Astringedent Clear

K152064 · Ultradent Products, Inc. · MVL · Sep 24, 2015 · DE

Device Facts

• Record ID: K152064
• Device Name: Astringedent Clear
• Applicant: Ultradent Products, Inc.
• Product Code: MVL · DE
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Astringedent 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 solution facilitate the insertion of the cord into the sulcus.

Device Story

Astringedent Clear is a 12% aluminum chloride solution used in restorative and operative dentistry. It functions as a hemostatic agent to control bleeding and gingival oozing and facilitates the insertion of gingival retraction cord into the sulcus. The device is applied by dental professionals in a clinical setting. By causing contraction of oral mucosal tissues, it enables clear dental impressions and fluid control. The solution is non-viscous, designed to soak into retraction cord quickly, and leaves no residue or stain, making it suitable for the esthetic zone. It is supplied in 30 mL IndiSpense containers or bottles.

Clinical Evidence

Bench testing only. Testing included aluminum chloride content, wettability, effect on bond strength (shear bond strength), and stability. Results confirmed the device met all design input requirements.

Technological Characteristics

12% w/w aluminum chloride aqueous solution. Non-viscous. Packaged in polypropylene 30 mL Indispense containers or glass bottles. Applied via gingival retraction cord or Dento Infusor. Compatible with dental bonding procedures. No specific software or energy source.

Indications for Use

Indicated for dental professionals to perform sulcus retraction prior to impression making and to control bleeding and gingival oozing during restorative and operative dental procedures.

Predicate Devices

• Viscostat Clear (K123215)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three human profiles incorporated into the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 24, 2015

Ultradent Products, Inc. Corey Jaseph, MS, RAC Regulatory Affairs Manager 505 West 10200 South South Jordan, Utah 84095

Re: K152064

Trade/Device Name: Astringedent Clear Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: August 27, 2015 Received: August 28, 2015

### Dear Ms. Jaseph:

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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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 (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Susan Runner DDS, MA

Erin I. Keith, M.S. 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: Indications For Use Form FDA-3881

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

Device Name Astringedent Clear

Indications for Use (Describe)

Astringedent 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 solution facilitates the insertion of the cord into the sulcus.

Type of Use (Select one or both, as applicable):

| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/4/Picture/0 description: The image shows a logo in brown color. The logo is a stylized design that appears to be a combination of the letters 'U' and 'R'. The 'U' is formed by a thick, rounded line, and the 'R' is created by a similar line that connects to the 'U' at the top right. There is a trademark symbol in the upper right corner of the logo.

# Section 5: Special 510(k) Summary

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### l. Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

| Contact Person: | Ms. Corey Jaseph, MS, RAC |
|-----------------|----------------------------------|
| Title: | Regulatory Affairs Manager |
| Telephone: | 800-552-5512 x4420, 801-553-4420 |
| FAX: | 801-553-4609 |

Date Summary Prepared:

#### II. Name of the Device

| Trade Name: | Astringedent Clear |
|------------------------------|----------------------|
| Common Name: | Retraction Cord |
| Device Classification: | Unclassified |
| Classification Product Code: | MVL |
| Regulation No. | None (pre-amendment) |

#### lll. Predicate Device:

Astringedent Clear is substantially equivalent to Viscostat Clear (K123215), also manufactured by Ultradent Products, Inc.

23 July 2015

#### IV. Device Description:

Astringedent Clear is a 12% w/w aluminum chloride solution in a non-viscous, aqueous vehicle. It leaves no residue or stain, making it ideal for use in the esthetic zone. It is packaged in two configurations: 30 mL IndiSpense, 30 mL bottle packaged with retraction cord. It is used both for obtaining clear dental impressions, as well as operative dental procedures requiring hemostasis and fluid control.

Image /page/4/Picture/13 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" and "P" interlocked, followed by the text "ULTRADENT" in a bold, sans-serif font. Below "ULTRADENT" is the text "PRODUCTS, INC." in a smaller font size. The logo is displayed on a white rectangular background with rounded corners, and the colors used are a shade of brown.

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#### V. Statement of intended use:

Astringedent 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 solution facilitate the insertion of the cord into the sulcus.

#### VI. Comparison of technological characteristics

Astringedent Clear and Viscostat Clear have similar technological characteristics:

| Characteristic | Predicate: Viscostat Clear<br>(K123215) | Astringedent Clear |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Viscostat Clear is intended for sulcus<br>retraction prior to impression making<br>and to control bleeding and gingival<br>oozing in restorative and operative<br>dentistry used with gingival retraction<br>cord and/or the Dento Infusor. The<br>gel facilitates the insertion of the cord<br>into the sulcus. | Astringedent Clear is intended for sulcus<br>retraction prior to impression making and to<br>control bleeding and gingival oozing in<br>restorative and operative dentistry used with<br>gingival retraction cord and/or the Dento<br>Infusor. The solution facilitates the insertion of<br>the cord into the sulcus. |
| Intended user | Dental professional | Dental professional |
| Chemical<br>Characteristics | Aluminum chloride gel | Aluminum chloride solution |
| Primary Container | 30 ml Indispense container, 1.2 mL<br>syringe | 30 ml Indispense container, 30 ml bottle<br>packaged with retraction cord |
| Physical properties | Clear gel | Clear solution |
| Compatibility | Does not adversely affect bond<br>strength when used as directed | Does not adversely affect bond strength when<br>used as directed |
| Time in mouth | 1 - 3 minutes | 1 – 3 minutes |
| Viscosity | Viscous gel | Nonviscous solution |
| Biocompatibility | Device demonstrated to have low<br>cytotoxicity per ISO 10993-5, ISO<br>7405 | Device not tested (same active ingredient,<br>similar formulation) |

## Table 5-1: Substantial equivalence comparison

Astringdent Clear has been tested for aluminum chloride content, wettability, effect on bonding (shear bond strength), and stability, and met all design input requirements. Astringedent Clear has the same indications for use, intended user, active ingredient,

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same/similar delivery systems (predicate and modification are delivered in a polypropylene 30 mL Indispense syringe, and the modification is also available in a 30 mL glass bottle packaged with retraction cord), and use time. Astringedent Clear is less viscous than Viscostat Clear, which is intended to allow it to more easily and quickly soak into retraction cord for routine use in ensuring and maintaining hemostasis and sulcular fluid control during retraction.

Both work by using aluminum chloride to cause a contraction of the oral mucosal tissues, resulting in control of routine bleeding and sulcular fluid. Aluminum chloride has been used for many years in this manner for obtaining clear dental impressions and operative dental procedures requiring hemostasis and fluid control, as described in peer-reviewed literature.

Based on the results of design verification testing as outlined above, Ultradent has determined that Astringedent Clear is substantially equivalent to Viscostat Clear.