The devices covered by this submission are milling blanks for the fabrication of custom-made all-ceramic dental restoration. The devices are manufactured from yttria-stabilized tetragonal zirconia (Y-TZP) complying with all applicable requirements of ISO 6872 (dental ceramics) and all requirements of ISO 13356 (ceramic materials for implants for surgery). They are provided in a partially sintered (pre-sintered) state. They are intended to be used by dental professionals e.g. dental technicians, for the fabrication of custom-made restorations for the sole use of a particular patient. These restorations are designed virtually by dental technicians using the CAD technology on the basis of intraoral scans or scans from impressions and/or models. The designed restorations are to be machined in all appropriate CAM Milling Centers out of Nacera Pearl blanks and finally sintered to full density. On basis of the available shades the finished restorations, sintered to full density, may be used as full-contour, all-ceramic prosthesis or may be veneered with suitable dental porcelains using the layering technique. Telescopic primary crowns will not be veneered. Nacera Pearl blanks are available in various shapes and dimensions such as discs, cylinders, bars, cubes, or other required forms, in order to meet the specifications of the different CAD/CAM milling machines used to generate the desired dental restorations. Nacera Pearl blanks are available in various shades in order to correspond to the different natural teeth colors and have a closer appearance to a natural tooth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nacera Pearl device:

Important Note: The provided text is a 510(k) summary for a dental material (Nacera Pearl), not a medical device in the typical sense of AI algorithms or diagnostic tools. Therefore, many of the requested categories (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this type of submission. This document describes a material's physical and chemical properties in comparison to existing, legally marketed materials.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties of the Nacera Pearl material to legally marketed predicate devices. The "acceptance criteria" are implied to be that the properties of Nacera Pearl are "comparable" to those of the predicate devices, as assessed against established international standards.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance (Comparative)

Property	Acceptance Standard (Implied)	Nacera Pearl Performance (Relative to Predicates)
Material Composition	Porcelain powder Y-TZP (same as predicates)	Same
Further Processing	Milling in CAM milling centers using CAD/CAM tech	Same
Types	Pre-sintered blanks	Same
Physical Properties	ISO 13356 and ISO 6872 (dental ceramics)	Complies with these standards
Density	Comparable to predicates (ISO 13365)	Comparable
Microstructure	Comparable to predicates (ISO 13365)	Comparable
Flexural Strength	Comparable to predicates (ISO 13365)	Comparable
Radioactivity	Comparable to predicates (ISO 13365)	Comparable
Thermal Expansion	Comparable to predicates (ISO 13356)	Comparable
Chemical Solubility	Comparable to predicates (ISO 13356)	Comparable
Open Porosity	Comparable to predicates	Comparable
Tensile Strength	Comparable to predicates	Comparable
Elastic Limit	Comparable to predicates	Comparable
Bending Strength	Comparable to predicates	Comparable
Young's Modulus	Comparable to predicates	Comparable

The "study" that proves the device meets these criteria is the Performance Testing conducted by the submitter.

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

Sample Size for Test Set: The document does not specify exact sample sizes for the material testing. Terms like "a series of testing" are used, implying multiple measurements were taken for each property to ensure reproducibility and reliability, but specific n values are not provided.
Data Provenance: Not explicitly stated. Given the submitter (Doceram Medical Ceramics GmbH) is based in Germany, it is highly likely the testing was performed in Germany or an affiliated European laboratory. The tests are against international standards (ISO), which implies a standardized, global approach to testing, but the country of origin of the data generation itself is not detailed. The data would be considered prospective in the sense that the material was manufactured for the purpose of this testing.

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. This is a material science characterization, not an expert-based diagnostic assessment. The "ground truth" is established by physical and chemical measurements using calibrated laboratory equipment and standardized testing protocols (ISO 13365, ISO 13356). There are no human experts involved in subjectively establishing "ground truth" as would be the case for medical image interpretation.

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

Not Applicable. There is no adjudication method as this is not an interpretive diagnostic study. The results are quantitative measurements against predefined physical and chemical 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

Not Applicable. This is a material testing conformity assessment, not an MRMC or AI-assisted diagnostic study.

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

Not Applicable. This device is a dental material, not an algorithm.

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

The "ground truth" for this submission are the physical, chemical, and mechanical properties determined through standardized laboratory testing (e.g., density, flexural strength, thermal expansion, chemical solubility) as defined by ISO 13356 and ISO 6872. These are objective, measurable properties.

8. The sample size for the training set

Not Applicable. This is a physical product (dental material), not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 26, 2015

Doceram Medical Ceramics GmbH Mr. Stefan Drude Head of Regulatory Affairs Hesslingsweg 65-67. Dortmund 44309 GERMANY

Re: K143071

Trade/Device Name: Nacera Pearl Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 7, 2015 Received: May 11, 2015

Dear Mr. Drude:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for DOCERAM Medical Ceramics. The logo is in a rectangular box with the word "DOCERAM" in bold, sans-serif font. There is a yellow triangle above the "O" in DOCERAM and a yellow line below the word. Below the box, the words "MEDICAL CERAMICS" are written in a smaller, sans-serif font.

Indications for Use

K143071 510(k) Number (if known):

Device Name: Nacera Pearl

Indications For Use:

Nacera Pearl blanks are indicated for the fabrication of single crowns and bridgework:

fully anatomical single crowns and bridgework (FCZ)
Partially veneered or fully veneered crowns and bridges
Inlays, onlays, and Maryland bridges
Primary telescopic crowns

for anterior and posterior applications

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S 2015.06.25 12:39:57 -04'00'

DOCERAM Medical Ceramics GmbH

Fax:

Phone: +49 (0) 231 / 92 56 68 - 0 +49 (0) 231 / 92 56 68 - 60 info@doceram-medical.com www.doceram-medical.com

Hesslingsweg 65 - 67 D - 44309 Dortmund Germany

Commerzbank Dortmund BLZ 440 400 37 · KTO 28 27 020 BIC Code: COBADEFF440 IBAN: DE92440400370282702000

Qualitätsmanagementsystem Certified Company DIN EN ISO 13485 für Medizinprodukte

DCM.BP.02/2012 DMc

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510[k] Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92

Submitter Name	DOCERAM Medical Ceramics GmbH
Submitter Address	Hesslingsweg.65-67, D - 44309 Dortmund
Phone Number	+49-231-925025952
Fax Number	+49-231-92566870
Contact Person	Stefan Drude
Date summary was prepared	July 10, 2014
Device Trade Name(s)	Nacera Pearl
Classification Name	Porcelain Powder for Clinical Use
C.D.R. section number	872.6660
Product Code	EIH
Regulatory Class	class II
Predicate Devices	K080195	Nacera Z, Nacera Z Medium
	K132102	BeCe CAD Zirkon HT+
	K133213	StarCeram Z-Med
	K117210	ZENO Zr Disc
Device Description	The devices covered by this submission are milling blanks forthe fabrication of custom-made all-ceramic dental restoration
	The devices are manufactured from yttria-stabilized tetragonalzirconia (Y-TZP) complying with all applicable requirements ofISO 6872 (dental ceramics) and all requirements of ISO 13356(ceramic materials for implants for surgery).
	They are provided in a partially sintered (pre-sintered) state
	They are intended to be used by dental professionals e.g. den-tal technicians, for the fabrication of custom-made restorationsfor the sole use of a particular patient.
	These restorations are designed virtually by dental techniciansusing the CAD technology on the basis of intraoral scans orscans from impressions and/or models.
	The designed restorations are to be machined in all appropriateCAM Milling Centers out of Nacera Pearl blanks and finally sin-tered to full density.

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On basis of the available shades the finished restorations, sin-tered to full density, may be used as full-contour, all-ceramicprosthesis or may be veneered with suitable dental porcelainsusing the layering technique. Telescopic primary crowns will notbe veneered.
Nacera Pearl blanks are available in various shapes and di-mensions such as discs, cylinders, bars, cubes, or other re-quired forms, in order to meet the specifications of the differentCAD/CAM milling machines used to generate the desired dentalrestorations,.
Nacera Pearl blanks are available in various shades in order tocorrespond to the different natural teeth colors and have a clos-er appearance to a natural tooth
Indications for Use
Nacera Pearl blanks are indicated for the fabrication of singlecrowns and bridgework:
➤ fully anatomical single crowns and bridgework (FCZ)
➤ Partially veneered or fully veneered crowns and bridges
➤ Inlays, onlays, and Maryland bridges
➤ Primary telescopic crowns
for anterior and posterior applications

Comparison of Indications for Use

Device name	Intended Use
Doceram MedicalCeramicsNacera Pearl	Fabrication of all-ceramics custom-made restorations for the sole use of particular pa-tients. It is recommended for:➤ fully anatomical single crowns and bridgework (FCZ)➤ Partially veneered or fully veneered crowns and bridges➤ Inlay, onlays, and Maryland bridges➤ Primary telescopic crowns➤ for anterior and posterior segment restorations
Doceram Medical Ce-ramicsNacera Z / Z Medium	Nacera Z and Nacera Z Medium is specially designed for use as framework(substructure) for dental restorations, single tooth or bridge type applicationat anterior and posterior locations.It is prepared for machining by use of CAM-techniques.
H.C. StarckStarCeram ® Z-Med	Fabrication of➤ crowns,➤ multi-unit bridges,➤ inlay bridges➤ all- ceramic restorations.applications include both anterior and posterior bridges

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BEGOBeCe CAD Zirkon HT+	Fabrication of all-ceramics custom-made restorations for the sole use of particular pa-tients. It is recommended for:> fully anatomical single crowns and bridgework (FCZ)> Partially veneered or fully veneered crowns and bridges> Dentin core crowns and bridges
	> Maryland bridges
	> Telescopic crowns (primary part)
Wieland	Fabrication of all-ceramics restorations for the sole use of particular pa-
ZENO Zr	tients. It is recommended for:
	single-tooth and bridgework restorations like crowns and bridges with one or two pon-tics, which can be used in the anterior as well as in the posterior tooth region.

Comparison of Technological Characteristics

Device name	Material Composition	Further Processing	Types	Physical Properties
DMCNacera Pearl	Porcelain powder Y-TZP	Milling in CAM millingcenters usingCAD/CAM technique	pre-sintered blanks	ISO 13356 and ISO6872
DMCNacera Z / Z Medium	Porcelain powder Y-TZP	Milling in CAM millingcenters usingCAD/CAM technique	pre-sintered millingblank	ISO 13356 and ISO6872
H.C. StarckStarCeram ® Z-Med	Porcelain powder	Milling in CAM millingcenters usingCAD/CAM technique	pre-sintered millingblank	ISO 13356 and ISO6872
BEGOBeCe CAD Zirkon HT+	Porcelain powder	Milling in CAM millingcenters usingCAD/CAM technique	pre-sintered millingblank	ISO 13356 and ISO6872
WielandZENO Zr	Porcelain powder	Milling in CAM millingcenters usingCAD/CAM technique	partially (pre-)sintered blank	ISO 13356 andISO 6872

The main differences between the subject device and the noted predicates are based on slight variations in shade (the end sintered dental restorations shade differences are caused by the chemical composition differing mass fractions of the ,oxide' components) as well as physical properties such as density and flexural strength.

Performance Testing In order to demonstrate comparability of Nacera Pearl dental materials to the predicate devices a series of testing was performed according to ISO 13365 - in particular density, microstructure, flexural strength, and radio activity. Thermal expansion and chemical solubility was also performed according to ISO 13356. Open porosity, tensile strength, elastic limit, bending strength, Young's modulus comparative testing was also performed.

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Submitter: Doceram Medical Ceramics GmbH

The results of this testing showed that the physical properties and performance of the subject device are comparable to the identified predicates.

SE Conclusion: In conclusion, it has been shown that all devices are dental materials manufactured from the same porcelain powder Y-TZP, have comparable indications for use, technical, physical, chemical, and biological properties and characteristics, and have the same aesthetic and diagnostic function. Therefore, it can be demonstrated that Nacera Pearl dental materials are substantially equivalent to the predicate dental devices, Nacera Z, Nacera Z Medium, BeCe CAD Zirkon HT+, StarCeram Z-Med, and ZENO Zr.

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.