 5% Sodium Fluoride Varnish 510(k) Notification K140349
Section 5. 510(k) Summary - Cont.
Conclusion:
Nanova Biomaterials Inc. believes that StarBrightTM 5% Sodium Fluoride varnish is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.