The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.

TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.

TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.

Device Description

Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges

The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.

The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.

The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for dental polymer blanks. This type of document is for demonstrating substantial equivalence to a predicate device, not for describing the acceptance criteria and study proving a device meets them for a novel AI/software product. Therefore, much of the requested information regarding AI/software performance studies is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the performance relative to a standard for the physical properties of these dental devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject devices are based on their compliance with the International Standard ISO 10477:2004 for polymer-based dental restorative materials. The reported device performance is presented as the measured values for flexural strength, water absorption, and water solubility.

Property	Acceptance Criteria (based on ISO 10477:2004)	Reported Device Performance (Subject Devices)	Reported Device Performance (Predicate Device: IDODENTINE)	Comparison
Flexural Strength	Must correspond with the requirements of the standard (specific numerical requirement not explicitly stated but implied by "Similar" comparison to predicate).	TEMP BASIC: 64 MPaTEMP PREMIUM: 106 MPaTEMP PREMIUM FLEXIBLE: 110 MPaMULTISTRATUM FLEXIBLE: 120 MPaTHERAPON: 115 MPaTRY-IN: 65.32 MPaBURNOUT: 53.66 MPaTRY-IN & BURNOUT: 57.34 MPa	IDODENTINE MULTILAYER: 83 MPaIDODENTINE TRANSPA: 94 MPa	Similar. The Temp Basic, Try-In, Burnout, and Try-In & Burnout have lower values, but these differences are deemed "not significant" due to their limited usage.
Water Absorption	Must correspond with the requirements of the standard.	TEMP BASIC: 20.46 µg/mm³TEMP PREMIUM: 19.36 µg/mm³TEMP PREMIUM FLEXIBLE: 3.97 µg/mm³MULTISTRATUM FLEXIBLE: 2.90 µg/mm³THERAPON: 14.1 µg/mm³TRY-IN: 20.47 µg/mm³BURNOUT: 20.10 µg/mm³TRY-IN & BURNOUT: 19.68 µg/mm³	IDODENTINE MULTILAYER: 22.3 µg/mm³IDODENTINE TRASPA: 25.8 µg/mm³	Similar
Water Solubility	Must correspond with the requirements of the standard.	TEMP BASIC: 0 µg/mm³TEMP PREMIUM: <1 µg/mm³TEMP PREMIUM FLEXIBLE: 1.98 µg/mm³MULTISTRATUM FLEXIBLE: 0 µg/mm³THERAPON: 0 µg/mm³TRY-IN: 0.69 µg/mm³BURNOUT: 1.00 µg/mm³TRY-IN & BURNOUT: 1.51 µg/mm³	IDODENTINE MULTILAYER: 0.7 µg/mm³IDODENTINE TRANSPARENT: 0.9 µg/mm³	Similar
Biocompatibility	No issue of biocompatibility arises (Implied acceptance criteria for ISO 10993-1 tests).	In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity demonstrated biocompatibility.	N/A (implied acceptable for predicate)	Demonstrated that no issue of biocompatibility arises.

Study Details (based on the provided text):

Sample size used for the test set and the data provenance:
- The document states "All tested samples correspond with the requirements of the standard" for physical properties. It does not specify the exact sample size for each test.
- Data provenance is not explicitly stated as country of origin, but the applicant's address is in Italy. The tests were performed according to international standards (ISO).
- The study is a non-clinical, in-vitro laboratory testing study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical, physical and biocompatibility testing study against ISO standards, not an AI/software performance study requiring expert ground truth for interpretation of images or clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. See point 2.
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 document does not describe a MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes physical and biocompatibility testing of dental materials, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests were the physical and chemical requirements defined by the ISO 10477:2004 standard and the biological evaluation principles of ISO 10993-1.
The sample size for the training set: Not applicable. There is no AI/machine learning model to train.
How the ground truth for the training set was established: Not applicable. There is no AI/machine learning model to train.

Summary

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June 28, 2018

Zirkonzahn GmbH Sandra Leitner Regulatory Affairs Responsible Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, 39030 ITALY

Re: K180562

Trade/Device Name: TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: March 30. 2018 Received: April 3, 2018

Dear Sandra Leitner:

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 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

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) K180562

Device Name

TEMP BASIC, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

Indications for Use (Describe)

TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 05 510(k) Summary

(k) SUMMARY 510

APPLICANT

ZIRKONZAHN GMBH Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com

CONTACT PERSON

Sandra Leitner Regulatory Affairs ZIRKONZAHN GMBH Gewerbegebiet - Zona Industriale an der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 784 Fax: +39 0474 066 661 E-mail: sandra.leitner@zirkonzahn.com

Date Summary Prepared: June 28, 2018

DEVICE IDENTIFICATION

Trade/Proprietary Name:	TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE,MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT,TRY-IN & BURNOUT
Generic/ Common Name:	Dental polymer blanks (discs)
Classification name:	21 CFR 872.3770,CROWN AND BRIDGE, TEMPORARY, RESIN,
Class	II
Product Code:	EBG
Secondary Product Code:	POW
Panel:	Dental

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LEGALLY MARKETED PREDICATE AND REFERENCE DEVICES

	Device Name	Company	510(k) Number
Predicate Device	IDODENTINE	Union Dental S. A.	K150432
Reference Device	Polycarb	Inovativ, LLC	K022030

INDICATIONS FOR USE: The resin discs TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.

TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.

DEVICE DESCRIPTION

Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges

The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.

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DISCUSSION OF NON CLINICAL TESTS

The subject devices were tested according to ISO 10477:2004 to determine their flexural strength, water absorption and water solubility. All tested samples correspond with the requirements of the standard.

In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the subject devices were tested to evaluate: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity. Biocompatibility testing demonstrated that no issue of biocompatibility arises.

The results of nonclinical tests demonstrate that the devices are equivalent to the predicate devices.

SUBSTANTIAL EQUIVALENCE DISCUSSION

The table below provides a more detailed comparison of the submitted devices and the predicate devices.

Both, the submitted devices and the predicates are made of polymers that have a well- documented history for use in medical device applications and have been in use for many years.

The submitted devices and the predicates have similar indications for use as well as comparable technical, physical, chemical and biological properties and characteristics.

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	TEMP BASIC, TEMP PREMIUM, TEMPPREMIUM FLEXIBLE,MULTISTRATUM FLEXIBLE,THERAPON, TRY-IN, BURNOUT,TRY-IN & BURNOUT	Predicate Device:IDODENTINE blanksK150432	Reference Device:POLY-CARBK022030	Comparison
Company	ZIRKONZAHN GMBH	UNION DENTAL S.A.	INOVATIV, LLC
Regulation number	872.3770	872.3770	872.3770	Same
Product Code	EBG	EBG	EBG	Same
Classification name	Temporary crown and bridge resin.	Temporary crown and bridgeresin.	Temporary crown andbridge resin.	Same
Indications for use	The resin discs TEMP PREMIUM, TEMPPREMIUM FLEXIBLE, MULTISTRATUMFLEXIBLE and THERAPON arepolymethylmethacrylate and polycarbonatediscs indicated to manufacture temporaryanterior and posterior crowns and bridges,with up to two adjacent pontics, that can bekept in the mouth for up to 12 months.TEMP BASIC are PMMA discs intended forthe fabrication of temporary anterior crownsand bridges, with up to one adjacent pontic,with a maximum recommended usage timeof 12 months.TRY-IN, BURNOUT and TRY-IN &BURNOUT are PMMA discs intended for the	Temporary anterior andposterior crowns Temporaryanterior and posterior bridgeswith up to two adjacent ponticsImplant supported temporaryrestorations Maximumrecommended usage period: 12monthsRemovable structures fordentures (dental bases)Removable structures fortherapeutic restorations (bitesplints or occlusal splints)	The Polycarb is intendedfor the fabrication oftemporary dentalprostheses like partialdenture clasps, temporarycrowns, and bridges usingthe Inovativ, LLC Polycarbresin.	Similar. The Zirkonzahndevices are more limited intheir indications for use.No new questions of safetyand effectiveness are arisingas the indications are notexpanded, but morerestricted.
	fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
Components	PMMA or PC based resins with approx. 1% pigments	PMMA >99% wt.Pigments <1% wt.	PC based resin	Similar
Intended user	Professional dental technicians	Professional dental technicians	Professional dental technicians	Same
Physical Properties	According to ISO 10477:2004	According to ISO 10477:2004	N/A	Same
Flexural Strength	TEMP BASIC: 64 MPaTEMP PREMIUM: 106 MPaTEMP PREMIUM FLEXIBLE: 110 MPaMULTISTRATUM FLEXIBLE: 120 MPaTHERAPON: 115 MPaTRY-IN: 65.32 MPaBURNOUT: 53.66 MPaTRY-IN & BURNOUT: 57.34 MPa	IDODENTINE MULTILAYER: 83 MPaIDODENTINE TRANSPA: 94 MPa	N/A	SimilarThe Temp Basic, Try-In, Burnout and Try-In & Burnout have lower values. These differences are not significant, due to their limited usage.
Water absorption	TEMP BASIC: 20.46 µg/mm³TEMP PREMIUM: 19.36 µg/mm³TEMP PREMIUM FLEXIBLE: 3.97 µg/mm³MULTISTRATUM FLEXIBLE: 2.90 µg/mm³	IDODENTINE MULTILAYER:22.3 µg/mm³IDODENTINE TRASPA:25.8 µg/mm³	N/A	Similar
	THERAPON: 14.1 µg/mm³TRY-IN: 20.47 µg/mm³BURNOUT: 20.10 µg/mm³TRY-IN & BURNOUT: 19.68 µg/mm³
Water solubility	TEMP BASIC: 0 µg/mm³TEMP PREMIUM: <1 µg/mm³TEMP PREMIUM FLEXIBLE: 1.98 µg/mm³MULTISTRATUM FLEXIBLE: 0 µg/mm³THERAPON: 0 µg/mm³TRY-IN: 0.69 µg/mm³BURNOUT: 1.00 µg/mm³TRY-IN & BURNOUT: 1.51 µg/mm³	IDODENTINE MULTILAYER:0.7 µg/mm³IDODENTINE TRANSPARENT:0.9 µg/mm³	N/A	Similar

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CONCLUSION

Based on the available information, the nevicates are similar in function, composition, production technology and intended use. Therefore, we conclude that the proposed devices are substantially equivalent to the predicates.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.