(210 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a cavity varnish, with no mention of AI or ML.
Yes
The device is indicated for the "treatment of hypersensitive teeth," which is a therapeutic purpose.
No
This device is described as a cavity varnish for coating exposed dentin and treating hypersensitive teeth. It is a treatment material, not a diagnostic tool used to identify or analyze a condition.
No
The device description clearly states it is a "cavity varnish" which is a physical material applied to teeth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ascent F-Coat is a varnish applied directly to tooth surfaces and exposed dentin in vivo (within the body). It is a treatment for hypersensitivity and a coating under temporary restorations.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is a direct application to the anatomical site.
Therefore, the description clearly indicates a device used for direct treatment and coating on the tooth, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
Ascent F-Coat is indicated for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
The Ascent F-Coat cavity varnish is an ethanol based varnish agent containing 5% sodium fluoride. The material is applied to tooth surfaces where hypersensitivity is a concern The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-I he varilish is upplication of temporary restorative materials. The material is a white opaque treamient prof to upprication of temperation of the present of in preloaded dispensing syringes with disposable brush tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, tooth surfaces, exposed dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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)
Laboratory testing demonstrates that the subject device contains fluoride ion at the labeled concentration of 5% or 22,600ppm and is at least equivalent to the predicate devices which share similar labeled fluoride content.
Share Simmar Robers nates that the subject device provides adhesion to the tooth of 77kPa.
Photomicrographs of the subject device reveal that it is capable of penetrating exposed dentin tubules to a minimum of 3-5 microns.
Laboratory dye penetration tests demonstrate that the subject device is substantially equivalent to the predicate devices in preventing the ingress of fluids into the exposed dentin tubules.
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/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '100540'. The handwriting is somewhat cursive, with the numbers and letters connected to each other.
510(k) Summary of Safety and Effectiveness
CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801-256-9282 Fax: 801-256-9287
Robert Larsen, Preparation Date: August 23, 2010
Device Name:
| Trade Name: | Ascent F-Coat |
|---|---|
| Common Name: | Cavity Varnish |
| Product Classification: | Varnish, Cavity |
Legally Marketed Predicate Devices for Substantial Equivalence:
Vanish Varnish, manufactured by 3M Company (K090519)
DuraShield, manufactured by Dentsply International, Inc. (K082198)
Rationale for Substantial Equivalence:
The aforementioned varnishes share similar indications for use on teeth for alleviating hypersensitivity with the submitted device. The predicate devices and submitted device share similar design features including the incorporation of sodium fluoride and carrier solvents, application time and application methods.
Description of Submitted Device:
The Ascent F-Coat cavity varnish is an ethanol based varnish agent containing 5% sodium fluoride. The material is applied to tooth surfaces where hypersensitivity is a concern The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-I he varilish is upplication of temporary restorative materials. The material is a white opaque treamient prof to upprication of temperation of the present of in preloaded dispensing syringes with disposable brush tips.
SEP 2 3 2010
5-1
1
Intended Uses of Ascent F-Coat:
The device is intended for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.
Technological Characteristics and Substantial Equivalence:
The Vanish Varnish is a 5% sodium fluoride varnish containing a total 22,600ppm equivalent fluoride ion. The varnish uses an ethanol carrier and makes use of natural resin equiratives as the variish matrix. The product is intended for use by a dentist for the treatment of hypersensitivity, for use on exposed dentin, and under temporary dental restorations. The material is packaged in unit-dose blister packs and is applied by a disposable brush.
The Durashield Varnish is a 5% sodium fluoride varnish containing a total 22,600ppm equivalent fluoride ion. The varnish uses an ethanol carrier and makes use of natural resin derivatives as the varnish matrix. The product is intended for use by a dentist for the relief of hypersensitivity where exposed dentin or cement, exist. The material is packaged in unit-dose blister packs and is applied by a disposable brush.
Conformity to Standards:
The Ascent F-Coat cavity varnish was evaluated in terms of the recognized standard ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
Performance Data
Laboratory testing demonstrates that the subject device contains fluoride ion at the labeled concentration of 5% or 22,600ppm and is at least equivalent to the predicate devices which share similar labeled fluoride content.
Share Simmar Robers nates that the subject device provides adhesion to the tooth of 77kPa.
a.
Photomicrographs of the subject device reveal that it is capable of penetrating exposed dentin tubules to a minimum of 3-5 microns.
Laboratory dye penetration tests demonstrate that the subject device is substantially equivalent to the predicate devices in preventing the ingress of fluids into the exposed dentin tubules.
2
The Ascent F-Coat cavity varnish is substantially equivalent to the listed cavity varnishes without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Larsen Regulatory Affairs Manager CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084
SEP 2 3 2010
Trade/Device Name: Ascent F-Coat Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish
Regulatory Class: II Product Code: LBH Dated: August 30, 2010 Received: September 3, 2010
Dear Mr. Larsen:
Re: K100540
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- Mr. Larsen
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division.of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
100540 SEP 2 3 2010
KID 0540 510(k) Number (if known):
Device Name: Ascent F-Coat
Indications For Use:
Ascent F-Coat is indicated for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.
Over-The-Counter Use AND/OR Prescription Use X (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Puons
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100340
Page 1 of 1