(11 days)
Not Found
No
The summary describes a dental varnish and explicitly states that mentions of AI, DNN, or ML were not found. The device description focuses on material composition and intended use, not computational capabilities.
No
The device is a varnish intended to seal dentinal tubules and improve restorations, not to treat a disease or condition. Its purpose is supportive rather than therapeutic.
No.
The device description indicates its use is for sealing dentinal tubules and improving restorations, acting as a varnish rather than to diagnose medical conditions.
No
The device description clearly indicates it is a "modified varnish," which is a physical substance applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product applied directly to teeth and dentin to address sensitivity and improve restorations. This is a direct application to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the composition and properties of a varnish, not on a system designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for in vivo use (applied to the living body) rather than in vitro use (performed outside the living body).
N/A
Intended Use / Indications for Use
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
Product codes
LBH
Device Description
The modified varnish has the following similarities to that which previously received 510(k) concurrence:
- Has the same active ingredient at the same concentration; .
- has the same indications for use; .
- incorporate the same or similar materials; .
- has the same shelf life, and; ●
- is packaged using the same materials and processes.
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
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)
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
Image /page/0/Picture/0 description: The image shows the logo for Pascal Company, Inc. The logo consists of a stylized letter "P" on the left, followed by the word "Pascal" in a bold font. Below the word "Pascal" is the phrase "Company, Inc." in a smaller font. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
MAR 1 6 2009
510(k) Summary (as required by section 807.92c)
Reference
Premarket Approval Number: K030488 Trade/Device Name: Fluorilaq Sodium Fluoride Cavity Varnish Date of Concurrence: May 2, 2003
Submitted by
Vincent M. Tentarelli Pascal Company, Inc. 2929 NE Northup Way Bellevue, WA 98004 USA
- Establishment Registration No. 3011632
Date Prepared
Device Trade Name
DEVICE LIKE NEW
Regulation Number
Device Common Name
Regulatory Name
Substantial Equivalence
Regulatory Class
Product Code
Class II
March 4, 2009
21 CFR 872.3260
Dental Varnish
Cavity Varnish
LBH
The modified varnish has the following similarities to that which previously received 510(k) concurrence:
- Has the same active ingredient at the same concentration; .
- has the same indications for use; .
Fluorilaq Sodium Fluoride Cavity Varnish
- incorporate the same or similar materials; .
- has the same shelf life, and; ●
- is packaged using the same materials and processes.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized eagle emblem with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
MAR 1 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Incorporated 2929 North East Northup Way Bellevue, Washington 98004
Re: K090597
Trade/Device Name: Fluorilaq Sodium Fluoride Cavity Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Codes: LBH Dated: March 4, 2009 Received: March 5, 2009
Dear Mr. Tentarelli:
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 - Mr. Tentarelli
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Suigte Y. Mohan Dass.
Ginette Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image contains a logo for Pascal Company, Inc. The logo consists of a stylized letter "P" on the left, with the word "Pascal" in a sans-serif font to the right. Below "Pascal" is the text "Company, Inc." in a smaller font size. The logo appears to be in black and white.
Attachment 2: Indications for Use Statement
Reference
Premarket Approval Number: K030488 Trade/Device Name:
Fluorilaq Sodium Fluoride Cavity Varnish Date of Concurrence: May 2, 2003
240 59 -
510(k) Number (if known):
Device Name:
Fluorilaq Sodium Fluoride Cavity Varnish
Indications for Use:
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
Over-The-Counter Use
0405
Kein Mulvey Sor M.IR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
OR