(43 days)
No
The summary describes a chemical desensitizer product and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the rapid relief of hypersensitivity (a medical condition) and promotes clinical healing, indicating a therapeutic effect.
No
The device is described as a "SULTAN TOOTH ROOT DESENSITIZER" intended for "rapid relief of hypersensitivity associated with exposed tooth root dentin." Its function is therapeutic (desensitizing and promoting healing), not diagnostic. There is no mention of it being used to identify, measure, or monitor a disease or condition.
No
The device description clearly states it is a "two-phase product" and mentions manufacturing and relabeling/repackaging, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "rapid relief of hypersensitivity associated with exposed tooth root dentin." This is a direct treatment applied to the tooth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description states it's a "two-phase product designed to minimize sensitivity and promote clinical healing following periodontal debridement." This further reinforces its function as a therapeutic or treatment device applied directly to the affected area.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
Therefore, SULTAN TOOTH ROOT DESENSITIZER is a therapeutic dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SULTAN TOOTH ROOT DESENSITIZER is intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin.
Product codes
LBH
Device Description
SULTAN TOOTH ROOT DESENSITIZER is identical to the predicate devices. This product is manufactured by Novamin Technology Inc. and is then relabelled/repackaged. SULTAN TOOTH ROOT DESENSITIZER is a two-phase product designed to minimize sensitivity and promote clinical healing following periodontal debridement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth root dentin
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)
SULTAN TOOTH ROOT DESENSITIZER was tested for toxicity, irritation, and sensitization and found to be biocompatible.
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
2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street. Suite 60 York, PA 17405-0872
DATE PREPARED: August 17, 2007 Helen Lewis CONTACT: SULTAN TOOTH ROOT DESENSITIZER TRADE OR PROPRIETARY NAME: CLASSIFICATION NAME: 872.3260 Cavity varnish
PREDICATE DEVICES: PerioSRP™ Tooth Root Conditioner with NovaMin® K071267 Butler NuCare® Root Conditioner with NovaMin® K033295
DEVICE DESCRIPTION: SULTAN TOOTH ROOT DESENSITIZER is identical to the predicate devices. This product is manufactured by Novamin Technology Inc. and is then relabelled/repackaged. SULTAN TOOTH ROOT DESENSITIZER is a two-phase product designed to minimize sensitivity and promote clinical healing following periodontal debridement.
INTENDED USE: SULTAN TOOTH ROOT DESENSTIZER is intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in SULTAN TOOTH ROOT DESENSITIZER have been used in the legally marketed predicate devices.
SULTAN TOOTH ROOT DESENSITIZER was tested for toxicity, irritation, and sensitization and found to be biocompatible.
SULTAN TOOTH ROOT DESENSITIZER is the same product as the legally marketed devices. We believe this fact supports the safety and effectiveness of SULTAN TOOTH ROOT DESENSITIZER.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
2007
Re: K072342
Trade/Device Name: Sultan Tooth Root Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 17, 2007 Received: August 21, 2007
Dear Ms. Lewis:
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- Ms. Lewis
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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 STATEMENT
07-2342 510(k) Number (if known):
SULTAN TOOTH ROOT DESENSITIZER Device Name:
Indications for Use:
SULTAN TOOTH ROOT DESENSITIZER is intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Rumppes
ision Sign-Off) reston of Sign=Oil)
Vision of Anesthesiology, General Hospital, Information of Anesthesiology, Gene
510(k) Number:
000010