VISCOSTAT CLEAR

K123215 · Ultradent Products, Inc. · MVL · Feb 5, 2013 · DE

Device Facts

• Record ID: K123215
• Device Name: VISCOSTAT CLEAR
• Applicant: Ultradent Products, Inc.
• Product Code: MVL · DE
• Decision Date: Feb 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

ViscoStat Clear is a 25% aluminum chloride gel in a viscous, aqueous vehicle; used in restorative and operative dentistry to manage gingival bleeding/oozing and facilitate sulcus retraction. Applied via plastic syringe with Dento-Infusor tips; used in conjunction with gingival retraction cord. Operated by dental professionals in clinical settings. Gel provides clear, non-staining hemostasis; facilitates cord placement into sulcus. Benefits include improved visibility and tissue management for impression making.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity) and functional testing (aluminum chloride content, effect on shear bond strength, and blood coagulation). No clinical data provided.

Technological Characteristics

25% aluminum chloride gel in aqueous vehicle. Delivered via 1.2mL or 30mL plastic syringes with Dento-Infusor applicator tips. Non-staining, clear formulation. Shelf life of 42 months.

Indications for Use

Indicated for dental patients requiring sulcus retraction prior to impression making and control of bleeding or gingival oozing during restorative and operative dental procedures.

Predicate Devices

• Racegel™ (K093711)

Submission Summary (Full Text)

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## 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

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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<br>aluminum chloride which is<br>intended for sulcus retraction prior<br>to impression taking; control of<br>bleeding and gingival oozing,<br>particularly in restorative dentistry;<br>and, if using a gingival retraction<br>cord, the gel facilitates the insertion<br>of the cord into the sulcus | ViscoStat Clear is intended for sulcus<br>retraction prior to impression<br>making and to control bleeding and<br>gingival oozing in restorative and<br>operative dentistry used with<br>gingival retraction cord and/or the<br>Dento Infusor. The gel facilitates the<br>insertion of the cord into the sulcus. |
| Intended user | Dental professional | Dental professional |
| Chemical<br>Characteristics | Aluminum chloride gel | Aluminum chloride gel |
| Recommended<br>contact time | 2 minutes | 1-3 minutes |
| Delivery system | Pre-filled syringe with applicator tip | 1.2ml pre-filled syringe with<br>applicator tip, 30ml Indispense<br>syringe with 1.2ml empty syringe<br>and applicator tip |
| Physical properties | Orange, odorless gel | Clear gel |

-

**ULTRADENT**
PRODUCTS, INC.

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| | 24 month shelf life | 42 month shelf life |
|--------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Biocompatibility | Acute oral toxicity<br>Sensitization<br>Oral Mucosa Irritation<br>Cytotoxicity | Cytotoxicity |
| Functional Testing | Unknown | Aluminum Chloride content<br>Effect on Shear Bond Strength<br>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.

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### 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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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

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# Section 4: Statement of Indications for Use

510(k) Number (if known): ر

K123215

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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