X-TRA FIL by VOCO GMBH | FDA 510(k) Summary

x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured.

AI/ML Overview

This document is a 510(k) summary for a dental restorative material called "x-tra fil". It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the way that, for example, an AI/ML medical device submission would.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for device performance is NOT available in this document.

Instead, this document focuses on demonstrating substantial equivalence based on:

Technological Characteristics: Stating that all components of "x-tra fil" are found in legally marketed predicate devices (K 040144, K 994056, K 926458, K 040769, K 030914, K 912425).
Prior Use: Arguing that the prior use of these components in legally marketed devices negates the need for additional cytotoxicity, mutagenicity, or biocompatibility studies.
Intended Use: Clearly defining the intended use as "posterior Class I and Class II cavities and core build-up."

To address your prompt as much as possible with the provided text, here's a breakdown of what is and is not present:

1. A table of acceptance criteria and the reported device performance

Not Applicable/Not Provided: This document does not present specific performance criteria or a table comparing them to reported device performance. It relies on substantial equivalence to predicate devices for its safety and effectiveness claims.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: No test set or associated sample size is mentioned, nor is any clinical study data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: No test set or ground truth establishment by experts is described.

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

Not Applicable/Not Provided: No test set or adjudication method is 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

Not Applicable/Not Provided: This device is a dental restorative material, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

Not Applicable/Not Provided: As this is a physical dental material, there is no algorithm or standalone performance testing in the sense of AI/ML devices.

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

Not Applicable/Not Provided: No specific ground truth methodology is mentioned for this type of device submission. The "truth" here is established primarily through the compositional similarity to previously approved materials.

8. The sample size for the training set

Not Applicable/Not Provided: There is no "training set" in the context of an AI/ML device for this submission. The device's safety and effectiveness are established through its chemical composition and the history of its individual components in other marketed devices.

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

Not Applicable/Not Provided: See explanation for point 8.

Summary of Device Rationale from the Document:

The manufacturer, VOCO GmbH, is asserting that "x-tra fil" is substantially equivalent to predicate devices. Their rationale is based on:

Identical Components: All components of "x-tra fil" are already found in several legally marketed devices (K 040144, K 994056, K 926458, K 040769, K 030914, K 912425).
Inference of Safety and Effectiveness: Because the components have a history of safe and effective use in other FDA-cleared devices, the manufacturer concludes that "additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." They believe this prior use and the provided performance data (though not detailed here) support the safety and effectiveness for its intended use.

The FDA's response confirms that they have reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices, allowing the manufacturer to market it, subject to general controls.

Summary

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Image /page/0/Picture/0 description: The image shows the word "VOCO" in a stylized font. Above the word is the text "K053391, jp/1951". The letters of the word "VOCO" are represented by geometric shapes. The "V" is an upside-down triangle with a rectangle cut out of the top, the "O" is a circle with a smaller circle cut out of the center, the "C" is a circle with a wedge cut out of it, and the last "O" is a circle with a smaller circle cut out of the center.

FEB 1 5 2006

	VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany			Anton-Flettner-Straße 1 - 327472 Cuxhaven · Germany
					+49 4721 719-0
				04721 719-109+49 4721 719-140
				www.voco.de info@voco.de

Ihr Zeichenyr ref.	Ihre Nachricht vomdtd.	Unser Zeichenour ref.	Datumdate
	510(k) SUMMARY
Contact:	Dr. Süs
Date prepared:	November 29, 2005
Trade orproprietary name:	x-tra fil
Classification name:	Tooth shade resin material (872.3690)
Predicate device:	Quixx Posterior Restorative K 040144
Device description:	x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured.
Intended use:	x-tra fil is indicated for posterior Class I and Class II cavities and core build-up.
Technologicalcharacteristics:	All of the components of x-tra fil are found in the legally marketed devices K 040144, K 994056, K 926458, K 040769, K 030914, K 912425.
	The prior use of all of the components of x-tra fil in legally marketed devices support our

The prior use of all of the components of x-tra fil in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of x-tra fil in legally marketed devices and the performance data and results provided support the safety and effectiveness of x-tra fil for the intended use.

VOCO GmbH, November 29, 2005

Dr. Michael Sus Mgr. for regulatory affairs

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2006

Dr. Michael Sus Manager Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany D-27472

Re: K053391

KUJ3391
Trade/Device Name: x-tra fil is Intended for light curing Class I and class II Posterior Fillings and Core Build-up Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 29, 2005 Received: December 7, 2005

Dear Dr. Sus:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bection 910(4) personally equivalent (for the referenced above and have determined and to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate collineree pror to may 20, 77 % a cordance with the provisions of Amendinens, of to devices that have ober (Act) that do not require approval of a premarket the rederal Pood, Drug, and Cosment Proc (Prov market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Feat - the girling 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 classified (500 a0010) in a controls. Existing major regulations affecting (FMA), it may oc subject to backs and readers, Title 21, Parts 800 to 898. In your device can be found in the Sous of Concerning your device in the Ecderal Register.

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Page 2 - Dr. Sus

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualled of a basetan requires with other requires mean that FDA has made a decemination until Js administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other frequires in of the Act of any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements, including progrises You must comply with an the Act 3 requirement 801); good manufacturing practice and listing (21 CFR Fall 807), labeling (21 CFR rate 77 //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821, 542 // 1ha requirements as set form in the quality Systems (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 5 (0(k) This letter will antw you to begin matically your device of your device to a premarket nothreation. The PDA miding of basically of 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 CH'R Part 801), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation
Please contact the Office of Compliance at (240) 276-0115. Also, please note presse contact une Office or Comphanos are (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 Division of Binar-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne

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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Indications for Use Statement

510(k) Number: K053391

Device Name: x-tra fil___

Indications for Use:

x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Cuomo

Division of Anesthesiology, General Hospital,
fection Control, Dental Devices
21000 Number 2/15/04

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.