Used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a heavy viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Device Description

In a two-part catalyst/base hydrophilic vinylpolysiloxane impression material. It is formulated for regular set and fast set. This impression material is a heavy viscosity and is available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery.

AI/ML Overview

This 510(k) summary describes a modification to an existing dental impression material, Aquasil Rigid™ Smart Wetting Impression Material (K970433), rather than a new AI/ML device. Therefore, the detailed information requested regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable or available in the provided text.

The submission focuses on demonstrating substantial equivalence to the predicate device based on material composition and biocompatibility, not on a performance study of AI/ML capabilities.

Here's an attempt to fill only the relevant (and very limited) information based on the provided text, acknowledging that most questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility (Cytotoxicity for uncured material)	Passed
Biocompatibility (Cytotoxicity for cured material)	Passed
Biocompatibility (Mutagenicity for cured material)	Passed
Biocompatibility (Irritation for cured material)	Passed
Biocompatibility (Sensitization for cured material)	Passed

2. Sample size used for the test set and the data provenance:

Not Applicable. The submission describes biocompatibility testing for a dental impression material, not a study involving a "test set" in the context of AI/ML or a clinical performance study with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. The concept of "ground truth" established by experts is not relevant to the type of biocompatibility testing described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are not relevant to biocompatibility testing.

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 is not an AI-assisted device.

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

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable. For biocompatibility, the "ground truth" would be the observed biological response according to standardized in vitro or in vivo tests, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:

Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment process.

Summary based on the provided text:

The submission for AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL (K021413) is a 510(k) premarket notification for a modification to an existing dental impression material. The focus is on demonstrating substantial equivalence to a predicate device (Aquasil Rigid™ Smart Wetting Impression Material, K970433).

The primary "study" mentioned for the modified device is biocompatibility testing. This testing evaluated:

Uncured material: Cytotoxicity
Cured material: Cytotoxicity, mutagenicity, irritation, and sensitization

The device passed all these biocompatibility tests. This is the extent of the "device performance" described in the provided document. The basis for safety and effectiveness is that the components have been used in legally marketed devices or found safe for use, and the modified device passed biocompatibility testing, supporting its substantial equivalence to the predicate.

Summary

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

510(k) SUMMARY _______________________________________________________________________________________________________________________________________________________________

DENTSPLY

NAME & ADDRESS: Ko21413

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax 1777 849-4762

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

May 2, 2002 DATE PREPARED:

PROPRIETARY NAME: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL

Impression Material (872.3660) CLASSIFICATION NAME:

PREDICATE DEVICES: Aquasil Rigid™ Smart Wetting Impression Material K970433

DEVICE DESCRIPTION: DE TOD BESONE In a two-part catalyst/base hydrophilic vinylpolysiloxane impression material. It is formulated for regular set and fast set. This impression material is a heavy viscosity and is available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery.

INTENDED USE: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a heavy viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

TECHNOLOGICAL CHARACTERISTICS: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL represents a modification to Aquasil Rigid Smart Wetting Impression Material (K970433).

All of the components have been used in legally marketed devices or were found safe for use. Uncured AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicty. Cured AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL was evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, irritation, and sensitization.

We believe that the data provided regarding the modifications to the predicate device support the safety and effectiveness of AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL for the indicated uses.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

MAY 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405

Re: K021413

Trade/Device Name: Aquasil Ultra Rigid Smart Wetting Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 02, 2002 Received: May 03, 2002

Dear Mr. Lehn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

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

Page 2 - Mr. P. Jeffery Lehn

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runper

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e) -

KO21413 510(K) Number (if known):

Device Name: AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL

Indications for Use:

These are the same Indications for Use as previously cleared for the Aquasil Rigid™ Smart Wetting Impression Material (K970433).

Mssy Browne for msR
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

MODIFICATION TO K970433

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).