(183 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a fluoride varnish, with no mention of AI or ML.
Yes
The device is described as a "fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity," indicating its use in treating a medical condition.
No
Explanation: The device is a fluoride-containing preparation for treatment of dentinal hypersensitivity and reduction of post-operative sensitivity. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a fluoride-containing preparation (a substance) and includes an applicator and packaging, indicating it is a physical product, 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 treatment of dentinal hypersensitivity and reduction of post-operative sensitivity. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a fluoride-containing preparation applied to teeth. This is a topical treatment, not a test performed on biological samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Product codes
LBH
Device Description
Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post-operative sensitivity. 1mL of varnish contains 50 mg of sodium fluoride, equivalent to 22.6 mg fluoride ion. Varnish is sweetened with sucralose and Xylitol, and flavored. Varnish and applicator are packaged together in a molded opaque acclar tray, and sealed with a metallized foil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/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
Performance - Comparative bench testing with the predicate was carried out by independent laboratories. Bench testing confirmed that the fluoride release and tubule occlusion characteristics of Oral-B varnish are as expected and comparable to the predicate. Shelf Life – The shelf life of this device is declared to be 24 months in accordance with defined protocols and acceptance specifications and have provided the rationale for establishment of this shelf life. Biocompatibility - Oral-B varnish and the predicate were tested for cytotoxicity per ISO 10993-5 with equivalent results. Oral-B varnish was also tested for irritation and sensitization per ISO 10993-10. Test results provide evidence of biocompatibility. Clinical data were not needed for these devices to show substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Young Dental Manufacturing Co 1, LLC. Ms. Sarah Moore Director of Quality and Regulatory Affairs 13705 Shoreline Ct. East Earth City, Missouri 63045
Re: K153334
Trade/Device Name: Oral-B 5% Sodium Fluoride Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 14, 2016 Received: April 18, 2016
Dear Ms. Moore:
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.
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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 of medical devicerelated 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina Kiang -
for 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
Enclosure
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Indications for Use
510(k) Number (if known) K153334
Device Name Oral-B 5% Sodium Fluoride Varnish
Indications for Use (Describe)
Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The letters are spaced closely together, creating a solid block of text. A small trademark symbol is located to the right of the letter "G".
510(k) Summary K153334
| Sponsor: | Young Dental Manufacturing Co. 1 LLC
13705 Shoreline Ct. East
Earth City, MO 63045 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sarah Moore
Quality/Regulatory Affairs
Telephone: 314-372-8040
Fax: 314-344-0021 |
| Date: | May 06, 2016 |
| Trade Name: | Oral-B 5% Sodium Fluoride Varnish |
| Common Name: | Cavity Varnish |
| Classification Names
and References: | Varnish, Cavity
21 CFR 872.3260, LBH |
| Classification Panel: | Dental |
| Predicate Device(s): | VarnishAmerica 5% Sodium Fluoride Varnish, Medical
Products Laboratories, Inc. K040098, cleared February 4,
2004 |
| Purpose and Description | Oral-B 5% Sodium Fluoride Varnish is a fluoride-
containing preparation for the treatment of dentinal
hypersensitivity, and for the reduction of post-operative
sensitivity. 1mL of varnish contains 50 mg of sodium
fluoride, equivalent to 22.6 mg fluoride ion. Varnish is
sweetened with sucralose and Xylitol, and flavored.
Varnish and applicator are packaged together in a molded
opaque acclar tray, and sealed with a metallized foil. |
| Intended Use: | Oral-B varnish is a fluoride-containing preparation for the
treatment of dental hypersensitivity, and for the reduction
of post-operative sensitivity. |
| Technological Characteristics | The fundamental principle and primary mode of action of
both the Oral-B varnish and the predicate in reducing |
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Image /page/4/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a trademark symbol to the right of the word.
dental hypersensitivity is the occlusion of open dentin tubules. Oral-b and the predicate exist as a viscous liquid that is able to be applied to the teeth using a brush or similar applicator. Both the Oral-B and the predicate employ 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride which occludes the dentin tubules. Both use denatured alcohol as a significant component, providing fluidity for application and to promote quick drying on the tooth surface.
The technological difference between the Oral-B varnish and the predicate is the formulation of components. The Oral-B varnish uses a synthetic resin as the base material instead of the natural rosin used in the predicate. Oral-B also includes an additional base material, sweeteners, and flavoring agents.
Comparison to Predicate Device:
The table below summarizes the similarities and differences between Oral-B 5% Sodium Fluoride Varnish and the predicate device:
| | Oral-B 5% Sodium Fluoride
Varnish | VarnishAmerica 5% Sodium
Fluoride Varnish-
Predicate Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | K153334 | K040098 |
| Indications for use | Treatment of dental
hypersensitivity and Reduction
of post-operative sensitivity | Treatment of dental hypersensitivity
and Reduction of post-operative
sensitivity |
| Contraindications | Ulcerative gingivitis and
stomatitis | Ulcerative gingivitis and stomatitis |
| Mode of action | Dentin Tubule Occlusion | Dentin Tubule Occlusion |
| Method of application | Application of a thin coat of
varnish on tooth surfaces | Application of a thin coat of varnish
on tooth surfaces |
| Percentage of sodium
fluoride | 5% | 5% |
| Packaging | Varnish and applicator brush
placed in a molded opaque
acclar tray and closed with a
foil seal | Varnish and applicator brush placed
in a molded opaque acclar tray and
closed with a foil seal |
| Unit package | 0.4mL | 0.4mL |
| Base Material | Synthetic Rosin | Natural Rosin |
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Image /page/5/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A small trademark symbol is located to the right of the letter "G".
Fluoride Release and Dentin Tubule Occlusion Performance Data (Nonclinical): Performance - Comparative bench testing with the predicate was carried out by independent laboratories. Bench testing confirmed that the fluoride release and tubule occlusion characteristics of Oral-B varnish are as expected and comparable to the predicate. . Shelf Life – The shelf life of this device is declared to be 24 months in accordance with defined protocols and acceptance specifications and have provided the rationale for establishment of this shelf life. . Biocompatibility - Oral-B varnish and the predicate were tested for cytotoxicity per ISO 10993-5 with equivalent results. Oral-B varnish was also tested for irritation and sensitization per ISO 10993-10. Test results provide evidence of biocompatibility. Performance Data (Clinical): Clinical data were not needed for these devices to show substantial equivalence. Conclusions: The information presented in this submission including composition and indications for use, together with biocompatibility and non-clinical performance testing establish that Oral-B varnish is substantially equivalent to the predicate.