Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.

Device Description

The subject device, Cercon® is a partially sintered ceramic blank composed of yttria stabilized zirconium oxide, (yttria stabilized tetragonal zirconia particle, Y-TZP). The subject device. Cercon® is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate all ceramic restorations. Cercon® blanks are zirconia based millable blanks (yttria-) stabilized zirconium oxide (zirconia) (Y-TZP)) that are used for all ceramic restorations for anterior and posterior locations. Specifically, Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.

The subject device, Cercon® is available in various shades (colors) for esthetics. Specifically, the subject Cercon® material is offered in the following shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and white.

The sintered restorations which are fabricated using the subject Cercon® material may be veneered with compatible veneering porcelains.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Dentsply Sirona Cercon®, which is a ceramic blank for dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices based on physical properties and biocompatibility, as clinical performance data was not submitted.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Set by ISO 6872:2015 for Type II Class 4)	Reported Device Performance (Cercon® K162888)
Flexural strength	Meets requirements per ISO 6872:2015
Chemical solubility	Meets requirements per ISO 6872:2015
Coefficient of thermal expansion, CTE	A4: 10.1 x 10^-6 K^-1 (25-500°C), 10.2 x 10^-6 K^-1 (25-600°C) C4: 10.0 x 10^-6 K^-1 (25-500°C), 10.1 x 10^-6 K^-1 (25-600°C)
Radioactivity	Meets requirements per ISO 6872:2015
Uniformity	Meets requirements per ISO 6872:2015
Shrinkage factor	Meets requirements per ISO 6872:2015
Freedom from extraneous materials	Meets requirements per ISO 6872:2015
Fracture Toughness	Meets requirements per ISO 6872:2015
Biocompatibility (Cytotoxicity)	Meets requirements per ISO 10993-5
Finished restoration quality (fit, margin, surface quality)	Evaluations of finished restorations fabricated with Cercon® and predicate Cercon ht (K112152) met predetermined acceptance criteria, and all finished dental restorations (Cercon®) were found to be crack-free after milling and sintering.

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

The document does not explicitly state the sample sizes for the physical property tests or the finished restoration evaluations. It mentions that testing was conducted "in accordance with ISO 6872:2015 (Dentistry - Ceramic materials)" and ISO 10993-5 for biocompatibility. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it can be inferred that these are bench tests conducted in a laboratory setting for regulatory submission.

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)

This information is not provided. The "ground truth" for the physical properties is defined by the ISO standards themselves. For the "predetermined acceptance criteria" for finished restoration quality, the number and qualifications of experts involved in setting or evaluating against these criteria are not mentioned.

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

The document does not describe any adjudication method. The testing appears to be based on physical measurements and evaluations against established standards, not on subjective interpretations requiring adjudication.

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

This is not applicable. The device (Cercon®) is a zirconia-based ceramic material for dental restorations, not an AI-assisted diagnostic or treatment planning tool. No MRMC study was conducted or is relevant to this device.

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

This is not applicable. The device is a material, not an algorithm. The performance described is inherent to the material properties and the final restoration's physical characteristics, not an algorithmic output.

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

The ground truth for the physical properties is established by international standards (ISO 6872:2015 and ISO 10993-5). For the finished restoration evaluations, the ground truth was based on "predetermined acceptance criteria," which would likely have been derived from dental engineering and clinical best practices for material performance. No pathology or outcomes data is mentioned here for establishing ground truth.

8. The sample size for the training set

This is not applicable. Cercon® is a material, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable, as there is no training set for this device.

Summary

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

February 24, 2017

Dentsply Sirona Mr. Karl Nittinger Senior Manager, Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404

Re: K162888

Trade/Device Name: Cercon Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 25, 2017 Received: January 26, 2017

Dear Mr. Karl Nittinger:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Susan Runna, DDS, MA

For Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K162888

Device Name Cercon®

Indications for Use (Describe)

Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Dentsply Sirona 221 West Philadelphia Street, Suite 60 York, PA 17404

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SECTION 5. 510(k) SUMMARY

for

Cercon® (K162888)

1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: February 22, 2017

2. Device Name:

• Proprietary Name:	Cercon®
• Common Name:	zirconia based millable blank
• Classification Name:	Porcelain powder for clinical use
• CFR Number:	21 C.F.R. 872.6660
• Device Class:	II
• Product Code:	EIH

1. Predicate Device:

Predicate Device Name	510(k)	Company Name
BruxZir™ Anterior	K143330	Prismatik Dentalcraft,Inc

Reference Device forBiocompatibility and composition	510(k)	Company Name
Cercon® Base	K051462	DeguDent GmbH
Cercon® ht	K112152	DeguDent GmbH

Reference Device for specificindications for use statement	510(k)	Company Name
CELTRA Press	K161269	DeguDent GmbH

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4. Description of Device:

The sintered restorations which are fabricated using the subject Cercon® material may be veneered with compatible veneering porcelains.

1. Indications for Use:
  Cercon® is indicated for all ceramic restorations for anterior and posterior locations, including crowns and 3-unit bridges in anterior and posterior regions.
1. Substantial Equivalence:
  The proposed Cercon® has similar indications for use as the predicate BruxZir™ Anterior, K143330. The indications are specifically defined as crowns and 3-unit bridges in anterior and posterior regions. The proposed Cercon® meets the requirement of flexural strength for this indication in accordance with ISO 6872:2015 (Dentistry -Ceramic materials) Type II Class 4 material. See Technological Characteristics for more details.

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Proposed Device	Primary Predicate Device	Secondary Predicate Device	Differences
Cercon®K162888	BruxZir™AnteriorK143330	CELTRA PressK161269
Indications for Use:Cercon® is indicatedfor all ceramicrestorations foranterior and posteriorlocations, includingcrowns and 3-unitbridges in anterior andposterior regions.	Indications for Use:The device isindicated for use bydental technicians inthe construction ofcustom made allceramic restorationsfor anterior andposterior location.	Indications for Use:CELTRA Press is an all-ceramic system for thecreation ofOcclusal veneersThin veneersVeneersInlaysOnlaysCrowns in the anterior andposterior region3-unit bridges in the anteriorand posterior region3-unit bridges in thepremolar region up to thesecond premolar as theterminal abutmentCrown, splinted crown or 3unit bridge up to the secondpremolar placed on top ofan implant abutment	The Indicationsfor Use for theproposed device,Cercon® includesadditional clarityand arespecificallydefined asintended for usein the fabricationof crowns and 3-unit bridges inanterior andposterior regions.

Table 5.1 Indications for Use Comparison

Composition comparison

The proposed device, Cercon® is primarily composed of Zirconium Oxide (ZrO2). Though the exact composition of the predicate BruxZir™ Anterior, K143330 is not available; the 510(k) Summary for the BruxZir™ Anterior 510(k) K143330 describes the predicate as zirconia milling blanks which are the same as the proposed device, Cercon®.

The proposed device, Cercon® consists of the same base (primary) composition as previously cleared devices, Cercon® Base (K051462) and Cercon® ht (K112152). Base composition for the proposed device Cercon® as well as reference devices Cercon® Base (K051462) and Cercon® ht (K112152) is Zirconium Oxide (ZrO2).

Technological Characteristics:

The proposed device, Cercon® was classified and tested in accordance with ISO 6872:2015 (Dentistry - Ceramic materials). Cercon® classification and clinical usage is noted below:

Type II: All other forms of ceramic products

Class 4:

Class 4a: Monolithic ceramic for three-unit prostheses involving molar restoration Class 4b: Partially or fully covered substructure for three-unit prostheses involving molar restoration

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PhysicalPropertiesISO 6872	Proposed DeviceCercon®K162888	Predicate DeviceBruxZir™ AnteriorK143330	ISO 6872:2015Type II Class 4	Differences
Flexural strength	Meets requirements per ISO6872:2015	Meets requirements, perISO 6872:2008	Meets requirements perISO 6872:2015	The proposed device Cercon®is a Type II class 4 device in
Chemical solubility	Meets requirements per ISO6872:2015	Not listed	Meets requirements perISO 6872:2015	accordance with ISO6872:2015 standard while theprimary predicate BruxZir™
Coefficient of thermalexpansion, CTE	A4$10.1×10^{-6} K^{-1}$ (25-500°C)$10.2×10^{-6} K^{-1}$ (25-600°C)C4$10.0×10^{-6} K^{-1}$ (25-500°C)$10.1×10^{-6} K^{-1}$ (25-600°C)	$11 x 10^{-6}$ / K(100-500°C)	$9.80±0.06 x 10^{-6} K^{-1}$(25°C-500°C)	Anterior, K143330 is a TypeII class 6 (per 510(k)summary) in accordance withISO 6872:2008 standard.Both the proposed deviceCercon® and the predicate
Radioactivity	Meets requirements per ISO6872:2015	Not listed	Meets requirements perISO 6872:2015	device, BruxZir™ Anterior(K143330) meet therequirements for the
Uniformity	Meets requirements per ISO6872:2015	Not listed	Not listed	appropriate type and class forits clinical usage. The
Mixing andCondensationProperties of type Iceramics	Not applicable	Not listed	Not listed	secondary predicate, CELTRAPress (K161269) is a type IIclass 4 material per ISO6872:2015 and meets the
Shrinkage factor	Meets requirements per ISO6872:2015	Not listed	Not listed	requirements for itsindications for use same as the
Glass transitiontemperature	Not applicable	Not listed	Not listed	proposed device, Cercon®.
Freedom fromextraneous materials	Meets requirements per ISO6872:2015	Not listed	Not listed
Fracture Toughness	Meets requirements per ISO6872:2015	Not listed	Not listed

Table 5.3 Physical Properties per ISO 6872 standard

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Both the proposed device Cercon® and the predicate device, BruxZir™ Anterior (K143330) meet the requirements for the appropriate type and class for its clinical usage. The secondary predicate, CELTRA Press (K161269) is a type II class 4 material per ISO 6872:2015 and meets the requirements for its indications for use same as the proposed device. Cercon®. The strength of the proposed Cercon® meets the requirement for ISO 6872:2015 for the defined indications for use.

7. Non-Clinical Performance Data:

Physical properties

In accordance with ISO 6872:2015 (Dentistry - Ceramic materials), the product must meet the requirements for the appropriate type and class for its clinical usage. Both the proposed device, Cercon®, and the predicate device, BruxZir™ Anterior (K143330), meet the requirements of the applicable type and class for its clinical usage (Table 5.3).

In addition to ISO testing, verification testing on finished restorations fabricated with the Cercon material was conducted.. All restorations were milled and sintered in accordance with the directions instructions for use and visual inspection for cracks was performed. All finished dental restorations were found to be crack-free.

Comparative evaluation of finished restorations fabricated using the subject Cercon® material and the predicate Cercon ht (K112152) material was also conducted. The restorations were evaluated for fit, margin, surface quality, and overall impression of dental objects (dental restorations). Results of the evaluation met the predetermined acceptance criteria.

The performance of the proposed device, Cercon® satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.

Biocompatibility Testing

Cytotoxicity testing according to ISO 10993-5 (Biological evaluation of medical devices) was completed to characterize the biocompatibility of the proposed device Cercon®. In addition, previously cleared devices (Cercon® Base, K051462 and Cercon® ht, K112152) were utilized to support biocompatibility for the proposed device Cercon®. Results of the testing support the biocompatibility of proposed device, Cercon®.

8. Clinical Performance Data:

Not applicable. No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Cercon®.

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9. Conclusion Regarding Substantial Equivalence:

The comparative information included in this section regarding the proposed device, Cercon®, supports substantial equivalence to the predicate device, BruxZir™ Anterior cleared under premarket notification K143330 . Substantial equivalence of the subject Cercon device is supported by the following determinative factors:

It has the same intended use and incorporates the same fundamental technology as the . primary predicate device (BruxZir™ Anterior, K143330).
. It has the same specific indications for use as secondary predicate device (CELTRA Press, K161269).
It has the same base (primary) composition Zirconium Oxide (ZrO2) as the reference . devices Cercon® Base (K051462) and Cercon® ht (K112152).
. It has similar technological characteristics as the predicate. The proposed device, Cercon® as well the predicate device, BruxZir™ Anterior, K143330 meet the requirement of the related type and class for its usage.

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.