(395 days)
No
The device description and performance studies focus on the chemical and physical properties of a dental varnish, with no mention of AI or ML technologies.
Yes
This device is intended to treat hypersensitive teeth and exposed dentin/root sensitivity, which are therapeutic claims.
No
Explanation: The device description states its purpose is to treat hypersensitive teeth and seal dentin tubules for immediate relief. It does not mention any function related to diagnosing conditions or identifying diseases.
No
The device description clearly states it is a "fluoride & calcium releasing varnish," which is a physical substance applied to teeth, 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 to treat hypersensitive teeth and exposed dentin/root sensitivity. This is a therapeutic treatment applied directly to the patient's teeth.
- Device Description: The device is a varnish applied to enamel and dentin. It works by releasing fluoride and calcium to seal dentin tubules and provide relief. This is a direct treatment, not a diagnostic test performed on a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to diagnose a condition. The device's function is purely therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Treats hypersensitive teeth
- Treats exposed dentin and root sensitivity
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
FluoroCal is a fluoride & calcium releasing varnish with Tri-Calcium Phosphates (TCP) for application to enamel and dentin for the treatment of hypersensitive teeth. FluoroCal delivers targeted and sustained release of fluoride & calcium over 24 hours. This varnish penetrates and seals dentin tubules, providing immediate relief of sensitivity. Available in Spearmint; sweetened with Xylitol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin / tooth surfaces / dentin tubules
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)
The following physical/mechanical properties of FluoroCal were tested:
- Fluoride Content (ISO 17730:2014(E)): FluoroCal meets the requirements of the standard and is equivalent to the predicates.
- Consistency (ANS/ADA Spec #8 4.3.2): FluoroCal is equivalent to the predicates.
- pH: FluoroCal is equivalent to the predicates.
- Calcium Release: FluoroCal is equivalent to the predicates.
- Fluoride Release: FluoroCal is equivalent to the predicates.
- SEM Tubule Occlusion: FluoroCal is equivalent to the predicates.
Biocompatibility: An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of FluoroCal. It is concluded from the safety evaluation and the results of the Oral Toxicity testing that FluoroCal meets the requirements of the testing.
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.
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
§ 872.3260 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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November 18, 2019
Bisco, Inc Ryan Hobson RA Product Registration Manager 1100 W Irving Park Rd Schaumburg, Illinois 60193
Re: K182917
Trade/Device Name: FluoroCal Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: October 18, 2019 Received: October 24, 2019
Dear Ryan Hobson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182917
Device Name FluoroCal
Indications for Use (Describe)
-
Treats hypersensitive teeth
-
Treats exposed dentin and root sensitivity
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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/1 description: The image shows the logo for BISCO. The logo consists of a series of red and blue hexagons connected together in a chain-like pattern. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.
510(k) SUMMARY
Applicant:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143
18 October 2019
Date Prepared:
Trade Name: Common Name: Product Code: Classification/Name: FluoroCal 5% Sodium Fluoride Varnish with Tri-Calcium Phosphate LBH Cavity Varnish Class II per 21 CFR 872.3260
Predicate Devices:
FluoroCal is substantially equivalent to:
Primary Predicate: Vanish Varnish, 5% Sodium Fluoride White Varnish by 3M ESPE Dental Products - K092141 Reference Predicate: MI Varnish, by GC America Inc. - K102808
Indications for Use:
-
- Treats hypersensitive teeth
-
- Treats exposed dentin and root sensitivity
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A. 800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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K182917
Image /page/4/Picture/1 description: The image shows the BISCO company logo. The logo consists of a series of red and blue hexagons arranged in a curved line above the word "BISCO". The word "BISCO" is written in a bold, sans-serif font, with the letters "BI" in gray and the letters "SCO" in black.
510(k) SUMMARY (continued)
Indications for Use
The indications for use of FluoroCal are similar as those for the primary predicate and the reference predicate and are summarized in the table below:
| Vanish Varnish White (K092141) | MI Varnish (K102808) | FluoroCal |
|---|---|---|
| • Treatment of hypersensitive | ||
| teeth | ||
| • Use on exposed dentin and | ||
| root sensitivity | ||
| • Under temporary restoratives | ||
| and cements where post- | ||
| operative sensitivity is of | ||
| concern | MI Varnish is a fluoride | |
| varnish with Recaldent™ | ||
| (CPP-ACP) that has a | ||
| desensitizing action when | ||
| applied to tooth surfaces. The | ||
| application leaves a film of | ||
| varnish on tooth and this may | ||
| allow visual control and | ||
| verification. | 1. Treats hypersensitive teeth |
- Treats exposed dentin and
root sensitivity |
The only difference between FluoroCal and the primary predicate device is that FluoroCal is not indicated for use under temporary restoratives. Both of FluroCal's indications are identical to the first two indications of the primary predicate. Fluorocal's indications are similar to the reference predicate in that they both treat sensitization on tooth surfaces.
Description of Applicant Device:
FluoroCal is a fluoride & calcium releasing varnish with Tri-Calcium Phosphates (TCP) for application to enamel and dentin for the treatment of hypersensitive teeth. FluoroCal delivers targeted and sustained release of fluoride & calcium over 24 hours. This varnish penetrates and seals dentin tubules, providing immediate relief of sensitivity. Available in Spearmint; sweetened with Xylitol. 1 As tested in deionized water.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/5/Picture/1 description: The image shows the logo for BISCO. The logo features a series of five connected, three-dimensional hexagons in red and blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.
510(k) SUMMARY (continued)
Technological Characteristics:
All components of FluoroCal are based upon industry standard chemistry. The chemical composition of FluoroCal is similar to Vanish Varnish (K092141) and MI Varnish (K102808) summarized in the table below:
| Chemical
Composition | Vanish Varnish White
(K092141) | MI Varnish (K102808) | FluoroCal |
|-------------------------|-----------------------------------|------------------------|-----------------------------|
| Rosin | Hydrogenated Rosins | Hydrogenated Rosins | Hydrogenated Rosins |
| Solvent | n-Hexanes, Ethanol | Ethoxyethanol; Ethanol | Triethylene glycol; Ethanol |
| Ion release | Fluoride, Calcium | Fluoride, Calcium | Fluoride, Calcium |
| Physical Mechanical
Property | Vanish Varnish White
(K092141) | MI Varnish (K102808) | FluoroCal |
|---------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|
| Fluoride Content | Meets requirements of
ISO 17730:2014(E) | Meets requirements of
ISO 17730:2014(E) | Meets requirements of
ISO 17730:2014(E) |
| Consistency | Non-clumping | Non-clumping | Non-clumping |
| pH | 6 | 6.2 | 6.4 |
| Calcium Release | Releases Calcium | Releases Calcium | Releases Calcium |
| Fluoride Release | Releases Fluoride | Releases Fluoride | Releases Fluoride |
| Tubule Occlusion | Occludes dentin tubules | Occludes dentin tubules | Occludes dentin tubules |
| Delivery system | Foil pouch | Blister package | Blister package |
Performance Data:
The following physical/mechanical properties of FluoroCal were tested:
| Physical / Mechanical Property | FluoroCal |
|---|---|
| Fluoride Content | |
| (ISO 17730:2014(E) | FluoroCal meets the requirements of the standard and is equivalent to the predicates. |
| Consitency (ANS/ADA Spec #8 4.3.2) | FluoroCal is equivalent to the predicates. |
| pH | FluoroCal is equivalent to the predicates. |
| Calcium Release | FluoroCal is equivalent to the predicates. |
| Fluoride Release | FluoroCal is equivalent to the predicates. |
| SEM Tubule Occlusion | FluoroCal is equivalent to the predicates. |
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of FluoroCal. It is concluded from the safety evaluation and the results of the Oral Toxicity testing that FluoroCal meets the requirements of the testing.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that FluggOCal is substantially equivyalentings and productions and effectiveness to the predicate device.