VITA VM LC Flow

K152373 · Vita Zahnfabrik H.Rauter GmbH & Co. · EBF · Dec 30, 2015 · Dental

Device Facts

• Record ID: K152373
• Device Name: VITA VM LC Flow
• Applicant: Vita Zahnfabrik H.Rauter GmbH & Co.
• Product Code: EBF · Dental
• Decision Date: Dec 30, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

VITA VM LC Flow is a light-cured microparticle indirect composite material; used for extraoral fabrication of fixed and removable dental restorations. Material consists of dimethacrylate resin mixture and filler particles. Fabricated by dental technicians in a laboratory setting; applied to frameworks or used for temporary restorations. Polymerization achieved via external light or UV radiation source. Output is a hardened, tooth-shaded dental restoration. Benefits include aesthetic restoration of dental structures and provision of long-term temporary solutions.

Clinical Evidence

Bench testing only. Compliance with ISO 10477:2004(E) demonstrated through physical property testing including flexural strength (135 MPa), E-modulus (6600-7500 MPa), water absorption (25.4 µg/mm³), and water solubility (0.1 µg/mm³). Biocompatibility assessment performed per ISO 10993-1:2009 and ISO 7405:2008; no clinical data provided.

Technological Characteristics

Type 2, Class 2 polymer-based crown and bridge material per ISO 10477:2004(E). Composition: dimethacrylate resins, inorganic fillers, pigments, and light/UV-sensitive initiators. Physical form: paste. Energy source: external light or UV radiation for polymerization. Biocompatibility assessed per ISO 10993-1 and ISO 7405.

Indications for Use

Indicated for dental patients requiring full/partial veneering of metal frameworks (crowns, bridges, telescopic crowns, implant superstructures), individualization/layering of VITA ENAMIC or acrylic teeth, layering over long-term temporaries (VITA CAD-Temp), reproduction of gingival components, metal-free crowns/three-unit anterior bridges as long-term temporaries, veneering of removable dentures, inlays, and veneers.

Regulatory Classification

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.

Predicate Devices

• VITA Zeta (K961434)

Reference Devices

• SR Nexco (K123304)
• SINFONY (K992645)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>Spitelgasse 3<br>Bad Sackingen, D-79713<br>Germany<br>Establishment Reg. No. 1000625496 | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact | Bernd Walker<br>Head of Regulatory Affairs and Quality Systems<br>Phone [phone]<br>Fax [phone] | | |
| Official Correspondent | Nevine Erian<br>Director, Regulatory Affairs & Compliance (Consultant)<br>VITA North America, Inc.<br>22705 Savi Ranch Parkway, Suite 100<br>Yorba Linda, CA 92887<br>Establishment Reg. No. 2082832<br>Phone [phone]<br>Fax [phone]<br>E-mail: [e-mail] | | |
| 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 LC<br>Flow | VITA Zeta<br>(Primary<br>Predicate) | SR Nexco<br>(Reference<br>Predicate) | SINFONY<br>(Reference<br>Predicate) |
|--------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------|--------------------------------------|-------------------------------------|
| Indications for Use | | | | |
| Full & Partial veneering of<br>metal frameworks: crowns,<br>bridges, telescopic crowns,<br>implant superstructures | Yes | Yes | Yes | Yes |
| Veneering of acrylic resin<br>frameworks | Yes | Yes | Yes | Yes |
| Layering-over long-term<br>temporaries | Yes | Yes | Yes | Yes |
| Individualization of acrylic<br>teeth | Yes | Yes | Yes | Yes |
| Metal-free crowns & three-<br>unit anterior bridges as<br>long-term temporary<br>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 &<br>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,<br>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<br>MPa | 3450 MPa | $6500 \u00b1 500$<br>MPa | 3100 MPa | |
| Water Absorption | 25.4 µg/mm³ | 28 - 30<br>µg/mm³ | $15 \u00b1 1$ µg/mm³ | $\approx 20$<br>µg/mm³ | |
| Water Solubility | 0.1 µg/mm³ | 0 µg/mm³ | $1 \u00b1 0.5$<br>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.