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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Astringedent Clear." It outlines a comparison between the new device and a predicate device (Viscostat Clear). However, it does not contain a study or detailed data proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is a different regulatory pathway. The "acceptance criteria" here are aligned with showing that the new device is as safe and effective as the predicate device, despite some minor differences.

Here's an attempt to extract and frame the information you requested, based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit "acceptance criteria" in a quantitative sense (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating similar technological characteristics and performance to the predicate device.

Characteristic	Acceptance Criteria (Implied by Predicate - Viscostat Clear)	Reported Device Performance (Astringedent Clear)
Intended Use	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 Dento Infusor; facilitates cord insertion.	Identical: 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 Dento Infusor; facilitates cord insertion.
Intended User	Dental professional	Dental professional
Chemical Characteristics	Active ingredient: Aluminum chloride gel	Active ingredient: Aluminum chloride solution (12% w/w)
Primary Container	30 ml Indispense container, 1.2 mL syringe	30 ml Indispense container, 30 ml bottle packaged with retraction cord
Physical Properties	Clear gel	Clear solution
Compatibility	Does not adversely affect bond strength when used as directed.	Does not adversely affect bond strength when used as directed. (Tested as "effect on bonding (shear bond strength)")
Time in Mouth	1 - 3 minutes	1 - 3 minutes
Viscosity	Viscous gel	Nonviscous solution (This is a distinguishing characteristic, claimed to allow easier/quicker soaking into cord)
Biocompatibility	Low cytotoxicity per ISO 10993-5, ISO 7405	Not tested, but acceptable because it uses the "same active ingredient, similar formulation" as the predicate which was tested.
Other Performance	(Implied safe and effective for its purpose)	"Astringedent Clear has been tested for aluminum chloride content, wettability, effect on bonding (shear bond strength), and stability, and met all design input requirements." (Specific criteria/results not provided, but stated to have been met.) Validation that it functions as a hemostatic/retraction agent.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical data for performance evaluation (e.g., a set of patient cases). The evaluation performed was "design verification testing" on the device itself.

Sample Size: Not specified for the "design verification testing" (aluminum chloride content, wettability, shear bond strength, stability).
Data Provenance: This is a submission to the FDA for a medical device. The data would be generated through in-house laboratory testing and potentially animal studies (though not explicitly mentioned for this product beyond biocompatibility standards). No information is provided regarding country of origin for any human data (as there appears to be none presented). The testing is prospective for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study assessing diagnostic accuracy or expert interpretation. Therefore, there is no "ground truth" established by experts in the context of a test set of cases.

4. Adjudication Method for the Test Set

Not applicable. There is no expert review or adjudication process described for clinical cases or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a dental solution (astringent) and not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical chemical solution, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

For the "design verification testing," the "ground truth" would be established by:

Chemical standards/specifications: for aluminum chloride content.
Physical property measurements: for wettability and stability.
Laboratory-based testing standards: for shear bond strength (measuring adhesion of restorative materials to tooth structure after treatment with the solution).
Biocompatibility standards (ISO 10993-5, ISO 7405): for cytotoxicity of the predicate device (and by extension, the new device due to similar formulation).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary of the Study:

The "study" referenced in the document is a design verification testing and substantial equivalence demonstration comparing "Astringedent Clear" to its predicate "Viscostat Clear." The manufacturer, Ultradent Products, Inc., performed in-house testing to confirm that Astringedent Clear met "all design input requirements" and was comparable to the predicate device regarding its intended use, mechanism of action, and safety characteristics. Key findings supporting equivalence included:

Identical intended use, intended user, and active ingredient (aluminum chloride).
Similar delivery systems.
Similar "time in mouth" (1-3 minutes).
Testing for aluminum chloride content, wettability, effect on bonding (shear bond strength), and stability confirmed it met design requirements.
Biocompatibility was deemed acceptable based on the predicate device's testing and the new device's similar formulation and active ingredient.

The primary difference noted was the new device's non-viscous solution consistency compared to the predicate's viscous gel, a change intended to improve ease of use (easier and quicker soaking into retraction cord). The regulatory pathway for this device is a 510(k) premarket notification, which relies on demonstrating substantial equivalence rather than independent proof of safety and effectiveness through extensive clinical trials for new device types.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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(K123215)	Astringedent Clear
Intended Use	Viscostat Clear is intended for sulcusretraction prior to impression makingand to control bleeding and gingivaloozing in restorative and operativedentistry used with gingival retractioncord and/or the Dento Infusor. Thegel facilitates the insertion of the cordinto the sulcus.	Astringedent Clear is intended for sulcusretraction prior to impression making and tocontrol bleeding and gingival oozing inrestorative and operative dentistry used withgingival retraction cord and/or the DentoInfusor. The solution facilitates the insertion ofthe cord into the sulcus.
Intended user	Dental professional	Dental professional
ChemicalCharacteristics	Aluminum chloride gel	Aluminum chloride solution
Primary Container	30 ml Indispense container, 1.2 mLsyringe	30 ml Indispense container, 30 ml bottlepackaged with retraction cord
Physical properties	Clear gel	Clear solution
Compatibility	Does not adversely affect bondstrength when used as directed	Does not adversely affect bond strength whenused as directed
Time in mouth	1 - 3 minutes	1 – 3 minutes
Viscosity	Viscous gel	Nonviscous solution
Biocompatibility	Device demonstrated to have lowcytotoxicity per ISO 10993-5, ISO7405	Device not tested (same active ingredient,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.

Regulation Number and Section

N/A