Aquasil® Ultra+ Smart Wetting® Impression Material is a quadrafunctional hydrophilic addition reaction silicone elastomeric dental impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.

AI/ML Overview

This document describes the Aquasil® Ultra+ Smart Wetting® Impression Material, a dental impression material. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification to the surfactant used in the material.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Internal DENTSPLY Procedure Requirements/ISO Standards)	Reported Device Performance (Aquasil® Ultra+ Smart Wetting® Impression Material)
Wettability (Contact Angle)	Meets Internal DENTSPLY procedure requirements
Mechanical (Compressive Strength, Tear Strength)	Meets Internal DENTSPLY procedure requirements
Uncured Base Paste – Cytotoxicity Study Using the ISO Elution Method	Meets ISO Elution Method requirements
Uncured Catalyst Paste – Cytotoxicity Study Using the ISO Elution Method	Meets ISO Elution Method requirements
Cured Base/Catalyst – Cytotoxicity Study Using the ISO Agarose Overlay Method	Meets ISO Agarose Overlay Method requirements
ISO Oral Mucosal Irritation Study in Hamsters – Collar Method - 24 Hrs.	Meets ISO Oral Mucosal Irritation requirements
ISO Guinea Pig Maximization Sensitization Test	Meets ISO Guinea Pig Maximization Sensitization Test requirements
OECD 425 Acute Oral Toxicity Study in Rats, Limit Test	Meets OECD 425 Acute Oral Toxicity requirements
ISO 4823 Dentistry - Elastomeric Impression Materials	Meets the requirements of ISO 4823

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests and biocompatibility tests. The document states:

"The performance of the Aquasil® Ultra + Smart Wetting® Impression Material satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence."
"The results of the biocompatibility testing of Aquasil® Ultra + Smart Wetting® Impression Material are equivalent to the predicate device Aquasil® Ultra Smart Wetting® Impression Material 510(k) cleared under K113406."
"The test results of Aquasil Ultra + Smart Wetting® Impression Material LV Base and Catalyst paste, met the requirements of the three recommended biocompatibility tests; as per ISO10993-1:2009; Cytotoxicity, Sensitization (Delayed-type hypersensitivity), and Irritation or intracutaneous reactivity."
"Other tests, including Contact Angle and Tear Strength were performed and the results of these activities... support substantial equivalence."

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

Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "All required verification and validation activities, as identified through risk analysis were performed."
Data Provenance: The data provenance is primarily from bench testing and biocompatibility studies conducted by DENTSPLY International, Inc. This would typically be prospective testing performed in a controlled laboratory environment to evaluate the modified device. There is no mention of country of origin for the data beyond DENTSPLY's location in York, PA, USA.

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

This information is not provided in the document. The testing described is primarily physical property measurement and biocompatibility studies, which do not typically involve human expert interpretation of results to establish ground truth in the way medical imaging algorithms do. The "ground truth" here is objective measurement against established ISO standards and internal procedure requirements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for human-interpreted data, especially in clinical trials or image-based diagnostic studies. Since this submission is for a dental impression material and focuses on non-clinical performance and biocompatibility, an adjudication method for a test set is not applicable and therefore not described.

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

No MRMC comparative effectiveness study was done. This is a submission for a dental impression material, not an AI-powered diagnostic device, so this type of study is not applicable.

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

This is not an AI-powered device. Therefore, a standalone algorithm performance evaluation is not applicable. The tests are performed on the material itself.

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

The "ground truth" for the non-clinical performance tests and biocompatibility studies is based on established international standards (ISO, OECD) and internal DENTSPLY procedure requirements. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set

This is not an AI/machine learning device that requires a training set. Therefore, sample size for a training set is not applicable.

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

As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for a training set.

Summary

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

March 4, 2016

DENTSPLY International, Inc. Ms. Helen Lewis Director, Corporate Regulatory Affairs Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Re: K152861

Trade/Device Name: Aquasil® Ultra+ Smart Wetting® Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: February 3, 2016 Received: February, 04, 2106

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 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 801and Part 809); 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 and Part 809), 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Tina Kiang

for 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 STATEMENT

K152861 510(k) Number (if known):

Device Name: Aquasil® Ultra + Smart Wetting® 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)

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Image /page/3/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letter "P" has a unique design, with the vertical line extending below the baseline and the curved part of the "P" intersecting with the "L".

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street PO Box 872 York, PA 17405-0872 (717) 849-4593 Fax (717) 849-4343

SECTION 5. 510(k) SUMMARY

for Aquasil® Ultra + Smart Wetting® Impression Material

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

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: 28 September 2015

2. Device Name:

• Proprietary Name:	Aquasil® Ultra + Smart Wetting® Impression Material
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Classification Name: Impression Material ●
. CFR Number: 872.3660
Device Class: . II
Product Code: ELW ●

3. Sponsor's Predicate Device:

510(k) cleared under K113406 Aquasil® Ultra Smart Wetting® Impression Material ●

4. Description of Device:

5. Indications for Use:

Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques.

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6. Substantial Equivalence:

Technological Characteristics.

The Aquasil® Ultra + Smart Wetting® Impression Material represents a modification to the 510(k) cleared under K113406. The modification to the Aquasil® Ultra Smart Wetting Impression Material XLV (Extra Low Viscosity) is removal of the current surfactant and replaced with a mixture of two other surfactants in the base paste. The modification to the Aquasil® Ultra Smart Wetting® Impression Material LV (Low Viscosity) is removal of the current surfactant and replaced with a mixture of two other surfactants in the base paste. This change allows for a faster wetting of water on the surface of the impression material.

Similarities and Differences between the proposed and the predicate devices
Proposed Device	Predicate Device
Aquasil® Ultra +Smart Wetting® Impression Material	Aquasil® UltraSmart Wetting® Impression MaterialK113406
Indications for Use: Aquasil® Ultra + SmartWetting® Impression Material is indicatedfor all dental impression techniques.Surfactant-Fluoroaliphatic oxyethyleneadduct	Indications for Use: Aquasil® Ultra SmartWetting® Impression Material is indicatedfor all dental impression techniques.Surfactant-Polyoxyethylene modifiedpolydimethylsiloxane
Contains:silicone polymers and cross linkerorganoplatinum complex catalystretarderplatinum calcium carbonatedegassing concentratewetting agentpeppermint oilfillerspigments	Contains:silicone polymers and cross linkerorganoplatinum complex catalystretarderplatinum calcium carbonatedegassing concentratewetting agentpeppermint oilfillerspigments
Can be self-cured after mixing two separateparts	Can be self-cured after mixing two separateparts
Two parts are separated and mixed prior touse	Two parts are separated and mixed prior touse
Paste/paste systems in dual-barrel syringesand delivered through auto-mix tip	Paste/paste systems in dual-barrel syringesand delivered through auto-mix tip
High tear strength	High tear strength
Can be dispensed from cartridgedispensing gun	Can be dispensed from cartridgedispensing gun

nd Difforoncos battygan the proposad and the prodicato dovices

7. Non-Clinical Performance Data

The performance of the Aquasil® Ultra + Smart Wetting® Impression Material satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence. The results of the biocompatibility testing of Aquasil® Ultra + Smart Wetting® Impression Material are equivalent to the predicate device Aquasil® Ultra Smart Wetting® Impression Material 510(k) cleared under K113406.

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The table below displays the necessitated biocompatibility and performance testing from the change in the surfactant.

Physical Property	Results
Wettability (Contact Angle)	Meets Internal DENTSPLY procedure requirements
Mechanical (Compressive Strength, Tear Strength)	Meets Internal DENTSPLY procedure requirements
Uncured Base Paste –Cytotoxicity Study Using the ISOElution Method – (Test articleincubated for 10 minutes.)	Meets ISO ElutionMethod requirements
Uncured Catalyst Paste –Cytotoxicity Study Using the ISOElution Method	Meets ISO Elution Methodrequirements
Cured Base/Catalyst – CytotoxicityStudy Using the ISO AgaroseOverlay Method	Meets ISO Agarose OverlayMethod requirements
ISO Oral Mucosal Irritation Studyin Hamsters –Collar Method - 24 Hrs.	Meets ISO Oral MucosalIrritation requirements
ISO Guinea Pig MaximizationSensitization Test	Meets ISO Guinea PigMaximization SensitizationTest requirements
OECD 425 Acute Oral ToxicityStudy in Rats, Limit Test	Meets OECD 425 Acute OralToxicity requirements

Biocompatibility Conclusion:

The test results of Aquasil Ultra + Smart Wetting® Impression Material LV Base and Catalyst paste, met the requirements of the three recommended biocompatibility tests; as per ISO10993-1:2009; Cytotoxicity, Sensitization (Delayed-type hypersensitivity), and Irritation or intracutaneous reactivity. These results were equivalent to the results from the same tests of Aquasil® Ultra Smart Wetting® Impression Material included in 510(k) cleared under K113406.

Risk Analysis Activities:

A Risk Management system is employed as part of the Design Control process. This includes, but is not limited to, the development of a Design Failure Modes and Effects Analysis (dFMEA) to evaluate any risks associated with the design of the product. Additionally, a Process FMEA (pFMEA) is developed to specifically address the manufacturing process. The individual risks are evaluated and mitigated, as needed. This may include additional Verification and Validation activities in order to demonstrate that the Design Outputs meet the Design Input requirements. At the conclusion of all Risk Management activities, residual risk for the product is determined.

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Design Control Procedures:

The Design Control procedures that are used at DENTSPLY comply with all requirements outlined in 21 CFR §820.30. These procedures represent an effective Design Control process that addresses Design and Development Planning, Design Inputs, Outputs, Reviews, Verification, Validation, Transfer, and Changes. All of the documents that are generated over the course of the development effort result in the assembly of the Design History File.

Verification & Validation Activities:

All required verification and validation activities, as identified through risk analysis were performed by designated individuals and the results indicate that the design meets all predetermined acceptance criteria. Furthermore, the manufacturing facility is in conformance with the design control procedures requirements outlined in 21 CFR §820.30. The records addressing this compliance are available for review.

8. Conclusion Regarding Substantial Equivalence

The Aquasil® Ultra + Smart Wetting® Impression Material is an Elastomeric Impression Material which is intended to reproduce the hard and soft tissue in the mouth. The Aquasil® Ultra + Smart Wetting® Impression Material has the same intended use, incorporates the same fundamental technology, and has the same indications for use as the predicate Aquasil® Ultra Smart Wetting® Impression Material cleared under premarket notification K113406.

Design control activities have been conducted to verify that the Aquasil® Ultra + Smart Wetting® Impression Material meets the design requirements and intended use. The Aquasil® Ultra + Smart Wetting Impression Material meets the requirements of ISO 4823 Dentistry -Elastomeric Impression Materials. Other tests, including Contact Angle and Tear Strength were performed and the results of these activities, combined with the design and intended use comparison with the predicate device, support substantial equivalence.

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).