CELTRA Press is an all-ceramic system for the creation of Occlusal veneers Thin veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior and posterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

Device Description

CELTRA Press is a high-strength zirconia-reinforced lithium silicate glass ceramic material that can be used for the fabrication of highly aesthetic all-ceramic restorations by using the hot-pressing technique in dental labs. The homogeneous, industrially produced ingots are available in both high and low translucency for full-contour application. They are pressing furnaces using press investments material which do not form surface reaction layer to obtain tooth-colored, highly aesthetic, all-ceramic restorations. Subsequently, CELTRA Press may be veneered, stained and/or glazed with compatible CELTRA Press veneering porcelains.

AI/ML Overview

The provided document describes the mechanical properties and biocompatibility of a dental ceramic material called CELTRA Press, not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and ground truth for training set) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance for CELTRA Press

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Proving Performance
Material Classification	Conforms to ISO 6872:2015, Type II, Class 4a (Monolithic ceramic for three-unit prostheses involving molar restoration) and Class 4b (Partially or fully covered substructure for three-unit prostheses involving molar restoration)	CELTRA Press is a Type II Class 4 device.	Non-clinical bench testing in accordance with ISO 6872:2015.
Flexural Strength	Minimum mean flexural strength of 500 MPa for Type II Class 4 materials (as per ISO 6872:2015)	Meets the requirement for Type II Class 4 materials.	Non-clinical bench testing in accordance with ISO 6872:2015.
Chemical Solubility	Conforms to ISO 6872:2015 requirements	Conforms to ISO 6872:2015	Non-clinical bench testing in accordance with ISO 6872:2015.
Coefficient of Thermal Expansion (CTE)	Conforms to ISO 6872:2015 requirements	Conforms to ISO 6872:2015	Non-clinical bench testing in accordance with ISO 6872:2015.
Radioactivity	Conforms to ISO 6872:2015 requirements	Conforms to ISO 6872:2015	Non-clinical bench testing in accordance with ISO 6872:2015.
Biocompatibility	Conforms to ISO 10993-1, 10993-5, and 10993-18	Results of testing support the biocompatibility of CELTRA Press.	Toxicological testing completed according to ISO 10993-1, 10993-5, and 10993-18.

Breakdown of Study Information:

Sample size used for the test set and the data provenance: Not applicable to this type of device (material properties are tested, not a diagnostic algorithm). The document states "non-clinical bench testing conducted." Specific sample sizes for each physical property test are not detailed in this summary. Data provenance is implied to be from laboratory testing performed by the manufacturer or a contracted lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by objective, standardized physical and chemical measurements according to ISO standards, not expert consensus.
Adjudication method for the test set: Not applicable for material property testing.
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 not an AI/ML powered medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered medical device.
The type of ground truth used:
- For Physical Properties (Flexural Strength, Chemical Solubility, CTE, Radioactivity): The ground truth is defined by the objective measurement standards and thresholds specified in ISO 6872:2015 (Dentistry - Ceramic materials).
- For Biocompatibility: The ground truth is established by the accepted methodologies and endpoints defined in ISO 10993-1, 10993-5, and 10993-18 (Biological evaluation of medical devices).
The sample size for the training set: Not applicable. This is not an AI/ML powered medical device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered medical device.

Summary

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

August 16, 2016

Dentsply Sirona Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K161269

Trade/Device Name: CELTRA Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: July 5, 2016 Received: July 6, 2016

Dear Ms. Helen Lewis:

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

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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.

Susan Runno DDS, MA

Tina Kiang, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name CELTRA Press

Indications for Use (Describe) CELTRA Press is an all-ceramic system for the creation of Occlusal veneers Thin veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior and posterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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SECTION 5. 510(k) SUMMARY for CELTRA Press

Submitter Information:

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

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: 24 June 2016

Device Name:

●	Proprietary Name:	CELTRA Press
●	Common Name:	All-ceramic system
●	Classification Name:	Porcelain powder for clinical use
●	CFR Number:	21 C.F.R. 872.6660
●	Device Class:	II
●	Product Code:	EIH

Predicate Device:

Predicate Device Name	510(k)	Company Name
IPS e.max Press and IPS e.max Press Multi	K120134	Ivoclar Vivadent AG
Reference Device for BiocompatibilityQuattro Porcelain System	K091706	DENTSPLY Prosthetics

Description of Device:

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Indications for Use:

Substantial Equivalence:

The proposed CELTRA Press has the similar indications for use as the predicate IPS e.max Press and IPS e.max Press Multi (K120134) with the exception of an indication for 3-unit bridges in the posterior region. The proposed CELTRA Press meets the requirement of flexural strength for this indication in accordance with ISO 6872:2015 (Dentistry - Ceramic materials).

Proposed Device	Predicate Device	Differences
CELTRA Press system	IPS e.max Press and IPSe.max Press Multi, K120134
Indications for Use:CELTRA Press is an all-ceramic system for the creationofOcclusal veneersThin veneersVeneersInlaysOnlaysCrowns in the anterior andposterior region3-unit bridges in the anteriorand posterior region3-unit bridges in the premolarregion up to the secondpremolar as the terminalabutmentCrown, splinted crown or 3 unitbridge up to the secondpremolar placed on top of animplant abutment.	Indications for Use:IPS e.max Press and IPS e.maxPress Multi is an all-ceramicsystem for the creation ofOcclusal veneersThin VeneersVeneersInlaysOnlaysCrowns in the anterior andposterior region3-unit bridges in the anteriorregion3-unit bridges in the premolarregion up to the secondpremolar as the terminalabutmentCrown, splinted crown or 3 unitbridge up to the secondpremolar placed on top of animplant abutment.	The proposed deviceCELTRA Press is indicatedfor 3-unit posterior bridgeswhile the predicate IPSe.max Press and IPSe.max Press Multi,K120134 is not indicatedfor this use based on itsISO 6872 standardclassification.

Technological Characteristics:

The proposed CELTRA Press was classified and tested in accordance with ISO 6872:2015 (Dentistry – Ceramic materials). CELTRA Press classification and clinical usage is noted below: Type II: All other forms of ceramic products

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 DeviceCELTRA Press	PredicateDeviceIPS e.maxPress and IPSe.max PressMulti, K120134	Differences
Type andClassificationFlexural StrengthChemical SolubilityCoefficient ofThermal Expansion,CTERadioactivity	Conforms to ISO6872	Conforms toISO 6872	The proposed device CELTRAPress is a Type II class 4 devicewhich requires a minimum meanflexural strength of 500MPawhile the predicate IPS e.maxPress and IPS e.max PressMulti, K120134 is a Type II class3 devices based on its ISO 6872standard classification.

The strength of the proposed CELTRA Press meets the reguirement for Type II Class 4 (materials with a minimum mean flexural strength of 500 MPa), which by definition includes three unit prostheses.

Non-Clinical Performance Data:

Physical Properties:

In accordance with ISO 6872:2015 (Dentistry - Ceramic materials), the product must meet the requirements for flexural strength, chemical solubility, coefficient of thermal expansion, and radioactivity. Both CELTRA Press and predicate IPS e.max Press and IPS e.max Press Multi (K120134) meet the requirements of the applicable Class, as detailed in Table under Technological The performance of CELTRA Press meets the requirements of the non-clinical Characteristics. bench testing conducted to support substantial equivalence.

Toxicological Testing;

Testing according to ISO 10993-1, 10993-5 and 10993-18 (Biological evaluation of medical devices) was completed to characterize the biocompatibility of CELTRA Press. Results of the testing conducted in accordance with ISO standard support the biocompatibility of CELTRA Press. CELTRA Press veneering porcelains (accessory) were compared to reference device, Quattro Porcelain System (K091706) for biocompatibility purposes.

Clinical Performance Data.

Not applicable. No data from human clinical studies has been included to support the substantial equivalence of the CELTRA Press.

Conclusion Regarding Substantial Equivalence

CELTRA Press supports substantial equivalence to the predicate IPS e.max Press and IPS e.max Press Multi cleared under premarket notification K120134 because:

It has the similar intended use as the predicate ●
. Has similar technological characteristics as the predicate, with the exception of flexural strength. CELTRA Press meets the requirement of flexural strength for Type II, Class 4 materials.

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.