Tetric® CAD is a composite block for the fabrication of esthetic permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).

Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tetric® CAD device:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device's performance against specific clinical benchmarks. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not directly available in this type of submission. Instead, the focus is on showing similarity in functional performance and safety compared to an already approved device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the new device (Tetric® CAD) performs comparably or better than the predicate device (Cerasmart K133824) for the listed physical properties. The data presented are for comparison.

Performance Metric	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Tetric® CAD)	Reported Predicate Performance (Cerasmart K133824)
Material Properties
Flexural Strength	Comparable to predicate's 238 MPa	Typical mean value: 272 MPa	Brochure: 238 MPa
Water Solubility	According to ISO 10477:2004	Tested	Not explicitly stated (implied to meet standard)
Biocompatibility
Cytotoxicity	Non-cytotoxic (according to EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009)	Non-cytotoxic	Evaluated according to ISO 10993-1:2009
Genotoxicity	Non-genotoxic (according to ISO 10993-3:2014)	Non-genotoxic	Not explicitly stated (implied to meet standard)
Shelf Life		36 months	5 years
Storage Conditions		2 - 28 °C / 36 - 82 °F, avoid sunlight	4 - 25 °C / 39.2 - 77.0 °F, away from direct sunlight and high humidity

Note on Acceptance Criteria: For a 510(k), "acceptance criteria" mainly revolve around demonstrating the new device is as safe and effective as the predicate. For physical properties, this usually means meeting or exceeding the predicate's performance when tested under relevant standards. The document explicitly states "the results of the bench testing show the products to be substantially equivalent," meaning the Tetric® CAD met the implicit acceptance criterion of being comparable.

The subsequent points (2-9) are largely not applicable or not explicitly detailed in the provided 510(k) summary because this document focuses on bench testing and biocompatibility for material properties and substantial equivalence, rather than clinical efficacy studies with human subjects.

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: Not explicitly stated for specific tests like flexural strength or water solubility in the summary. For ISO standard compliance (like ISO 10477 and ISO 6872), specific sample sizes are prescribed by the standards, but these aren't given in this summary.
Data provenance: Not specified in the summary. This would typically be from the manufacturer's R&D labs.
Retrospective or prospective: Not applicable for bench (non-clinical) testing.

The following points (3-6) are typically relevant for clinical studies, which are not detailed in this 510(k) summary for Tetric® CAD, as the focus is on material properties and substantial equivalence through bench 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 pertains to clinical studies often involving expert review of images or patient outcomes. The provided document details bench testing of material properties and biocompatibility, which does not involve establishing ground truth by human experts in this manner.

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

Not Applicable. This is for clinical studies with human assessors.

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 type of study is typically for diagnostic AI devices, not for dental restorative materials like Tetric® CAD.

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

Not Applicable. This refers to AI algorithm performance.

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

For Flexural Strength and Water Solubility: The "ground truth" is established by the standardized measurement methods defined in ISO 6872:2015 and ISO 10477:2004, respectively.
For Biocompatibility: The "ground truth" is determined by the results of specific in-vitro tests for cytotoxicity (EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009) and genotoxicity (ISO 10993-3:2014), following the principles of ISO 10993-1:2009 + AC:2010.

8. The sample size for the training set

Not Applicable. This is relevant for AI models. The document describes a material and its testing, not an AI system.

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

Not Applicable. This is relevant for AI models.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Ivoclar Vivadent AG % Donna Hartnett Director QA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228

Re: K173573

Trade/Device Name: Tetric® CAD Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: May 3, 2018 Received: May 8, 2018

Dear Donna Hartnett:

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 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);

June7, 2018

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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 medical devices and radiation-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.

Mary S. Runner -S

forTina 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) K173573

Device Name Tetric® CAD

Indications for Use (Describe)

Tetric® CAD is intended for:

Veneers
Inalys
Onlays (e.g. occlusal veneers, partial crowns)
Crowns in the anterior and posterior region

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Image /page/3/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in green and "Vivadent" in blue. The tagline "passion vision innovation" is written in a smaller font below the company name. The logo also includes a series of green and blue dots and squares arranged in an arc above and to the right of the company name.

Contact:	Donna Hartnett, Director QA/RegulatoryIvoclar Vivadent, Inc.175 Pineview DriveAmherst, New York 14228716-691-2260Donna.hartnett@ivoclarvivadent.com
Company:	Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535
Date Prepared:	June 5, 2018
Proprietary Name:	Tetric® CAD
Classification Name:	Material, Tooth Shade, Resin (872.3690)(Product Code: EBF)
Predicate Device:	Cerasmart (K133824) by GC America, Inc.

Tetric® CAD is a composite block for the fabrication of esthetic Device Description: permanent inlays, onlays, veneers and crowns in the anterior and posterior region. Fabrication of the dental restoration is performed at the dentist's office in a compatible milling machine. The blocks are composed of cross-linked dimethacrylate and inorganic fillers. In the processing technique, the restoration is polished and seated after milling in the CAD/CAM system. The blocks are attached to a metal mandrel, the geometry of such is compatible with a milling machine, e.g. Cerec/InLab (Sirona), PlanMill (PlanMeca) or Programill One (Ivoclar Vivadent).

Tetric® CAD composite blocks are available in the translucency levels MT (5 shades - A1, A2, A3, A3.5, BL) and HT (4 shades 0 A1, A2, A3, A3.5), and in the sizes I12 and C14.

Indications for Use:

Tetric® CAD is intended for:

Veneers "
-Inalys
-Onlays (e.g. occlusal veneers, partial crowns)
Crowns in the anterior and posterior region -

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K173573

Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and green, with the words "Ivoclar" and "Vivadent" stacked on top of each other. Above the words are a series of green dots and squares. The logo is simple and modern, and it is likely used to represent the company's brand.

510(K) SUMMARY

Comparison to Predicate: The primary predicate devices to which Tetric® CAD has been compared is GC Americ a's Cerasmart (K133824).

Device	GC America: Cerasmart (K133824)	Ivoclar Vivadent: Tetric® CAD (K173573)
Indications for Use	The product is indicated for inlays, onlays,veneers and full crown restorations,including crowns on implants.	Tetric® CAD is intended for:- Veneers- Inlays- Onlays (e.g. occlusalveneers, partial crowns)- Crowns in the anterior andposterior region
Precaution Measures/Contraindications/Processing restrictions/Side effects	In rare cases this product may causesensitivity insome people. If such reactions areexperienced, discontinuethe use of product and consult a physician.Personal protective equipment such asgloves, facemasks and safety eyewear should always beworn.	Contraindications:- Bridge constructions- Conventional and self-adhesivecementation- Temporary cementation- Patients with severely reduced residualdentition- Any other use not listed in the indicationsFailure to observe the following restrictionsmay compromisethe results achieved with Tetric® CAD:- Falling short of the required minimumlayerthicknesses- Milling the blocks in a non-compatibleCAD/CAM system- Deviations from the recommended lutingprotocolIf a patient is known to be allergic to any ofthe ingredients of Tetric® CAD, the materialshould not be used.Do not inhale the composite resin dustduring finishing.Use suction equipment and wear a dustmask
Summary ofIndications, PrecautionMeasures/Contraindications/Processing restrictions/Side effects	The precautions, processing restrictions and contraindications are described in more detailfor Tetric® CAD, but in total the indications and contraindications are substantiallyequivalent.
Technology	Cerasmart is a pre-cured composite blockfor milling CAD/CAM indirect restorations.The milled device is used for therestorations of both anterior and posteriorteeth.	Tetric® CAD is a composite block for thefabrication of permanent inlays, onlays,veneers and crowns in the anterior andposterior region.In this processing technique, therestoration is polished and incorporatedimmediately after milling in the CAD/CAMsystem.
Summary of TechnologyDelivery forms/dosage	The devices are similar, there is a minor difference in the wording.The blocks are available in 3 sizes (12, 14,14L) in 33 shades (Translucency HT, LT andone Bleach shade).	The blocks are available in thetranslucency levels MT and HT, in 5 and 4shades respectively, and in the sizes I12and C14.
Summary of Deliveryforms/dosage	The predicate device is available in 3 sizes, one more than Tetric® CAD (14L is notavailable for Tetric® CAD). Additionally the predicate device offers 33 shades(Translucency HT, LT and a Bleach shade), Tetric® CAD offers 5 shades for MT and 4shades for HT. Even though less shades are available the dentist can still meet theaesthetic demands of the patient.
Storage Conditions	Storage at room temperature (4 - 25 $^{\circ}$ C/39.2 -77.0 $^{\circ}$ F), away from direct sunlight andhigh humidity;Shelf life: 5 years from date of manufacture	Storage conditions: 2 - 28 $^{\circ}$ C/36 - 82 $^{\circ}$ F,avoid sunlightShelf life: 36 months
Summary of StorageConditions	The recommended shelf life is shorter for the new product, as less data is currentlyavailable.
Principles of Operation	Step by Step:-Preparation Design, shade selection-Scanning and Milling-Finishing and polishing-Characterization-Pre-Treatment-Cementation-Maintenance and repair	Step by Step:- Preparation, shade determination- Intraoral imaging, CAD/CAM process- Polishing- Characterization- Preparing for cementation- Cementation- Checking the articulation/occlusion,polishing- Aftercare
Summary Principles ofoperation	There are minor differences in the wording between the predicate and the new productTetric® CAD, but these are not significant and the principle of the operation is substantiallyequivalent.
Summary ChemicalComposition	Both products are pre-cured composite blocks with differences in composition. Tetric® CADhas evaluated biocompatibility according to ISO 10993- 1:2009.
Finished DeviceSpecification	Applicable standard: No informationApplicable FDA Guidance: No information	EN 1641:2009 – Dentistry - Medicaldevices for dentistry -MaterialsDental Composite Resin Devices –Premarket Notification[510(k)] Submission
Sensitivity to light	Not relevant - industrially cured	Not relevant - industrially cured
Color stability	Not relevant - industrially cured	Not relevant - industrially cured
FlexuralStrength	Brochure: 238 MPa	Typical mean value (IFU): 272 MPa
Sterilization	Not applicable. No sterilizationrecommendation.	Not applicable. No sterilizationrecommendation.
Single use	Consumable material	Consumable material
Summary of FinishedDevice Specification	Tetric® CAD fulfils the relevant standard and follows the relevant Guidance.
Summary ofPerformanceSpecification	The value for flexural strength of Cerasmart (GC`s brochure) correlates with IvoclarVivadent's Tetric® CAD.

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510(K) SUMMARY

Image /page/5/Picture/2 description: The image shows the logo for Ivoclar Vivadent. The logo is in two lines, with "ivoclar" on the first line and "vivadent" on the second line. The word "ivoclar" is in green, and the word "vivadent" is in blue. There is a series of green and blue dots above the word "ivoclar".

Substantial equivalence to the predicate:

The subject and the predicate device are pre-cured composite blocks for milling CAD/CAM restorations. Thus, the devices have the same function, have similar principles of operation and a similar chemical composition. The forgoing comparison supports that the subject device is substantially equivalent to the predicate device.

Differences :

The recommended storage temperature is marginally different (2-28 °C) compared to 4-25 °C for the predicate device. This is not substantial and is due to company policy. The shelf life is shorter (36 months) compared to 5 years for the predicate device. This is not substantial and is due to ongoing real-time testing.

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510(K) SUMMARY

Image /page/6/Picture/2 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "Ivoclar" in a darker blue and "Vivadent" in a lighter blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the slogan "passion vision innovation" in a smaller font.

The chemical composition is not fully published for the predicate device and therefore it is assumed there is some difference in ingredients, although the published data shows both products to be substantially equivalent.

Non-clinical performance testing:

Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: water solubility according to ISO 10477:2004 and flexural strength according to ISO 6872:2015. The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent.

Biocompatibility:

The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009 +AC:2010. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013; ISO 10993-5:2009 and Genotoxicity according to 10993-3:2014 and the device was found to be non-cytotoxic and non-genotoxic.

Conclusion: The data show that Tetric® CAD is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.