(92 days)
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No
The provided text describes a dental veneering material and its intended uses, with no mention of AI or ML technology.
No
The device is described as a material (SR Nexco) used for veneering and modifying dental restorations and teeth, which are structural or aesthetic applications, not therapeutic treatments for disease or injury.
No
The Intended Use describes the device as a material for veneering, modification, and characterization of dental restorations and teeth, which are all treatment or restorative functions, not diagnostic ones.
No
The intended use describes a material used for veneering and modifying dental restorations and prosthetics, 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 dental restorations and modifications, which are procedures performed directly on or in the patient's mouth. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any other activities typically associated with IVDs.
Therefore, SR Nexco appears to be a dental material used for restorative and cosmetic purposes, not a diagnostic device.
N/A
Intended Use / 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.
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
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.
1
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 (800) 638-2041 or (301) 796-7100 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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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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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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: