(116 days)
Not Found
No
The description focuses on the chemical composition and delivery mechanism of a fluoride varnish, with no mention of AI or ML.
Yes
The device is described as "producing a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity," indicating a therapeutic effect.
No
This device is a fluoride varnish intended for the treatment of tooth hypersensitivity by mechanically occluding dentinal tubules. Its function is therapeutic, not diagnostic.
No
The device description clearly indicates a physical product (varnish, blister pack, syringe, applicator brushes) and its intended use is a physical treatment (mechanical occlusion of dentinal tubules). There is no mention of software as the primary or sole component.
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 tooth hypersensitivity by mechanically occluding dentinal tubules. This is a therapeutic action performed directly on the patient's tooth.
- Device Description: The device is a fluoride varnish applied to the tooth surface.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is applied to the body for a therapeutic effect.
N/A
Intended Use / Indications for Use
Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.
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
Dental professional
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)
In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF. The data supports the functionality of Enamelast.
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
§ 872.3260 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 a stylized logo in black. The logo appears to be a combination of the letters 'U' and 'R' in a bold, blocky font. The 'U' is on the left, and the 'R' is formed by a vertical line extending from the top of the 'U' and a horizontal line extending from the middle of the 'U'. There is a small circle in the upper right corner of the logo.
Section 7: 510(k) Summary
This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
l. Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
NOV 0 1 2013
| Contact Person: | Karen Kakunes, RN |
|---|---|
| Title: | Sr. Regulatory Affairs Associate |
| Telephone: | 800-552-5512 x4366, 801-553-4366 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | 28 June 2013 |
11. Name of the Device
| Trade Name: | Enamelast™ |
|---|---|
| Common Name: | Cavity Varnish |
| Device Classification: | Class II |
| Classification Product Code: | LBH |
| Regulation No. | CFR 872.3260 |
III. Device Description:
Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.
IV. Statement of intended use:
Enamelast™Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
1
Image /page/1/Picture/0 description: The image shows a stylized logo in black against a white background. The logo appears to be a monogram, possibly representing two letters or initials that are interconnected. The design is geometric with rounded corners, giving it a modern and abstract look. A small superscript letter 'G' is positioned at the upper right corner of the logo.
Comparison of technological characteristics V.
Table 7-1: Substantial equivalence comparison
| Characteristic | Comparison Product | |
|---|---|---|
| (Flor-Opal Varnish White K080249) | Enamelast™ | |
| Intended Use | Flor-Opal Varnish White is 5% sodium | |
| fluoride in a varnish carrier which | ||
| produces a mechanical/chemical | ||
| occlusion of the dentinal tubules in | ||
| the treatment of tooth | ||
| hypersensitivity. | Enamelast™ Fluoride Varnish is 5% sodium | |
| fluoride in a varnish carrier which produces a | ||
| mechanical occlusion of the dentinal tubules in | ||
| the treatment of tooth hypersensitivity. | ||
| Intended user | Dental professional | Dental professional |
| Chemical | ||
| Characteristics | 5% sodium fluoride | |
| Resin based | 5% sodium fluoride | |
| Resin based | ||
| Delivery system | Syringe-to-syringe mixing system with | |
| applicator tip | 1.2 mL pre-filled syringe ; 0.4mL unit dose | |
| blister pack with applicator brush | ||
| Physical properties | Appearance: White resinous material | |
| Odor: Bubble gum or Mint | Appearance: A white resinous material Odor: | |
| Mint or Walterberry (strawberry/amaretto) | ||
| pH: Mint - 2.95 | pH: Mint - 3.9; Walterberry - 3.9 | |
| Shelf Life: 18 months | Shelf Life: 24 months | |
| Biocompatibility | Cytotoxicity | Cytotoxicity |
| Oral Mucosa Irritation | ||
| Genotoxicity | ||
| Sensitization | ||
| Functional Testing | Film Thickness | Fluoride uptake |
| Fluoride varnish retention | ||
| Film Thickness |
Enamelast is a similar material used in the same way by the same types of users as the identified predicate device Flor-Opal Varnish White, introducing no new major safety or efficacy questions.
Image /page/1/Picture/5 description: The image shows the logo for Ultradent Products, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The word "ULTRADENT" is on the top line, and "PRODUCTS, INC." is on the bottom line. The logo is simple and professional.
2
Image /page/2/Picture/0 description: The image shows a stylized logo with two blocky, interconnected shapes. The shape on the left resembles a 'U', while the shape on the right resembles a 'P'. The shapes are bold and solid, with rounded corners, giving the logo a modern and geometric appearance. A small trademark symbol is visible in the upper right corner of the logo.
Biocompatibility testing shows that the product is safe when used as instructed by a dental professional. In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF. The data supports the functionality of Enamelast.
In summary, this submission demonstrates that Enamelast is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicate and comparable product for its intended use.
Image /page/2/Picture/4 description: The image shows the logo for Ultradent Products, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The letters 'UP' are stacked on top of each other on the left side of the logo. The words 'PRODUCTS, INC.' are written in a smaller font below the company name.
W.U.STACTERN 800 - 57 45
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Ultradent Products, Incorporated Ms. Karen Kakunes Senior Regulatory Affairs Associate 505 West 10200 South South Jordan, UT 84095
Re: K132109
Trade/Device Name: Enamelast™ Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 17, 2013 Received: July 24, 2013
Dear Ms Kakunes:
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.
4
Page 2 - Ms. Kakunes
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MarySBunner-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 6: Statement of Indications for Use
510(k) Number (if known): K132109
Device Name: Enamelast™
Indications for Use: Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
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)
Page 1 of 1
Andrer
(Posted November 13, 2003)