A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.

Device Description

A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.

AI/ML Overview

Here's an analysis of the provided information regarding the A-SILICONE device, focusing on acceptance criteria and the study proving it:

The provided document is a 510(k) summary for a dental impression material named A-SILICONE. A 510(k) submission primarily demonstrates substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving acceptance against a set of performance criteria through a traditional clinical study with defined ground truth and expert adjudication in the same way a diagnostic AI might be evaluated.

Therefore, the answers below will reflect this context, explaining that the "acceptance criteria" here are essentially the properties and performance parameters that need to be comparable to predicate devices for a favorable substantial equivalence determination. The "study" for this type of device is the testing conducted to measure these properties against established standards or predicate device performance.

Acceptance Criteria and Study for A-SILICONE

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a dental impression material, the "acceptance criteria" are the physical and chemical properties that demonstrate it is as safe and effective as predicate devices. The reported device performance is measured against these properties.

Property	Acceptance Criteria (Implied by Predicate & ISO Standards)	Reported Device Performance (A-SILICONE)
Consistency, ISO 4823	Type-specific (e.g., heavy body type 0, light body type 3)	Matches ISO 4823 types for each viscosity
Color	Distinct colors for different viscosities	Putty: light green, Heavy: turquoise, Medium: lilac, Light: pink
Working time including mixing	Clinically acceptable range	45 seconds to one minute
Time in the mouth	Clinically acceptable range	two minutes
Total setting time, minimum	Clinically acceptable range	2 minutes - 45 seconds
Strain in compression, %	Typically low (< 5-6%) for impression materials	Putty: <2, Heavy: <4, Medium: <5, Light: <5
Recovery from deformation, %	High (>99%) to ensure impression accuracy	Putty: >99.4, Heavy: >99.4, Medium: >99.6, Light: >99.6
Linear dimensional change, %, max	Low (<0.2%) for dimensional stability	Putty: 0.2, Heavy: 0.15, Medium: 0.15, Light: 0.15
Hardness Shore A	Appropriate range for impression material type	Putty: 70, Heavy: 50, Medium: 45, Light: 40
Intended Use	Reproduction of teeth/gums, bite registration	Matches predicate devices
Composition	Addition reaction, silica filled polydimethyl siloxane	Matches predicate devices
Clinical properties	Multiple viscosities allowing various techniques	Matches predicate devices
Viscosities or grades available	Putty, heavy, medium, light body	Matches predicate devices

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

The document does not specify a "test set" in the context of patient data or a clinical trial. For material properties, testing is typically done on a sufficient number of material samples (batches or specimens) to ensure statistical validity and reproducibility of the measurements. This is in vitro testing, not in vivo (patient) testing.

Sample Size: Not explicitly stated, but for physical/chemical property testing of materials, this would typically be multiple samples per batch, and multiple batches to demonstrate consistency.
Data Provenance: The data would be derived from laboratory testing of the A-SILICONE material itself, likely performed by the manufacturer (Cosmedent, Inc.) or a contract testing lab. It is in vitro (laboratory) data.

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

This type of information (experts establishing ground truth for a test set) is not applicable to a 510(k) submission for a dental impression material demonstrating substantial equivalence through physical property testing. "Ground truth" in this context refers to the measured physical and chemical properties of the material itself, determined by standardized laboratory methods (e.g., ISO 4823 for consistency). These are objective measurements, not subjective evaluations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert opinion for material property testing. Measurements are objective and follow standard protocols.

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/diagnostic device. It is a dental impression material. MRMC studies are used for evaluating diagnostic performance, often with AI assistance, which is irrelevant for this product.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on standardized physical and chemical property measurements (e.g., consistency by ISO 4823, strain in compression, recovery from deformation, linear dimensional change, hardness) as well as a demonstration that its intended use and composition are comparable to legally marketed predicate devices. This is a form of empirical measurement against established material science standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical material, 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" for a physical material, there is no ground truth to establish for one. The "ground truth" for material properties is established through standardized laboratory testing and measurement protocols.

Summary

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Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for A-Silicone Page 12 of 15

JUN 1 7 2004

510(k) SUMMARY

As required by the Safe Medical Devices Act of 1990

A-SILICONE

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES

Bisco TWINZ VPS Heraeus Kulzer FLEXITIME

The two indicated predicate devices are addition reaction silicone impression materials also known as vinyl polysiloxane impression materials. The viscosity range is similar to A-SILICONE in that they contain examples of putty based, heavy body, medium body and light body products intended for identical uses in dentistry, that is, for taking impressions of teeth, prepared teeth, oral soft tissue, and bite registrations.

	CosmedentA-SILICONE	Heraeus KulzerFLEXITIME1-2	BiscoTWINZ VPS3-4
Intended Use	Auto-mix,elastomeric dentalimpressionmaterial	Auto-mix,elastomeric dentalimpressionmaterial	Auto-mix,elastomeric dentalimpressionmaterial
Composition	Addition reaction,silica filledpolydimethylsiloxane	Addition reaction,silica filledpolydimethylsiloxane	Addition reaction,silica filledpolydimethylsiloxane
Clinical properties	Multipleviscositiespermitting dual-mix, monophase,and putty-washtechniques	Multipleviscositiespermitting dual-mix, monophase,and putty-washtechniques	Multipleviscositiespermitting dual-mix, monophase,and putty-washtechniques
Viscosities or gradesavailable	Putty, heavy body,medium body, andlight body	Putty, Heavybody, mediumbody, andcorrective lightbody	Putty, heavybody, mediumbody, light body,and extra lightbody

SUBSTANTIAL EQUIVALENCE Summary

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A-SILICONE 510(k) SUMMARY (cont)

DESCRIPTION OF THE APPLICANT DEVICE - A-SILICONE

PROPERTY	Putty	Heavy Body	MediumBody	LightBody
Consistency, ISO 4823	heavy bodytype 0	heavy bodytype 1	Medium bodytype 2	Light bodytype 3
Color	light green	turquoise	lilac	pink
Working time includingmixing	45 seconds to one minute
Time in the mouth	two minutes
Total setting time,minimum	2 minutes - 45 seconds
Strain in compression, %	<2	<4	<5	<5
Recovery fromdeformation, %	>99.4	>99.4	>99.6	>99.6
Linear dimensional change,%, max	0.2	0.15	0.15	0.15
Hardness Shore A	70	50	45	40

MATERIALS SPECIFICATIONS

INTENDED USES OF THE APPLICANT DEVICE

A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.

Jami K. Sanchez

James L. Sandrik, Ph.D.

Cosmedent, Inc. Suite 2500 401 N. Michigan Ave. Chicago, Illinois 60611

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized lines representing the wings or body.

JUN 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Dr. James L. Sandrik Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

Re: K041229

Trade/Device Name: Multiple (A-Silicone) Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 7, 2004 Received: May 10, 2004

Dear Dr. Sandrik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becareermined the device is substantially equivalent (for the icitications for use stated in the enclosure) to legally marketed predicate devices marketed in multions for asso states in May 28, 1976, the enactment date of the Medical Device Interstate commerce prior st hat have been reclassified in accordance with the provisions of Amendinents, or to ac nove aller metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rist stion, 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 If your device is classinod (oos aboutional controls. Existing major regulations affecting (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.

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Page 2 -Dr. Sandrik

Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 12 a determination that your device complies with other requirements modi that I Dri may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal states requirements, including, but not limited to: registration r ou must comply Will and 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF rear 807), and iity systems (QS) regulation (21 CFR Part 820); and if requirements us set form in artistion 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) This letter will and w yourse obger finding of substantial equivalence of your device to a premarket notification. - The Pore 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), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 5 of 15

INDICATIONS FOR USE

510(k) Number (if known): KO41229

Device Name: MULTIPLE (A-SILICONE)

Indication For Use:

A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number: KO41083

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).