NACERA Z AND NACERA Z MEDIUM by DOCERAM MEDICAL CERAMICS GMBH

Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.

Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.

It is prepared for machining by use of CAM-techniques.

The machined frameworks like dental crown and bridge works are sintered to full density.

Device Description

Nacera Z is a ceramic material for dental restorations.

Nacera Z is composed of partially sintered yttrium oxide stabilized zirconium oxide.

Nacera Z is designed for manufacturing all-ceramic dental restorations (substructures) for the sole use of particular patients. It is machined on milling centers by use of CAD/CAM techniques for design and processing.

Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.

Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.

Nacera Z is delivered as presintered white blanks, which change during final sintering and effected by minimal alterations of oxide composition to characteristic hues from white to light pearl. That offers an outstanding basis for aesthetical restorations.

All above mentioned advantages ensure safe, resistant, and effective dental restorations.

Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.

Nacera Z meets all applicable requirements of International standard ISO 6872:1999 "Dental ceramic". It meets even the the international standard 13356:1997 "Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirkonia" for biocompatible and biostable dental implants and restorations.

The partially sintered Nacera Z blanks are fabricated in two different types, distincted by their presintered density and hue, each type available as disks with different dimensions depending upon custormer's request.

Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.

Nacera Z is available in two different types. Nacera Z and Nacera Z Medium. The differ in hue effected by slightly changed ratios of the oxides in order to meet individual customer's requirements. Both types are available in both presintered densities 3,09 g/cm³ and 3,20 g/cm³

AI/ML Overview

The provided text describes a premarket notification 510(k) for a dental ceramic material called Nacera Z and Nacera Z Medium. This document is a regulatory submission for a medical device and, as such, does not contain information about acceptance criteria or a study proving performance against those criteria in the way envisioned by the request (e.g., clinical study with statistical outcomes).

The document focuses on establishing substantial equivalence to a legally marketed predicate device (Zerion beta) and demonstrating compliance with relevant international standards for dental ceramics and implants.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present.

Acceptance Criteria and Device Performance (Based on Regulatory Standards):

Acceptance Criteria (from International Standards)	Reported Device Performance
Meets "Dental ceramic" standard ISO 6872:1999	Nacera Z meets all applicable requirements of ISO 6872:1999
Meets "Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirkonia" standard ISO 13356:1997 for biocompatible and biostable dental implants and restorations	Nacera Z meets the international standard 13356:1997
Biocompatible	Nacera Z is biocompatible
Biostable	Nacera Z is biostable
Insoluble in water	Nacera Z is insoluble in water
Outstanding high strength of densely sintered ceramic restorations	Due to the outstanding high strength of densely sintered ceramic restorations, Nacera Z enables finely shaped, precise, and filigree framework
Enables design of finely shaped, precise, and filigree framework	Enables design of finely shaped, precise, and filigree framework
Provides outstanding basis for aesthetical restorations (hue characteristics)	Changes during final sintering to characteristic hues from white to light pearl, offering an outstanding basis for aesthetical restorations
Safe, resistant, and effective dental restorations	All mentioned advantages ensure safe, resistant, and effective dental restorations

Information Not Available in the Provided Text:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not described in the regulatory summary. The "study" here refers to compliance with international standards, which would involve material testing, not human-subject testing or image-based diagnostic evaluation.
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, as this is a material science device, not a diagnostic device requiring expert interpretation of images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a material science device.
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, as this is a dental ceramic, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental ceramic and not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For material properties, the "ground truth" would be established through laboratory testing against the specifications defined by the ISO standards.
The sample size for the training set: Not applicable, as this is a material science device, not a machine learning model.
How the ground truth for the training set was established: Not applicable, as this is a material science device, not a machine learning model.

Summary of what the document does provide:

The document is a 510(k) summary for a dental ceramic material called Nacera Z. It states that the device is designed for dental restorations (single tooth crowns or bridgeworks) and is biocompatible, biostable, and insoluble in water. The key "proof" of meeting acceptance criteria comes from its stated compliance with two international standards:

ISO 6872:1999 "Dental ceramic": Nacera Z "meets all applicable requirements" of this standard.
ISO 13356:1997 "Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirkonia": Nacera Z "meets" this standard for biocompatible and biostable dental implants and restorations.

The "study" or evidence of performance is implicitly based on laboratory testing that demonstrates the material's properties (strength, stability, biocompatibility, etc.) conform to the specifications and tests outlined in these ISO standards. The submission relies on this compliance, along with substantial equivalence to a predicate device (Zerion beta, K061804), for regulatory clearance. It does not involve clinical trials or human reader studies.

Summary

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Kogdq5

Premarket Notification 510(k)

Nacera Z

Section VI

APR 2 8 2008

510 (K) Summary

Submitter of 510 (k):	DOCERAM Medical Ceramics GmbHHesslingsweg 65-6744309 DortmundPhone: +49-231-925668-0Telefax +49-231-925668-60e-mail info@doceram-medical.comWeb: www.doceram-medical.com
Contact person	Holger WampersGeneral ManagerPhone: +49-231-925668-63Telefax +49-231-925668-60e-mail h.wampers@doceram-medical.com
Date of Summary	November 06, 2007
Trade Name	Nacera ZNacera Z Medium
Classification name:	Porcelain Powder for clinical use
Product code	EIH
C.O.R. section	872.6660
Classification	Class II
Legally marketed equvalent device	Zerion beta
510 (k) number	K061804
Device Description	Nacera Z is a ceramic material for dental restorations.Nacera Z is composed of partially sintered yttrium oxide stabi-lized zirconium oxide.Nacera Z is designed for manufacturing all-ceramic dental res-torations (substructures) for the sole use of particular patients.It is machined on milling centers by use of CAD/CAM tech-niques for design and processing.

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Nacera Z is designed for dental restorations like single tooth crowns or bridgeworks. It is biocompatible, biostable, and insoluble in water.

Due to the outstanding high strength of densely sintered ceramic restorations Nacera Z enables dental technicians to design finely shaped, precise, and filigree framework.

All above mentioned advantages ensure safe, resistant, and effective dental restorations.

Nacera Z substructures are well suited to be veneered with suitable dental porcelains using the layering technique.

Nacera Z is delivered in various shapes and dimensions in order to meet individual customer requirements. Possible shapes are: disk, cylinder, cube.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2008

Mr. Holger Wampers Managing Director DOCERAM Medical Ceramics GmbH Hesslingsweg 65-67 D-44309 Dortmund GERMANY

Re: K080195

Trade/Device Name: Nacera Z, Nacera Z Medium Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 2, 2008 Received: February 19, 2008

Dear Mr. Wampers:

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. Wampers

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination it as your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Fedurements. 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); $1, CFR 1000, 1050 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,

Sustite Y. Mchan Duid

Olivia Liao, Ph.D.

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 IV

Indications for Use

17680195 510(k) Number (if known):

Device Name: Nacera Z, Nacera Z Medium

Indications for Use:

Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.

It is prepared for machining by use of CAM-techniques.

The machined frameworks like dental crown and bridge works are sintered to full density.

Prescription Use Prescription Ose
(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)

DRH_ Office of Device_Evaluation (ODE) Concurrence of C

Karin Malsky for MSK

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

510(k) Number: K080195

section IV

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.