All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
Futar D Fast can be used for "small applications" because of its shorter working . time.
Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
Futar Scan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.

Device Description

Futar®, Futar® D, Futar® D Fast, Futar® D Slow, and Futar® Scan are syringeable, addition-curing, elastomeric bite registration materials which differ in their final hardnesses, curing times, and linear dimensional changes.

AI/ML Overview

The provided text is a 510(k) summary for the Futar® Bite Registration Materials. It describes the device and its intended use but does not contain a study that performs a direct comparison against a specific set of acceptance criteria in the manner requested (i.e., a table of acceptance criteria and reported device performance, information on sample size, expert ground truth establishment, MRMC studies, or standalone performance).

Instead, the submission demonstrates substantial equivalence to predicate devices by stating that the Futar® materials were evaluated in accordance with applicable criteria established by:

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
DIN 13903:2005 (Dentistry-Bite registration material)

The document asserts that "The results of device performance testing demonstrated that Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) are suitable for use as bite registration materials" and "perform in a manner substantially equivalent to that of the predicate devices."

Therefore, based solely on the provided text, I cannot complete the table or answer all specific questions as a detailed study report is not included. The FDA's 510(k) clearance letter (K081120) confirms that the device was found substantially equivalent based on the submitted information, which implies that the performance data, while not detailed here, met the necessary thresholds for substantial equivalence.

Here's what can be extracted and what cannot:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided 510(k) summary. The summary only generally states that the device was "evaluated in accordance with the applicable criteria established in [various standards]" and that "results of device performance testing demonstrated that Futar... are suitable for use as bite registration materials." No specific pass/fail criteria or numerical performance metrics are given.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. This type of detail is generally not included in a 510(k) summary for a material device unless a specific clinical study with expert evaluation was a critical component of demonstrating equivalence, which does not appear to be the case here.
Adjudication method: Not mentioned.
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 device is a dental material, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material.
The type of ground truth used: Not explicitly stated in terms of a "ground truth" for a diagnostic algorithm. The "performance data" refers to the physical and chemical properties and functional suitability of the material as assessed against the specified industry standards (ISO 4823, DIN 13903). These standards themselves define the "ground truth" for material properties like linear dimensional change, curing times, hardness, etc.
The sample size for the training set: Not applicable. This is a material, not a machine learning algorithm requiring a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a dental material, not a clinical study report for a diagnostic device or AI algorithm. Therefore, many of the requested details about "acceptance criteria" and "study" as they relate to diagnostic accuracy, expert review, or AI performance are not present. The "study" referenced is the performance testing of the material against established standards for dental impression materials to demonstrate substantial equivalence to predicate devices.

Summary

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Traditional Premarket Notification [510(k)] Futar® Bite Registration Materials

Image /page/0/Picture/1 description: The image contains the word "Kosllao" in a handwritten style on the left side. To the right of the handwritten word, the word "Confidential" is printed in a smaller, sans-serif font. The word "Confidential" suggests that the document or information associated with the image is private or sensitive.

510(K) Summary

MAY - 1 2008

A. Submitter Information Submitter's Name: Address:

Phone Number:

Contact Person:

Date of Preparation:

Fax Number:

Kettenbach GmbH & Co. KG Im Heerfeld 7 D-35713 Eschenburg, Germany (+49) 2774-705-58 (+49) 2774-705-33 Michaela Zinke March 27, 2008

B. Device Name
Trade Name:

Common/Usual Name: Classification Name:

Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials Bite Registration Material Material, Impression (21 CFR 827.3660, Product Code: ELW)

C. Predicate Devices Trade Name: Trade Name: Trade Name:
Futar® Occlusion, Futar® D Occlusion (K954281) R-SI-LINE® METAL-BITE® (K010926) Mega Bite Registration (K030776)
D. Device Description
Futar®, Futar® D, Futar® D Fast, Futar® D Slow, and Futar® Scan are syringeable, addition-curing, elastomeric bite registration materials which differ in their final hardnesses, curing times, and linear dimensional changes.

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E. Intended Use
Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials are intended for making accurate occlusal records. S

Indications for Use

All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
Futar D Fast can be used for "small applications" because of its shorter working . time.
Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
Futar Scan can also be used for an optical registration of occlusal data for . CAD/CAM/CIM systems without using powder.

F. Technological Characteristics Summary

The technological characteristics of Futar® (Futar® D, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials are substantially equivalent to the predicate device technological characteristics. Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) and the predicate devices are syringeable, addition-curing, elastomeric materials designed and manufactured for use as bite registration materials.

G. Performance Data

No performance standards have been established for this type of device. Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration 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, and DIN 13903:2005 (Dentistry-Bite registration material). The results of device performance testing demonstrated that

Kettenbach GmbH & Co. KG

Page 18 of 316

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and the state of the state

and the comments of the count

September 19.

のお気になる。

Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) are suitable for use as bite registration materials. Futar (Futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan) Bite Registration Materials have been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.

and the comments of the country of

and the comments of the comments of

and the control of the country

and the comments of the comments of

Kettenbach GmbH & Co. KG

Page 19 of 316

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kettenbach GmbH & Company KG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America Incorporated 1775 Old Highway 8 NW, Suite 104

New Brighton, Minnesota 55112-1891

Re: K081120

Trade/Device Name: Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 18, 2008 Received: April 21, 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.

MAY - 1 2008

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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 Office of Compliance at (240) 276-0115. Also, please note the regulation 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 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/industry/support/index.html.

Sincerely yours,

Snytte Y. Michau Davis

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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Traditional Premarket Notification [510(k)] Futar® Bite Registration Materials

SECTION I-D

Indications for Use

510(k) Number (if known): KO 8 1 20

Device Name: Futar® (Futar®, Futar® D, Futar® D Fast, Futar® D Slow, Futar® Scan) Bite Registration Materials

Indications for Use:

All Futar bite registration materials (Futar, Futar D, Futar D Fast, Futar D Slow, . Futar Scan) can be used for making accurate occlusal registrations.
Futar D materials (Futar D, Futar D Fast, Futar D Slow) can be used for . applications, which require a hard bite registration silicone.
Futar D Fast can be used for "small applications" because of its shorter working . time.
Futar D Slow can be used for time-consuming bite registrations because of its . longer working time.
Futar Scan can also be used for an optical registration of occlusal data for CAD/CAM/CIM systems without using powder.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Rame

(Division Sign-Off) Page 1 of 1 Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Kettenbach GmbH & Co. KG

510(k) Number: K0811

Page 15 of 316

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).