(131 days)
No
The 510(k) summary describes a light-cured composite material and its intended uses in dental restorations. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on material properties like flexural strength and water absorption, not algorithmic performance.
No
This device is a dental composite material used for fabricating restorations and prosthetics, not for treating diseases or conditions.
No
This device is a light-cured composite material used for fabricating and repairing dental restorations (crowns, bridges, veneers, etc.), not for diagnosing medical conditions. It is a material used in the treatment/restoration process.
No
The device description clearly states it is a "light-cured microparticle indirect composite material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the fabrication and restoration of dental prosthetics (crowns, bridges, veneers, dentures, etc.). These are materials used in the mouth or on dental structures, not for testing biological samples in vitro (outside the body).
- Device Description: The description clearly states it's a "light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication." This describes a dental material, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely restorative and structural in a dental context.
N/A
Intended Use / Indications for Use
- 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
Product codes
EBF
Device Description
VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Flexural Strength: 135 MPa
E-Modulus: 6600 - 7500 MPa
Water Absorption: 25.4 µg/mm³
Water Solubility: 0.1 µg/mm³
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
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.
1
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 3
Bad Sackingen, D-79713
Germany
Establishment Reg. No. 1000625496 | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact | Bernd Walker
Head of Regulatory Affairs and Quality Systems
Phone (+49) 7761/562-361
Fax (+49) 7761/562-384 | | |
| Official Correspondent | Nevine Erian
Director, Regulatory Affairs & Compliance (Consultant)
VITA North America, Inc.
22705 Savi Ranch Parkway, Suite 100
Yorba Linda, CA 92887
Establishment Reg. No. 2082832
Phone (949) 370-7155
Fax (714) 221-6759
E-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
5
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 LC
Flow | VITA Zeta
(Primary
Predicate) | SR Nexco
(Reference
Predicate) | SINFONY
(Reference
Predicate) |
|--------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------|--------------------------------------|-------------------------------------|
| Indications for Use | | | | |
| Full & Partial veneering of
metal frameworks: crowns,
bridges, telescopic crowns,
implant superstructures | Yes | Yes | Yes | Yes |
| Veneering of acrylic resin
frameworks | Yes | Yes | Yes | Yes |
| Layering-over long-term
temporaries | Yes | Yes | Yes | Yes |
| Individualization of acrylic
teeth | Yes | Yes | Yes | Yes |
| Metal-free crowns & three-
unit anterior bridges as
long-term temporary
restorations | 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
6
| 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 - 7500
MPa | 3450 MPa | $6500 \u00b1 500$
MPa | 3100 MPa | |
| Water Absorption | 25.4 µg/mm³ | 28 - 30
µg/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.