Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
Individualization of and layering on VITA ENAMIC®
Layering-over long-term temporaries made from VITA CAD-Temp®
Individualization of acrylic teeth
Reproduction of gingival components
Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
Veneering of removable and partially removable dentures (according to the manufacturer's information)
Inlays
Veneers

Device Description

VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.

AI/ML Overview

This document describes the VITA VM® LC Flow, a dental veneering material. It does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device testing (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance:

The primary acceptance criteria mentioned are adherence to the FDA recognized standard, ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials. The device's performance is compared against this standard and predicate devices.

Acceptance Criteria (from ISO 10477:2004(E))	Reported Device Performance (VITA VM® LC Flow)	Comparison with Predicate Devices (Examples)
ISO 10477 – Physical Property requirements	All Pass	All predicate devices also pass
Specific Physical Properties (bench testing):
Flexural Strength	135 MPa	VITA Zeta: 95 MPa, SR Nexco: 90 ± 10 MPa, SINFONY: 105 MPa (VITA VM® LC Flow meets or exceeds all listed predicates)
E-Modulus	6600 - 7500 MPa	VITA Zeta: 3450 MPa, SR Nexco: 6500 ± 500 MPa, SINFONY: 3100 MPa (VITA VM® LC Flow is comparable or higher than listed predicates)
Water Absorption	25.4 µg/mm³	VITA Zeta: 28 - 30 µg/mm³, SR Nexco: 15 ± 1 µg/mm³, SINFONY: ≈ 20 µg/mm³ (VITA VM® LC Flow is within the range of performance of listed predicates)
Water Solubility	0.1 µg/mm³	VITA Zeta: 0 µg/mm³, SR Nexco: 1 ± 0.5 µg/mm³, SINFONY: 0.5 µg/mm³ (VITA VM® LC Flow is comparable to listed predicates)
Biocompatibility	VITA VM® LC Flow is biocompatible per assessment based on ISO 10933-1:2009 and ISO 7405:2008.	All predicate devices are assumed to meet similar biocompatibility requirements for substantial equivalence.

Study Information:

Sample size used for the test set and the data provenance: Not explicitly stated for each specific test, but the testing was "bench testing" performed in accordance with ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials standard. The country of origin for the data is not specified, but the submitter is based in Germany. The data is retrospective as it refers to performance data from tests conducted prior to the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device relying on expert interpretation of results. The "ground truth" for the physical property tests is based on the methods described in the ISO standard.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the device's performance validation is based on the physical and chemical property testing methodologies outlined in the ISO 10477:2004(E) and related biocompatibility standards (ISO 10933-1:2009, ISO 7405:2008). These are objective measurements rather than expert consensus or patient outcomes.
The sample size for the training set: Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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

December 30, 2015

Vita Zahnfabrik H. Rauter Gmbh & Co. c/o Ms. Nevine Erian Director, Regulatory Affairs & Compliance Vita North America, Inc. 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887

Re: K152373

Trade/Device Name: VITA VM® LC Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 1, 2015 Received: December 2, 2015

Dear Ms. Erian:

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 (reporting of medical devicerelated 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/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 yours,

Tina Kiang -S

for Erin I. Keith, M.S. 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): K152373

Device Name: VITA VM®LC Flow

Indications for Use:

그 Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
그 Individualization of and layering on VITA ENAMIC®
Layering-over long-term temporaries made from VITA CAD-Temp®
트 Individualization of acrylic teeth
Reproduction of gingival components
트 Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
Veneering of removable and partially removable dentures (according to the manufacturer's information)
Inlays
. Veneers

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sian Off) Division of Dental, Infection Control and General Hospital Devices

510(k) Number

Prescription Use (Par. 21 CFR 801.109) OR

Over-The-Counter Use

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Section 5 – 510(k) Summary – K152373

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) 7761/562-384
Official Correspondent	Nevine ErianDirector, Regulatory Affairs & Compliance (Consultant)VITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (949) 370-7155Fax (714) 221-6759E-mail: nerian@vident.com
Date Prepared	December 29, 2015
Trade/Device Name	VITA VM® LC Flow
Common Name	Dental Veneering Material
Classification Name	Tooth Shade Resin Material
Regulation Number	21 CFR 872.3690
Product Code	EBF

Predicate Devices

VITA Zeta® (VITA Zahnfabrik GmbH) – K961434 – Primary Predicate SR Nexco® (Ivoclar Vivadent, AG) – K123304 – Reference Predicate SINFONY® (ESPE Dental, AG) – K992645 – Reference Predicate

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Device Description

VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.

Statement of Intended Use

Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
트 Individualization of and layering on VITA ENAMIC®
Layering-over long-term temporaries made from VITA CAD-Temp®
트 Individualization of acrylic teeth
Reproduction of gingival components
트 Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
. Veneering of removable and partially removable dentures (according to the manufacturer's information)
Inlays
트 Veneers

Material Composition

VITA VM LC Flow pastes consist of a mixture of dimethacrylates and filler particles.

Technological Characteristics

VITA VM LC Flow is classified as Type 2, Class 2, Polymer-based crown and bridge materials whose setting is effected by the application of energy from an external source, such as heat and/or light or UV radiation, Polymer-based crown and bridge materials that contain a light or UV-sensitive initiator , per ISO 10477:2004(E) - Dentistry -Polymer-based crown and bridge materials standard.

Biocompatibility

A biocompatibility assessment was performed on VITA VM LC Flow, in accordance with ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. Based on the assessment, biocompatibility testing was determined not necessary. This assessment supports that

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VITA VM LC Flow is biocompatible.

Substantial Equivalence

VITA VM LC Flow shares the same intended use as the predicate devices. VITA VM LC Flow is comprised of same materials as the predicate devices. VITA VM LC Flow shares similar indications, chemical composition, technological characteristics and physical properties as the predicate devices. Any differences between VITA VM LC Flow and its predicates do not affect substantial equivalence as VITA VM LC Flow meets same biocompatibility requirements and ISO 10477 physical property requirements as the predicate devices.

Information provided in this application demonstrates that VITA VM LC Flow is substantially equivalent to the predicate devices.

	VITA VM LCFlow	VITA Zeta(PrimaryPredicate)	SR Nexco(ReferencePredicate)	SINFONY(ReferencePredicate)
Indications for Use
Full & Partial veneering ofmetal frameworks: crowns,bridges, telescopic crowns,implant superstructures	Yes	Yes	Yes	Yes
Veneering of acrylic resinframeworks	Yes	Yes	Yes	Yes
Layering-over long-termtemporaries	Yes	Yes	Yes	Yes
Individualization of acrylicteeth	Yes	Yes	Yes	Yes
Metal-free crowns & three-unit anterior bridges aslong-term temporaryrestorations	Yes	Yes	Yes	Yes
Inlays	Yes	Yes	Yes	Yes
Onlays	No	Yes	Yes	Yes
Veneers	Yes	Yes	Yes	Yes
Technological Aspect
Light-Cured Material	Yes	Yes	Yes	Yes
Physical Configuration	Paste	Paste &Powder	Paste	Paste

Technical Comparison of VITA VM LC Flow to Predicate Devices

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Material Composition	All are made of Methacrylate resins, photo-initiators,inorganic fillers and pigments
ISO 10477 – Physical Property	All Pass
Flexural Strength	135 MPa	95 MPa	$90 \u00b1 10$ MPa	105 MPa
E-Modulus	6600 - 7500MPa	3450 MPa	$6500 \u00b1 500$MPa	3100 MPa
Water Absorption	25.4 µg/mm³	28 - 30µg/mm³	$15 \u00b1 1$ µg/mm³	$\approx 20$µg/mm³
Water Solubility	0.1 µg/mm³	0 µg/mm³	$1 \u00b1 0.5$µg/mm³	0.5 µg/mm³

Non-Clinical Performance Testing

Bench testing was performed in accordance with FDA recognized standard, ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials standard. VITA VM LC Flow meets applicable ISO 10477 criteria for the designated indications.

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA VM LC Flow.

Conclusion

Non-clinical performance testing of VITA VM LC Flow demonstrates that VITA VM LC Flow is as safe and effective for its intended use, and performs as well as the legally marketed predicate devices.

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.