SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO

K123304 · Ivoclar Vivadent, AG · EBF · Jan 24, 2013 · Dental

Device Facts

• Record ID: K123304
• Device Name: SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
• Applicant: Ivoclar Vivadent, AG
• Product Code: EBF · Dental
• Decision Date: Jan 24, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

SR Nexco is intended to be used as follows: Framework-based - Veneering of metal-supported restorations . - Veneering of combination dentures (telescope crown veneers) . - Veneering of fixed-removable implant superstructures . - . Veneering of gingiva portions in fixed removable implant superstructures - Veneering of CAD/CAM fabricated metal frameworks . - Masking of model cast frameworks with SR Nexco Opaquer Pink . Framework-Free - Inlays/Onlays/veneers . - Anterior Crowns . Modification/Characterization - Superficial characterization of Ivoclar Vivadent resin teeth with SR Nexco . Stains in conjunction with SR Connect and subsequent layering with SR Nexco Paste lavering materials - Shape and shade modifications of Ivoclar Vivadent resin teeth with SR . Nexco Paste layering materials in conjunction with SR Connect - Modification and characterization of Telio CAD and Telio Lab with SR ● Nexco Stains, Dentin, Incisal and Effect Shades in conjunction with SR Connect.

Device Story

SR Nexco is a light-curing laboratory composite system used by dental technicians for the fabrication and modification of dental restorations. It functions as a veneering material for metal frameworks, implant superstructures, and CAD/CAM fabricated frameworks, or as a framework-free material for inlays, onlays, veneers, and anterior crowns. The system includes opaquer, stains, and layering pastes. It is applied in a dental laboratory setting to restore tooth structure or modify existing resin teeth and temporary restorations (Telio CAD/Lab). The material requires light-curing to achieve final physical properties. The output is a finished dental prosthetic or modified restoration, which the clinician then places in the patient's mouth to restore function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing laboratory composite resin system. Classified as a tooth shade resin material (21 CFR 872.3690). Components include opaquer, stains, and layering pastes. Designed for use with SR Connect bonding agent. Form factor is a paste/liquid system for manual application and light-cured polymerization.

Indications for Use

Indicated for dental laboratory use in the fabrication of metal-supported restorations, combination dentures, fixed-removable implant superstructures, CAD/CAM metal frameworks, inlays, onlays, veneers, and anterior crowns, as well as for the modification and characterization of resin teeth and temporary restorative materials.

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.

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

## January 24, 2013

Ivoclar Vivadent, AG C/O Ms. Donna Marie Hartnett Director Quality Assurance/ Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive AMHERST NY 14228

Re: K123304

Trade/Device Name: SR NEXCO Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 26, 2012 Received: December 27, 2012

## Dear Ms. 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.

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Page 2 - Ms. Hartnett

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame Q. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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K123304

## Indications for Use

510(k) Number (if known): K123304

Device Name: SR NEXCO

Indications For Use:

Intended Use:

SR Nexco is intended to be used as follows:

Framework-based

- Veneering of metal-supported restorations .
- Veneering of combination dentures (telescope crown veneers) .
- Veneering of fixed-removable implant superstructures .
- . Veneering of gingiva portions in fixed removable implant superstructures
- Veneering of CAD/CAM fabricated metal frameworks .
- Masking of model cast frameworks with SR Nexco Opaquer Pink .

Framework-Free

- Inlays/Onlays/veneers .
- Anterior Crowns .

Modification/Characterization

- Superficial characterization of Ivoclar Vivadent resin teeth with SR Nexco . Stains in conjunction with SR Connect and subsequent layering with SR Nexco Paste lavering materials
- Shape and shade modifications of Ivoclar Vivadent resin teeth with SR . Nexco Paste layering materials in conjunction with SR Connect
- Modification and characterization of Telio CAD and Telio Lab with SR ● Nexco Stains, Dentin, Incisal and Effect Shades in conjunction with SR Connect.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

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2013.01.23 Susan Runner DDS, Ma

14:00:27 -05'00' Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Gontrol, Dental Devices

510(k) Number:

k123304