(113 days)
Not Found
No
The device description and intended use describe a chemical gel for sulcus retraction and bleeding control, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, ViscoStat Clear, is an aluminum chloride gel used for sulcus retraction and bleeding control in dentistry. It is an auxiliary material that aids in dental procedures, not a device that directly treats or cures a disease or condition in itself.
No
Explanation: The product is described as a chemical agent (aluminum chloride gel) used for sulcus retraction, bleeding control, and easing cord insertion during dental procedures. Its purpose is to physically prepare the area for impression making, not to diagnose a condition or disease.
No
The device description clearly states it is a gel contained within plastic syringes and includes application tips, indicating it is 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 sulcus retraction and controlling bleeding/oozing in the mouth during dental procedures. This is a direct application to the patient's tissues.
- Device Description: The device is a gel applied topically.
- Lack of In Vitro Testing: IVDs are designed to be used on specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status. There is no indication that this device is used for testing specimens in a lab setting.
The device is a therapeutic/procedural aid used directly on the patient during a dental procedure, not a diagnostic tool used on a sample.
N/A
Intended Use / Indications for Use
ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord and/or the Dento Infusor. The gel facilitates the insertion of the cord into the sulcus.
Product codes
MVL
Device Description
ViscoStat Clear is a 25% Aluminum Chloride gel in a viscous, aqueous vehicle which leaves no residue or stain and makes it ideal for use in the esthetic zone. The product is contained within a 30mL or 1.2mL plastic syringe. The 30mL syringe is a bulk container and, prior to application, will be dispensed into provided, empty 1.2mL plastic syringe for delivery to the patient. Dento-Infusor application tips are included and are used to apply the product to the prepared area.
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
Dental professional
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)
Biocompatibility testing shows that the product is safe when used as instructed by a dental professional. In-house comparison testing has been performed on ViscoStat Clear and the predicate device, Racegel. The data supports the functionality of ViscoStat Clear. In summary, this submission demonstrates that ViscoStat Clear is safe and effective and performs equivalently to the identified predicates for its intended use.
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
N/A
0
Image /page/0/Picture/0 description: The image shows a close-up of a black and white graphic. The graphic appears to be a stylized letter or symbol, possibly a 'U' or a part of a larger design. The black areas are solid, while the white areas create the shape of the letter or symbol. The image has a grainy texture, which could be due to the image quality or the texture of the original graphic.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K123215". The characters are written in a simple, cursive style with varying stroke thicknesses. The image is in black and white.
Section 5: 510(k) Summary
FEB 0 5 2013
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant's Name and Address l.
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared: Karen Kakunes, RN Sr. Regulatory Affairs Associate 800-552-5512 x4420, 801-553-4366 801-553-4609 26 Sep 2012
Name of the Device ll.
| Trade Name: | ViscoStat® Clear |
|---|---|
| Common Name: | Cord, Retraction |
| Device Classification: | Unclassified |
| Classification Product Code: | MVL |
| Regulation No. | None |
III. Legally Marketed Predicate Devices to Which Equivalence is Claimed
ViscoStat® Clear is substantially equivalent to Racegel™ (K093711), manufactured by Septodont, which is cleared under dental device product code MVL (cord, retraction). ViscoStat Clear is substantially similar to the predicate device in Indications for Use, chemical composition, mechanical and physical properties and method of application and removal.
IV. Device Description:
ViscoStat Clear is a 25% Aluminum Chloride gel in a viscous, aqueous vehicle which leaves no residue or stain and makes it ideal for use in the esthetic zone. The product is contained within a 30mL or 1.2mL plastic syringe. The 30mL syringe is a bulk container and, prior to application, will be dispensed into provided, empty 1.2mL plastic syringe
1
Image /page/1/Picture/0 description: The image shows a logo with two blocky letters, 'U' and 'F', connected at the top. The letters are bold and black, standing out against a white background. The overall design is simple and modern, with a focus on geometric shapes.
for delivery to the patient. Dento-Infusor application tips are included and are used to apply the product to the prepared area.
V. Statement of intended use:
ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord and/or the Dento Infusor. The gel facilitates the insertion of the cord into the sulcus.
Comparison of technological characteristics VI.
Table 5-1: Substantial equivalence comparison
| Characteristic | Comparison Product | |
|---|---|---|
| (Racegel™ K093711) | ViscoStat Clear | |
| Intended Use | Racegel is a gel containing | |
| aluminum chloride which is | ||
| intended for sulcus retraction prior | ||
| to impression taking; control of | ||
| bleeding and gingival oozing, | ||
| particularly in restorative dentistry; | ||
| and, if using a gingival retraction | ||
| cord, the gel facilitates the insertion | ||
| of the cord into the sulcus | ViscoStat Clear is intended for sulcus | |
| retraction prior to impression | ||
| making and to control bleeding and | ||
| gingival oozing in restorative and | ||
| operative dentistry used with | ||
| gingival retraction cord and/or the | ||
| Dento Infusor. The gel facilitates the | ||
| insertion of the cord into the sulcus. | ||
| Intended user | Dental professional | Dental professional |
| Chemical | ||
| Characteristics | Aluminum chloride gel | Aluminum chloride gel |
| Recommended | ||
| contact time | 2 minutes | 1-3 minutes |
| Delivery system | Pre-filled syringe with applicator tip | 1.2ml pre-filled syringe with |
| applicator tip, 30ml Indispense | ||
| syringe with 1.2ml empty syringe | ||
| and applicator tip | ||
| Physical properties | Orange, odorless gel | Clear gel |
ULTRADENT
PRODUCTS, INC.
2
| 24 month shelf life | 42 month shelf life | |
|---|---|---|
| Biocompatibility | Acute oral toxicity | |
| Sensitization | ||
| Oral Mucosa Irritation | ||
| Cytotoxicity | Cytotoxicity | |
| Functional Testing | Unknown | Aluminum Chloride content |
| Effect on Shear Bond Strength | ||
| Blood coagulation |
ViscoStat Clear is a similar material used in the same way by the same types of users as the identified predicate device Racegel, introducing no new safety or efficacy questions. Biocompatibility testing shows that the product is safe when used as instructed by a dental professional. In-house comparison testing has been performed on ViscoStat Clear and the predicate device, Racegel. The data supports the functionality of ViscoStat Clear. In summary, this submission demonstrates that ViscoStat Clear is safe and effective and performs equivalently to the identified predicates for its intended use.
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 circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2013
Ms. Karen Kakunes, RN Senior Regulatory Affairs Associate Ultradent Products, Incorporated 505 West 10200 South SOUTH JORDAN UT 84095
Re: K123215
Trade/Device Name: ViscoStat® Clear Regulation Number: Unclassified Regulation Name: Cord, Retraction Regulatory Class: Unclassified Product Code: MVL Dated: September 26, 2012 Received: November 7, 2012
Dear Ms. Kakunes:
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 – Ms. Kakunes
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 devicerelated 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,
hor
Theta
Harshita
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Statement of Indications for Use
510(k) Number (if known): ر
Device Name: ViscoStat Clear
Indications for Use: ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative maxing and with gingival retraction cord and/or the Dento Infusor. The gel facilitates the insertion of the cord into the sulcus.
Prescription Use _X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
2013.01.30 Susan Runner DDS, MA 11:55:56 -05'00'
(Posted November 13, 2003)
n Sign-Off)
n of Anesthesiology, General Hospital
n of Anesthesiology, General Devices
510(k) Number: K123213
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