Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials are addition-curing, elastomeric preliminary impression materials, to be used as an alternative to traditional alginate materials.

Kettosil, Silginat and Silginat Strawberry are suitable for impressions in preparation of:

Preliminary impression
Anatomical models
Fabricating temporary crowns and bridges
Opposing dentition
Fabricating simple removable prosthetic restorations
Orthodontic work
Fabricating removable retainers and splints
Case study models
Producing models for the construction of trays for whitening solutions, bites and surgical guides.

Device Description

AI/ML Overview

The provided text is for a 510(k) premarket notification for dental impression materials. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance testing to established standards. It does not typically involve the kinds of human reader or AI performance studies you've requested.

Therefore, many of your requested items, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, and training set details, are not applicable to this specific regulatory document.

However, I can extract information related to acceptance criteria and the general study approach for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials - Premarket Notification (FOD#2203, 8/17/1998)	Designed and manufactured to perform in a manner substantially equivalent to predicate devices. Results demonstrated suitability for use as preliminary impression materials.
ISO 4823 (Dentistry -- Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007	Met applicable criteria, demonstrating suitability for use as preliminary impression materials.

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

Sample Size: Not explicitly stated in the provided text for a "test set" in the context of clinical or AI studies. The performance data refers to evaluation against standards, which typically involves laboratory testing of material samples, not a patient-based test set.
Data Provenance: Not applicable in the sense of country of origin or retrospective/prospective for this type of materials testing. Performance testing would be laboratory-based.

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

Not Applicable: This type of information is generally relevant for AI/clinical studies involving human interpretation or diagnosis. For dental impression materials, "ground truth" is established through physical and chemical property measurements against international standards.

4. Adjudication method for the test set

Not Applicable: Adjudication is typically used for resolving discrepancies in expert interpretations in clinical studies. For material performance, the "adjudication" is whether the material's properties meet the specified values in the standards.

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: No multi-reader multi-case comparative effectiveness study was conducted. This device is a physical material, not an AI or imaging diagnostic tool that would typically involve human readers.

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

No: This is a physical dental impression material, not a standalone algorithm.

7. The type of ground truth used

Standard-based Physical and Chemical Properties: The ground truth for this device's performance is derived from established international standards (ISO 4823) and FDA guidance for dental impression materials, which define acceptable ranges for physical and chemical properties (e.g., curing times, final hardnesses, recovery from deformation).

8. The sample size for the training set

Not Applicable: This device does not involve machine learning algorithms or a "training set" in that context.

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

Not Applicable: No training set as per a machine learning or AI context. The performance of the material itself is evaluated against predefined material science standards.

Summary

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K082157

Traditional Premarket Notification [510(k)] Kettosil®, Silginat® and Silginat® Strawberry Impression Materials

Confidential

AUG - 6 2008

	510(K) Summary
--	----------------

A. Submitter Information

Submitter's Name:	Kettenbach GmbH & Co. KG
Address:	Im Heerfeld 7
	D-35713
	Eschenburg, Germany
Phone Number:	(+49) 2774-705-58
Fax Number:	(+49) 2774-705-33
Contact Person:	Michaela Zinke
Date of Preparation:	June 19th , 2008

B. Device Name

Trade Name:	Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials
Common/Usual Name:	Impression Material
Classification Name:	Material, Impression (21 CFR 827.3660, Product Code: ELW)

C. Predicate Devices

Trade Name:	Freealgin, (K070700)
Trade Name:	Position Penta, Position Penta quick (K974231)
Trade Name:	Alginot (Kerr VPS Impression Material) (K 050604)

D. Device Description
Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials are addition-curing, elastomeric preliminary impression materials, to be used as an alternative to traditional alginate materials. They differ in their curing times, final hardnesses, and recovery from deformation.

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Page 17 of 364

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Kettosil®, Silginat® and Silginat® Strawberry Impression Materials

E. Intended Use

Indications for Use

Kettosil, Silginat and Silginat Strawberry are suitable for impressions in preparation of:

. Preliminary impression
Anatomical models .
Fabricating temporary crowns and bridges .
. Opposing dentition
. Fabricating simple removable prosthetic restorations
Orthodontic work .
. Fabricating removable retainers and splints
Case study models .
Producing models for the construction of trays for whitening solutions, bites and surgical guides.

F. Technological Characteristics Summary

The technological characteristics of Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials are substantially equivalent to the predicate device technological characteristics. Kettosil® and Silginat® (Silginat® Strawberry) Impression Materials and the predicate devices are addition-curing, elastomeric preliminary impression materials, designed and manufactured to be used as an alternative to traditional alginate materials.

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G. Performance Data

Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials - Premarket Notification (FOD#2203, 8/17/1998), ISO 4823 (Dentistry -- Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007. The results of device performance testing demonstrated that Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials are suitable for use as preliminary impression materials, to be used as an alternative to traditional alginate materials.. Kettosil® and Silginat®, Silginat® Strawberry) Impression Materials have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kettenbach GmbH & Co. KG C/O Mr. Steffan Preiss Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891

Re: K082157

Trade/Device Name: Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: July 29, 2008 Received: July 31, 2008

AUG - 6 2008

Dear Mr. Preiss:

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.

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Page 2 - Mr. Preiss

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); 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

M. Komneler Ledner
for M

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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SECTION I-D

Indications for Use

510(k) Number (if known): _ (082157

Device Name: Kettosil® and Silginat® (Silginat®, Silginat® Strawberry) Impression Materials

Indications for Use:

Kettosil, Silginat and Silginat Strawberry are suitable for impressions in preparation of:

� Preliminary impression
Anatomical models .
. Fabricating temporary crowns and bridges
. Opposing dentition
. Fabricating simple removable prosthetic restorations
. Orthodontic work
. Fabricating removable retainers and splints
◆ Case study models
Producing models for the construction of trays for whitening solutions, bites . and surgical guides.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR
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Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Cianci
--------------

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

Page 1 of 1

FOR 2157 510(k) Number:

Kettenbach GmbH & Co. KG

Page 15 of 364

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).