(125 days)
Expa-syl, Produits Dentaires Pierre Rolland
Not Found
No
The device is a paste containing a hemostatic agent for dental procedures. The description focuses on its physical properties and clinical application, with no mention of AI or ML.
No
The device is described as a hemostatic agent for temporary retraction and hemostasis during dental procedures, not for treating a disease or condition in the long term.
No
The device description and intended use state that it is a paste used for temporary retraction and hemostasis of the gingival margin during dental procedures. It is a tissue management solution, not a tool for diagnosis.
No
The device is described as a paste containing a hemostatic agent, which is a physical substance applied during dental procedures. This clearly indicates it is a physical medical device, 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 temporary retraction and hemostasis of the gingival margin during dental procedures. This is a direct therapeutic or procedural application on the patient's body.
- Device Description: The description reinforces the intended use as a tissue management solution applied directly to the gingival margin.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used to perform tests on samples like blood, urine, or tissue to gain information about a patient's health status. This device is applied directly to the patient's gingival tissue for a procedural purpose.
N/A
Intended Use / Indications for Use
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Product codes (comma separated list FDA assigned to the subject device)
MVL
Device Description
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. TSC is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, TSC will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
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)
Nonclinical Test Data: TSC was tested according to the following biocompatibility studies per ISO 10993-5 and 10993-10: in vitro cytotoxicity, sensitization and oral irritation. The results of the studies are listed in the table below.
Biocompatibility Study: In Vitro Cytotoxicity, Result: Non-cytotoxic
Biocompatibility Study: Sensitization, Result: Elicited no skin reaction / weak allergenic potential
Biocompatibility Study: Oral Irritation, Result: Non-irritant
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of TSC compared to the predicate device, Expo-syl. The characteristics evaluated include viscosity and rinse time.
Clinical Test Data: Clinical testing has not been conducted on this product.
Conclusion: Based upon the biocompatibility test and bench testing, the clinical performance of TSC is substantially equivalent to the predicate device.
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.
Expa-syl, Produits Dentaires Pierre Rolland
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
N/A
0
Image /page/0/Picture/0 description: The image shows a logo with the letters 'sds' in a stylized font. A curved line extends over the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIE' are printed in a simple, sans-serif font. The logo appears to be for a dental company.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
OCT 2 6 2010
Date Summary Prepared: October 2010
Device Name:
- · Trade Name TSC
- · Common Name Gingival Retraction/Hemostatic Paste
- . Classification Name - Unclassified
Device for Which Substantial Equivalence is Claimed:
- · Expa-syl, Produits Dentaires Pierre Rolland
Device Description:
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. TSC is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, TSC will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.
Intended Use of the Device:
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures
1
such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Substantial Equivalence:
TSC is substantially equivalent to another legally marketed device in the United States. TSC functions in a manner similar to Expa-syl, which is currently marketed by Kerr Corporation. TSC is different in formulation from the predicate device in that it contains a glass filler which has been used in numerous other Kerr products. The application and mode of operation is the same for both products.
Nonclinical Test Data:
TSC was tested according to the following biocompatibility studies per ISO 10993-5 and 10993-10: in vitro cytotoxicity, sensitization and oral irritation. The results of the studies are listed in the table below.
| Biocompatibility Study | Result |
|---|---|
| In Vitro Cytotoxicity | Non-cytotoxic |
| Sensitization | Elicited no skin reaction / weak allergenic potential |
| Oral Irritation | Non-irritant |
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of TSC compared to the predicate device, Expo-syl. The characteristics evaluated include viscosity and rinse time.
Clinical Test Data:
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the biocompatibility test and bench testing, the clinical performance of TSC is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kerr Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue Orange, California 92867
Re: K101756
Trade/Device Name: TSC Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: October 13, 2010 Received: October 14, 2010
Dear Ms. Garman:
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 preconaryet 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.
OCT 2 6 2010
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Page 2 – Ms. Garman
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 regencies. 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 (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.
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/CDRHOffices/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 yours,
Susan Runo
Anthony 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
4
Indications for Use
11/01756
510(k) Number (if known):
Device Name: TSC
Indications For Use:
TSC is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
OCT 2 6 2010
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-O1!) Division of Anestnesiology, General Hospital Infection Control. Dental Devices Page 1 of 1 510(k) Number: