METOXIT CAM-BLANKS by Metoxit AG

Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals. Metoxit CAM-Blanks are designed for the manufacturing of substructures for all-ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining technique or the copying technique, then sintered to full density and strength and for the sole use of the particular patients. Metoxit CAM-Blanks are designed for the use as single tooth restorations or bridgeworks with up to two pontics in the anterior as well as in the posterior teeth region.

AI/ML Overview

This document is a 510(k) Premarket Notification for Metoxit CAM-Blanks, a dental ceramic device. It seeks to demonstrate substantial equivalence to previously marketed devices rather than establishing novel performance criteria through a clinical study. Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria, a test set, ground truth, MRMC study, and training set is not applicable in the context of this 510(k) submission.

Here's why and what is available in the document:

Purpose of a 510(k) Submission:
A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and materials. It often does not require new clinical studies to establish safety and effectiveness if the device is sufficiently similar to existing ones.

Regarding the Absence of Requested Information:

Acceptance Criteria and Reported Device Performance (Table): Not applicable. The submission does not define new performance acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, it claims identical technological characteristics and intended use to predicate devices.
Sample Size and Data Provenance (Test Set): Not applicable. There is no "test set" in the sense of a set of cases used for evaluating an AI algorithm's performance. The "data" here refers to the device's material properties and manufacturing process, which are compared to predicate devices. There's no clinical data or image data provenance mentioned.
Number of Experts and Qualifications (Ground Truth for Test Set): Not applicable. No ground truth was established by experts for a test set in this kind of submission.
Adjudication Method: Not applicable. There was no need for adjudication as no expert ratings for a test set were generated.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study would be relevant for evaluating AI-driven diagnostic or interpretative devices, which Metoxit CAM-Blanks are not. There is no mention of human readers or AI assistance.
Standalone Performance Study: Not applicable. The device itself is a physical dental material, not a software algorithm that would have standalone performance.
Type of Ground Truth Used: Not applicable. No "ground truth" (e.g., pathology, outcomes data) was established for an evaluation set. Safety and effectiveness are inferred from equivalence to predicate devices and their known performance.
Sample Size for Training Set: Not applicable. This device is not an AI algorithm requiring a training set.
How Ground Truth for Training Set was Established: Not applicable.

What the Document Does Provide (Relevant to a 510(k) Summary):

Device Trade Name: Metoxit CAM-Blanks
Device Common Name: CAM-Blanks
Device Classification Name: Porcelain Powder for Clinical Use
Intended Use: Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations.
Limitations/Indications of Use (Table 1 on page 4): This table specifies the types of restorations (single unit crowns, bridges with varying pontics) the blanks can be used for, categorized by material (TZP-A, Al-999, TZP) and process chain (porous blank or dense blank). For example, TZP-A porous blanks can be used for bridges with up to 2 pontics in both anterior and posterior regions.
Legally Marketed Predicate Devices: K013230, K051462 - Cercon base; K051462 Cercon base colored; K050903 XAWEX G100; K022996 Vita YZ cubes; K051705 Ivoclar ZIRCAD; K052130 Vita AL cubes; K062506 Sirona InCoris AL; K001815 DCS DC-Zirkon.
Technological Characteristics Comparison: The document explicitly states: "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They are made from the same materials and have the same intended use."
Conclusion of Substantial Equivalence: The submission concludes that Metoxit CAM-Blanks are as safe and effective as the predicate devices and are substantially equivalent because they share the same intended use and technological characteristics, raising no new questions regarding safety and effectiveness.

This 510(k) demonstrates "substantial equivalence" based on direct comparison of materials and intended use with existing, approved devices, rather than through new clinical performance studies against defined acceptance criteria.

Summary

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

Image /page/0/Picture/0 description: The image shows the word "METOXIT" in a stylized, blocky font. The letters are bold and black, contrasting with the white background. The 'O' in the word is represented by a square shape.

high tech ceramics

4 1 1 - 1 - 1 - 1 - PREMARKET NOTIFICATION - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Device

Metoxit CAM-Blanks

K072569

510 (k) Summary

007 ຊຶ່ງ 2007

SubmissionCorrespondent:	Emergo Group, Inc.1705 S. Capital of Texas HwySuite 500Austin, TX 78746
	Phone: 512-327-9997Fax: 512-327-9998Email: iangordon@emergogroup.comContact: Ian GordonSr. Vice President
Submission Sponsor:	Metoxit AGEmdwiesenstrasse 6CH-8240 Thayngen
	Phone: +41 52 645 0101Email: Stefan.koebel@metoxit.comContact: Dr. Wolfram Weber, General Manager
Date summary prepared:	July 31, 2007
Device trade name:	Metoxit CAM-Blanks
Device common name:	CAM-Blanks
Device classification name:	Porcelain Powder for Clinical Use
Legally marketed devicesto which the device issubstantially equivalent:	K013230, K051462 - Cercon baseK051462 Cercon base coloredK050903 XAWEX G100K022996 Vita YZ cubesK051705 Ivoclar ZIRCADK052130 Vita AL cubesK062506 Sirona InCoris ALK001815 DCS DC-Zirkon
Description of the device:	Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxidestabilized tetragonal zirconium-oxide polycrystals.Metoxit CAM-Blanks are designed for the manufacturing of substructuresfor all-ceramic dental appliances. The dental appliance is machined eitherby CAD/CAM machining technique or the copying technique, then sinteredto full density and strength and for the sole use of the particular patients.Metoxit CAM-Blanks are designed for the use as single tooth restorationsor bridgeworks with up to two pontics in the anterior as well as in theposterior teeth region.
Intended use of the device:	Metoxit blanks are indicated for use as a substructure for porcelain fusedceramic fixed dental restorations

Technologicalcharacteristics:	The technological characteristics between the predicate and proposeddevices are identical. There is no difference in fundamental scientifictechnology. They are made from the same materials and have the sameintended use.
Conclusions:	By definition, a device is substantially equivalent when the device has thesame intended use and the same technological characteristics as thepredicate device.
	There are no significant differences between the Metoxit CAM - Blanksand the predicate devices and therefore, the Metoxit CAM-Blanks do notraise any questions regarding safety and effectiveness.
	The Metoxit CAM-Blanks, as designed, are as safe and effective as thepredicate device, and the device is determined to be substantiallyequivalent to the referenced predicate devices currently on the market.

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

Image /page/1/Picture/0 description: The image shows the word "METOXIT" in a stylized, blocky font. Below the word, the phrase "high tech ceramics" is written in a smaller, sans-serif font. The text is black against a white background, creating a high-contrast visual.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2007

Metoxit AG C/O Mr. Ian Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

Re: K072569

Trade/Device Name: Metoxit CAM-Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 6, 2007 Received: September 12, 2007

Dear Mr. Gordon:

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.

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

Page 2- Mr. Gordon

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" (21 CFR 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,

Nusf R.S. Ogle

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

{4}------------------------------------------------

510(k) PREMARKET NOTIFICATION

Indications for Use State

510(k) Number:

1564

Indications for Use:

Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.

			Table 1: Indications of use and maximum number of pontics.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	.	Comments of the program and the comments of lines and the bearing

Process chain	Material	Single unit crowns		Bridges, number of pontics
		Anterior	Posterior	Anterior	Posterior
Porous blank ismachined toenlargedframework, thensintered andveneered.	TZP-A	X	X	2	2
	Al-999	X	X	1	-
Dense blank ismachined tonet-shapeframework, thenveneered.	TZP	X	X	2	2
	TZP-A	X	X	2	2

X indicated; - not indicated; digits show maximum number of pontics.

All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Runse

on Sign-Off) ion of Anesthesiology, General Hospital, John Control, Dental De

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.