AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is a two-part catalyst/base hydrophilic viny!polysiloxane elastomeric impression material suitable for all dental impression techniques where a light body (wash) and/or medium/heavy body (tray) material would be desired by the operator. Aquasil Ultra Smart Wetting Impression Material is available in light-bodied, medium-bodied or heavy-bodied consistencies; and fast set. regular set or extended work time.

AI/ML Overview

This document describes a 510(k) premarket notification for AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL. This submission is for modifications to already cleared products, not for a new device requiring a full de novo clearance or extensive new clinical data. Therefore, the information provided focuses on the substantial equivalence to existing devices rather than new performance data against specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The submission explicitly states: "There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials."

Therefore, explicit new acceptance criteria and new reported performance are not provided in this document. The device relies on the performance data established for its predicate devices.

Acceptance Criteria Category	Original Performance (from Predicate Devices)
Toxicological Safety	Components previously cleared and used in predicate devices; no changes to material composition. Implies existing toxicological safety is maintained.
Physical Characteristics	No changes affecting fundamental technology or chemical composition. Minor quantitative changes to existing ingredients do not affect physical characteristics and mechanical properties. Implies existing physical characteristics (e.g., set time, consistency, hydrophilicity, tear strength, dimensional stability relevant to impressions) are maintained.
Mechanical Properties	No changes affecting fundamental technology or chemical composition. Minor quantitative changes to existing ingredients do not affect physical characteristics and mechanical properties. Implies existing mechanical properties (e.g., hardness, elasticity, detail reproduction) are maintained.
Indications for Use	Original broad indications for "all dental impression techniques" maintained, with some consolidation/clarification in this submission.

2. Sample Size for the Test Set and Data Provenance

No new test set data is provided or referenced, as the submission focuses on documenting minor changes to an already cleared device and asserting substantial equivalence based on the lack of impact on fundamental technological characteristics, physical properties, or mechanical properties. Therefore, this information is not applicable to this submission.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted or referenced.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication was conducted or referenced.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This submission does not involve a multi-reader multi-case comparative effectiveness study. The device is a dental impression material, not an imaging or diagnostic device typically subject to MRMC studies.

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

Not applicable. This is a physical dental impression material, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. As no new performance testing showing specific new results against a ground truth was conducted for this 510(k) to demonstrate new performance, this information is not relevant. The substantial equivalence relies on the unchanged fundamental characteristics and previously established performance of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a manufactured dental material; there is no "training set" in the context of an algorithm or AI.

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

Not applicable. There is no training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is not a new clinical or performance study. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" in this context refers to the analysis and documentation provided by the manufacturer (DENTSPLY International) to the FDA, asserting that:

Technological Characteristics: No changes affect the fundamental technological characteristics of the device.
Material Composition: The components have all been used in the predicate devices. While there are "minor quantitative changes to the existing ingredients," these changes "do not affect the physical characteristics and mechanical properties of the materials."
Non-Clinical Performance Data (Toxicological Testing): All components have been previously used in cleared devices, and there are no changes to the material composition from a toxicological perspective. This implies that the toxicological profile remains consistent with the already cleared devices.
Physical Properties & Mechanical Properties: The minor quantitative changes do not affect these properties. Therefore, the device is presumed to perform identically to its predicates in terms of physical and mechanical behavior relevant to dental impressions.
Clinical Performance Data: Stated as "Not applicable," further reinforcing that no new clinical studies were conducted for this specific 510(k) submission.

In essence, the "proof" is the argument of no significant change from the predicate devices that would alter safety or effectiveness, thus maintaining the established acceptance criteria of those predicates. The FDA concurred with this assessment, issuing a substantial equivalence determination.

Summary

{0}------------------------------------------------

K113406

Suite 60W

DENTSPLY International World Headquarters

York, PA 17405-0872 18001 877-0020

Fax (717) 849-4343 www.dentsply.com

Susquehanna Commerce Center 221 West Philadelphia Street

SECTION 5. 510(k) SUMMARY for Title of Submission

Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

November 11, 2011 Date Prepared:

2. Device Name:

Proprietary Name: .
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL

Material, Impression 872.3660

CFR Number: Device Class:
Classification Name:
[] . ELW Product Code: .

Predicate Device: 3.

DENTSPLY International's:

. K021410- Aquasil Ultra XLV Smart Wetting Impression Material .
K021413- Aquasil Ultra Rigid Smart Wetting Impression Material .
K021416- Aquasil Ultra Monophase, Heavy and LV Smart Wetting Impression . Material .

4. Description of Device:

న్. Indications for Use:
Aquasil Ultra Smart Wetting Impression Material is indicated for all dental impression techniques.

{1}------------------------------------------------

Description of Safety and Substantial Equivalence: 6.

Technological Characteristics

There are no changes proposed in this premarket notification which affect the fundamental technological characteristics of the subject devices. The intent of this premarket notification is: 1). The addition of the contraindication. "Aquasil Ultra Impression Material is contraindicated for use with patients who have a history of severe allergic reaction to peppermint oil or any of the components": 2). Clarification of warnings and precautions through the addition of warning against the use of the devices as a temporary reliner as well as a precaution their use with polvether. polysulfide, or condensation silicone materials; 3). Consolidation of Indications for Use; and 4). Documentation of minor quantitative changes to the existing ingredients in the composition of the AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL. AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL, and AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL cleared in premarket notifications K021410, K021413, and K021416, respectively. The changes described do not affect the substantial equivalence of the devices as originally cleared in premarket notifications K021410, K021413, and K021416.

Non-Clinical Performance Data.

Toxicological Testing

All of the components used in the subject impression materials have been used in the devices as cleared in premarket notifications K021413, and K021416. There are no changes to the material composition of the subject impression materials proposed in this premarket notification.

Physical Properties

The purpose of this premarket notification is the addition of a contraindication; clarification of warnings and precautions; and clarification of the Indications for Use of the existing AOUASIL ULTRA SMART WETTING MATERIALS previously cleared in premarket notifications K021410, K021413, and K021416. There are no changes affecting the fundamental technology and chemical composition of the subject materials. There are minor quantitative changes to the existing ingredients in the material composition, but these changes do not affect the physical characteristics and mechanical properties of the materials.

Clinical Performance Data. Not applicable.

Conclusion as to Substantial Equivalence

AQUASIL ULTRA XLV, LV, MONOPHASE, HEAVY, RIGID, XTRA WASH and XTRA TRAY SMART WETTING IMPRESSION MATERIAL are substantially equivalent to the currently marketed predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

FEB 1 3 2012

Re: K113406

Trade/Device Names: Aquasil Ultra Smart Wetting Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 11, 2011 Received: November 18, 2011

Dear Ms. Lewis:

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 approval approvisions 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 If your device is chasilited (so itional 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.

{3}------------------------------------------------

Page 2 - Ms. Lewis

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 (reporting of inements 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 1 ou may 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 vours.

Wh for

Anthony D. 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

{4}------------------------------------------------

SECTION 4. INDICATIONS FOR USE STATEMENT

113406

510(k) Number (if known):

Device Name: AQUASIL ULTRA SMART WETTNG IMPRESSION MATERIAL

Indications for Use:

AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL is indicated for all dental impression techniques.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swen Rumpis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

113406

Image /page/4/Picture/15 description: The image shows a sequence of numbers. The numbers are 000009. The first five digits are zeros, and the last digit is a nine.

DENTSPLY International

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).