•Inlays, onlays, partial crowns
·Crowns in the anterior and posterior areas
·3-unit anterior bridges up to the second premolar
·Single tooth restorations as implant suprastructures for anterior and posterior teeth
·3-unit bridges as implant suprastructures up to the second premolar
· Single tooth mesostructures in the anterior and posterior areas
· Abutment crowns in the anterior and posterior areas

Device Description

VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.

VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets.

AI/ML Overview

This document is a 510(k) summary for VITA Ambria®, a dental material, and does not contain information about an AI/ML device. Therefore, it does not include the specific details you requested regarding acceptance criteria, study sizes, expert qualifications, or MRMC studies for an AI/ML product.

However, I can extract the information relevant to the device's performance given the available text:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Complies to DIN EN ISO 6872: Dentistry - Ceramic Materials	VITA Ambria® meets the applicable requirements of this standard.
Complies to ISO 10993-1: Biological evaluation of medical devices	VITA Ambria® complies with this standard.
Complies to ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices	VITA Ambria® complies with this standard.
Substantially equivalent in performance to VITA PM9 (K050362)	Bench test results allowed the conclusion of substantial equivalence.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document as it refers to non-clinical performance testing of a dental material, not an AI/ML device. The "bench test results" are mentioned, but no specifics on sample sizes for these tests are given. The manufacturer is VITA Zahnfabrik H.Rauter GmbH Co. from Bad Sackingen, Germany.
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 applicable and not provided. The ground truth for biocompatibility and material standards compliance is based on standardized testing procedures, not expert consensus on diagnostic images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided.
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:
- No MRMC study was performed or is applicable, as this is a dental material, not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was performed or is applicable, as this is a dental material.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is compliance with recognized international standards for ceramic dental materials (DIN EN ISO 6872) and biocompatibility (ISO 10993-1, ISO 7405), established through laboratory bench testing.
The sample size for the training set:
- This information is not applicable and not provided, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- This information is not applicable and not provided.

In summary, the provided document is a 510(k) clearance for a dental material (VITA Ambria® zirconia-reinforced lithium silicate press pellets) and not for an AI/ML-driven device. Therefore, the detailed criteria for AI/ML performance are not present. The device's acceptance is based on its compliance with established material and biocompatibility standards and comparison to a predicate device via non-clinical (bench) performance testing.

Summary

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May 14, 2020

VITA Zahnfabrik GmbH H Rauter & Co % Lindsay Tilton Regulatory Affairs Consultant VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887

Re: K193436

Trade/Device Name: VITA Ambria® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 10, 2020 Received: February 14, 2020

Dear Lindsay Tilton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193436

Device Name VITA Ambria®

Indications for Use (Describe)

VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique.

Indications

•Occlusal veneers (table tops), veneers

•Inlays, onlays, partial crowns
·Crowns in the anterior and posterior areas
·3-unit anterior bridges up to the second premolar
·Single tooth restorations as implant suprastructures for anterior and posterior teeth
·3-unit bridges as implant suprastructures up to the second premolar
· Single tooth mesostructures in the anterior and posterior areas
· Abutment crowns in the anterior and posterior areas

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

Submitter	VITA Zahnfabrik H.Rauter GmbH Co.Spitelgasse 3Bad Sackingen, D-79713GermanyEstablishment Reg. No. 1000625496
Contact	Bernd WalkerHead of Regulatory Affairs and Quality SystemsPhone (+49) 7761 562-361Fax (+49) 7761 562-384B.Walker@vita-zahnfabrik.com
Official Correspondent	Lindsay TiltonRegulatory Affairs & Compliance ConsultantVITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (925)699-9091Fax (714) 221-6759E-mail: Itilton@vitanorthamerica.com
Date Prepared	May 11, 2020

" Trade/Device Name Vita Ambria®
" Classification Name Porcelain powder for clinical use
י Regulation Number 21 CFR 872.6660
י Product Code EIH

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Predicate Devices

VITA PM7; PM9 - K050362 – Primary Predicate Device

Device Description

VITA Ambria® VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.

VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets. Below are all the available shades:

LAM030S0365	VITA AMBRIA®, A1-T, S, 5 pcs.
LAM030S0375	VITA AMBRIA®, A2-T, S, 5 pcs.
LAM030S0385	VITA AMBRIA®, A3-T, S, 5 pcs.
LAM030S0415	VITA AMBRIA®, B1-T, S, 5 pcs.
LAM030S0425	VITA AMBRIA®, B2-T, S, 5 pcs.
LAM030S0465	VITA AMBRIA®, C2-T, S, 5 pcs.
LAM030S0495	VITA AMBRIA®, D2-T, S, 5 pcs.
LAM040S0365	VITA AMBRIA®, A1-HT, S, 5 pcs.
LAM040S0375	VITA AMBRIA®, A2-HT, S, 5 pcs.
LAM040S0385	VITA AMBRIA®, A3-HT, S, 5 pcs.
LAM040S0415	VITA AMBRIA®, B1-HT, S, 5 pcs.
LAM040S0425	VITA AMBRIA®, B2-HT, S, 5 pcs.
LAM040S0465	VITA AMBRIA®, C2-HT, S, 5 pcs.
LAM040S0495	VITA AMBRIA®, D2-HT, S, 5 pcs.
LAM030L0363	VITA AMBRIA®, A1-T, L, 3 pcs.
LAM030L0373	VITA AMBRIA®, A2-T, L, 3 pcs.
LAM030L0383	VITA AMBRIA®, A3-T, L, 3 pcs.
LAM030L0413	VITA AMBRIA®, B1-T, L, 3 pcs.
LAM030L0423	VITA AMBRIA®, B2-T, L, 3 pcs.
LAM030L0463	VITA AMBRIA®, C2-T, L, 3 pcs.
LAM030L0493	VITA AMBRIA®, D2-T, L, 3 pcs.
LAM040L0363	VITA AMBRIA®, A1-HT, L, 3 pcs.
LAM040L0373	VITA AMBRIA®, A2-HT, L, 3 pcs.
LAM040L0383	VITA AMBRIA®, A3-HT, L, 3 pcs.
LAM040L0413	VITA AMBRIA®, B1-HT, L, 3 pcs.
LAM040L0423	VITA AMBRIA®, B2-HT, L, 3 pcs.
LAM040L0463	VITA AMBRIA®, C2-HT, L, 3 pcs.
LAM040L0493	VITA AMBRIA®, D2-HT, L, 3 pcs.
LAM030S0025	VITA AMBRIA®, 0M1-T, S, 5 pcs.
LAM030S0045	VITA AMBRIA®, 0M3-T, S, 5 pcs.
LAM040S0025	VITA AMBRIA®, 0M1-HT, S, 5 pcs.
LAM040S0045	VITA AMBRIA®, 0M3-HT, S, 5 pcs.
LAM030L0023	VITA AMBRIA®, OM1-T, L, 3 pcs.
LAM030L0043	VITA AMBRIA®, OM3-T, L, 3 pcs.
LAM040L0023	VITA AMBRIA®, OM1-HT, L, 3 pcs.
LAM040L0043	VITA AMBRIA®, OM3-HT, L, 3 pcs.
LAMSKC	VITA AMBRIA® STARTER KIT VITA classical A1-D4°

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Statement of Intended Use

VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.

Indications

•Occlusal veneers (table tops), veneers
•Inlays, onlays, partial crowns
•Crowns in the anterior and posterior areas
· 3-unit anterior bridges up to the second premolar
Single tooth restorations as implant suprastructures for anterior and posterior teeth
•3-unit bridges as implant suprastructures up to the second premolar
•Single tooth mesostructures in the anterior and posterior areas
· Abutment crowns in the anterior and posterior areas

Technological Characteristics

VITA Ambria contains the above components in an insoluble glass matrix similar to VITA PM9 that is used to fabricate restorations in the press technique.

Non-Clinical Performance Testing

VITA Ambria® meets the applicable requirements of the following FDA recognized standards:

DIN EN ISO 6872 2015 - Dentistry - Ceramic Materials
트 ISO 10993-1:2009 - Biological evaluation of medical devices
ISO 7405:2004 – Dentistry – Evaluation of biocompatibility of medical devices

Bench test results allowed us to conclude that VITA Ambria® is substantially equivalent to the predicate device for its intended use.

Biocompatibility

A biocompatibility assessment was performed on VITA Ambria® in accordance with ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing

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within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. This assessment supports that VITA Ambria® is biocompatible and concludes that the device is safe for its intended use.

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Ambria®.

	Subject Device	Primary PredicateDevice
Device Name	VITA Ambria® AC	VITA PM
Device Classification	Porcelain PowderFor Clinical Use	Porcelain PowderFor Clinical Use
Product Code	EIH	EIH
Regulation Number	21 CFR 872.6660	21 CFR 872.6660
Indication for use	• Occlusal veneers(table tops), veneers• Inlays, onlays, partialcrowns• Crowns in theanterior and posteriorareas• 3-unit anteriorbridges up to thesecond premolar• Single toothrestorations asimplantsuprastructures foranterior and posteriorteeth• Single toothmesostructures in theanterior and posteriorareas• Abutment crowns inthe anterior andposterior areas	o Single and multi-surface inlayso Onlayso Veneerso Partial crownso Anterior crowns oPremolar crownsAlso for oxide-ceramiccrown and bridgesubstructures to beveneered withconventionalporcelain.

Table Comparison to Predicate Devices

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Components	Lithium silicate	Lithium silicate
Technology comparison	Pellets in various shades	Pellets in various shades
Sterile	Non Sterile	Non Sterile
Principle of operation	for the fabrication of restorations in the press technique	for the fabrication of restorations in the press technique
Performance Testing	Complies to ISO 6872	Complies to ISO 6872
Biocompatibility Testing	Complies to ISO 10993-1	Complies to ISO 10993-1

The indications for use are more detailed for the Ambria device, but cover the same indications for the predicate. The indication of the predicate is comparable to that of the new device, even if it is written in a very general way. The subject device lists out all the different substrates it can be used with, while the predicate leaves the terms more general. Both cover the same indications and no additional indications are added to the subject device, therefore this does not affect the substantial equivalence.

Conclusion

Information provided in this application demonstrates that VITA Ambria® is substantially equivalent to the legally marketed predicate device.

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.