(122 days)
Not Found
No
The device description focuses on the physical and chemical properties of a fluoride varnish system and matrix pads, with no mention of AI or ML technologies.
Yes
The device is described as a "desensitizing agent" intended to treat hypersensitivity in teeth, which constitutes a therapeutic effect.
No
This device is described as a "fluoride containing varnish system intended for use as a desensitizing agent." Its purpose is to treat hypersensitive teeth by applying a varnish and matrix pads, not to diagnose a condition.
No
The device description clearly states it comprises two physical components: Proxivent Varnish and Proxivent Matrix Pads, which are physical materials applied to teeth.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a desensitizing agent on the surface of teeth. This is a therapeutic application directly on the patient's body.
- Device Description: The device is a varnish system and matrix pads applied to the teeth. This is a physical application to a part of the body.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Proxivent Kit does not fit this description.
N/A
Intended Use / Indications for Use
The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.
Product codes
LBH
Device Description
The Proxivent Kit is a fluoride containing variish system intended for use as a desensitizing agent on the surface area of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed. The Proxivent Kit comprises two components, Proxivent Varnish and Proxivent Matrix Pads. The varnish component is intended for application on easily accessible sites such as the buccal and lingual surfaces. The matrix pads include three shapes; round discs; an anatomically H-shaped conformation and an elongated H-shaped conformation (HL). The pads are made of varnishes containing cross-linked gelatin that obdurate dental tubules and release fluoride to strategically targeted tooth surfaces for optimal effects at the microscopic and molecular level at sites not easily accessed. Proxivent matrix pads are small, comfortable devices that denta." professionals can position, for example, between the teeth or at a furcation where there is, or could be, sensitivity. Proxivent matrix pads are engineered to expand gently and lock into place, soften and protect exposed dentin and exude non-toxic micro-doses of fluoride onto and into the tooth crystals (e.g., of the cemetum and dentir ) at inaccessible regions, for example, furcations and between the teeth. The matrix pads biodegrade following their fluoride release.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
denta." professionals
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)
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
Ko73061
Summary of Safety and Effectiveness
FEB 2 9 2008
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter:
Coll Partners Ltd. P.O. Box 14 Telzstone - Qiryat Ye'arim Israel e-mail: drjod(@collvent.com Phone: +972 2 5344829 Fax: +972 2 570 0627
Name of the Device: The Proxivent Kit
Predicate Devices:
The Proxivent kit is substantially equivalent to both Duraflor® dental cavity varnish manufactured by Pharmascience Inc. Canada, subject of K931096, and Duraphat® dental cavity varnish, subject of K931096, manufactured initially by Inpharma and Woclm Pharma in Germany and now manufactured by Colgate Oral Pharmaceuticals Inc.
Description of the Device:
The Proxivent Kit is a fluoride containing variish system intended for use as a desensitizing agent on the surface area of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed. The Proxivent Kit comprises two components, Proxivent Varnish and Proxivent Matrix Pads. The varnish component is intended for application on easily accessible sites such as the buccal and lingual surfaces. The matrix pads include three shapes; round discs; an anatomically H-shaped conformation and an elongated H-shaped conformation (HL). The pads are made of varnishes containing cross-linked gelatin that obdurate dental tubules and release fluoride to strategically targeted tooth surfaces for optimal effects at the microscopic and molecular level at sites not easily accessed. Proxivent matrix pads are small, comfortable devices that denta." professionals can position, for example, between the teeth or at a furcation where there is, or could be, sensitivity. Proxivent matrix pads are engineered to expand gently and lock into place, soften and protect exposed dentin and exude non-toxic micro-doses of fluoride onto and into the tooth crystals (e.g., of the cemetum and dentir ) at inaccessible regions, for example, furcations and between the teeth. The matrix pads biodegrade following their fluoride release.
Hodadhu
on Jodaikin, BDS, MSc, PhD, Ahr Chief Scientist
Oct. 24, 2007
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2008
Coll Partners Limited C/O Dr. Eli M. Orbach General Manager International Regulatory Consultants POB 6718 Efrat, ISRAEL 90435
Re: K073061
Trade/Device Name: Proxivent Kit Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 23, 2008 Received: January 23, 2008
Dear Dr. Orbach:
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.
2
Page 2 - Dr. Orbach
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 (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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
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
3
Indications for Use (separate page):
Page 1 of 1
510(k) Number (if known):
Device Name: Proxivent Kit
Indications For Use:
The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.
rescription Use AND/OR art 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER AGE IF NEEDED)
oncurrence of CDRH, Office of Device Eyaluation (ODE)
Susan Turner
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. KC7346
FDA Application