(384 days)
Not Found
Not Found
No
The summary describes a chemical gel for treating tooth sensitivity and does not mention any computational or data-driven components indicative of AI/ML.
Yes
Explanation: The device is intended to treat dentin sensitivity by sealing dentinal tubules, which is a therapeutic function.
No
The device is a desensitizing gel used for treatment, not for diagnosing a condition. Its indications for use describe the target problem (dentin sensitivity) and resolution (sealing dentinal tubules), without mentioning any diagnostic capabilities.
No
The device is a gel, which is a physical substance, not software. The description clearly outlines its chemical composition and physical form.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The UltraEZ Desensitizing Gel is applied directly to the teeth to treat sensitivity. It works by physically sealing dentinal tubules. It does not analyze samples taken from the body.
- Intended Use: The intended use is for treating dentin sensitivity, not for diagnosing a condition based on analyzing biological samples.
Therefore, this device falls under the category of a therapeutic dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Composed of potassium nitrate and fluoride ions in a film-like varnish. 3% Potassium Nitrate and 0.11% w/w Fluoride Ion Gel for the treatment of dentin sensitivity. For professional dental use. Immediate physical blockage of dentinal tubules to eliminate painful sensitivity. Designed to be used in a custom-fabricated dental tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth / Dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
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): 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.
Not Found
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/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" shape on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, thinner font. The overall design is simple and professional, conveying a sense of reliability and innovation.
SUMMARY REPORT AND STATEMENT OF COMPARISON
INTRODUCTION:
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 and supports the conclusion of SE for UltraEZ Desensitizing Gel noted below.
1. Applicant's Name and Address:
Ultradent Products, Inc. 505 West 10200 South South Jordan, Utah 84095 Telephone number: 801-553-4323 Fax number: 801-572-0600 Contact Person: Tammy Lavery Regulatory Affairs Senior Manager
Device Information: 2.
| Classification: | Class II |
|---|---|
| Regulation: | 872.3260 |
| Trade Name: | UltraEZ Desensitizing Gel |
| Common Name: | Tooth Desensitizer |
| Classification Name: | Varnish, Cavity |
| Classification Code: | LBH |
| Classification Panel: | Dental |
3. Indications for Use:
The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
4. Predicate Device Description & Statement of Comparison to Predicate Device:
UltraEZ Desensitizing Gel which is to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, Utah 84095, is substantially equivalent to the legally - marketed device(s): Cosmedent Tooth Desensitizer marketed by Cosmedent, Inc., 401 N. Michegan Avenue, Ste 2500, Chicago, IL 60611, and Protect marketed by Sunstar Butler Refer, 4635 West Foster Avenue, Chicago, IL 60630. Refer to the comparison table below.
1
Image /page/1/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" and "E" combined into a single graphic on the left. To the right of the graphic is the word "ULTRADENT" in bold, sans-serif font. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, sans-serif font.
Product Description Similarities:
| UltraEZ Desensitizing Gel | Cosmedent Desensitizing Gel | Protect Desensitizing Gel |
|---|---|---|
| Composed of potassium nitrate | ||
| and fluoride ions in a film-like | ||
| varnish. | Composed of potassium nitrate | |
| and fluoride ions in a film-like | ||
| varnish. | Composed of potassium and | |
| fluoride ions in a film-like varnish. | ||
| 3% Potassium Nitrate and 0.11% | ||
| w/w Fluoride Ion Gel for the | ||
| treatment of dentin sensitivity. | 3% Potassium Nitrate and 1200 | |
| ppm Fluoride Ion Gel for the | ||
| treatment of dentin sensitivity. | Ingredients: Ethanol, water, | |
| hydroxypropylcellulose, potassium | ||
| fluoride, polyethylene glycol, | ||
| dimethacrylate, methacrylates. | ||
| For professional dental use. | For professional dental use. | For professional dental use. |
| Immediate physical blockage of | ||
| dentinal tubules to eliminate | ||
| painful sensitivity. | Immediate physical blockage of | |
| dentinal tubules to eliminate | ||
| painful sensitivity. | Immediate physical blockage of | |
| dentinal tubules to eliminate | ||
| painful sensitivity. |
Product Description Differences:
| UltraEZ Desensitizing Gel | Cosmedent Desensitizing Gel | Protect Desensitizing Gel |
|---|---|---|
| Designed to be used in a custom- | ||
| fabricated dental tray. | Designed to be tray delivered or | |
| may be brushed directly on the | ||
| affected area: | Designed to be brushed directly on | |
| the affected area. |
CONCLUSION:
Ultradent deems the UltraEZ Desensitizing Gel to be substantially equivalent and equally safe and effective as that of the predicates: Cosmedent's Tooth Desensitizer and Sunstar Butler's Protect Tooth Desensitizer per comparison noted above.
Tammy Lavery
Tammy Laver Regulatory Affairs Senior Manager Submitter and Contact 800 552-5512 extension 4323 or direct 801 553-4323 fax 801 553-4609 or 801 572-0600 email: Itamara@ultradent.com
Aug 7, 2006
Date
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
JUN 1 2 2007
Re: K061438
Trade/Device Name: UltraEZ Desensitizing Gel Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 8, 2007 Received: June 11, 2007
Dear Ms. Lavery:
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 such 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.
3
Page 2 - Ms. Lavery
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. ·
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Gunner
O Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): Unknown
Device Name: UltraEZ Desensitizing Gel
Indications for use:
The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The-Counter Use:_
(Optional Format 1-2-96)
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