(90 days)
Not Found
No
The 510(k) summary describes a dental adhesive luting system and its intended uses. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device is described as an adhesive luting system for permanent cementation of dental restorations, which is a structural rather than therapeutic function.
No
Explanation: The device is an adhesive luting system used for permanent cementation of dental restorations and a try-in paste for shade matching. Its primary function is not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical material (adhesive luting system) used for cementing dental restorations, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the permanent adhesive luting (cementing) of dental restorations (inlays, onlays, veneers, crowns, bridges). This is a procedure performed directly on a patient's teeth.
- Device Description: The device is described as an adhesive luting system and try-in pastes for shade matching. These are materials used in a dental procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is a dental material used in restorative dentistry, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
- Only use Variolink Esthetic LC for restorations with a low thickness of
§ 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be moving forward.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25,2014
Ivoclar Vivadent, Inc. Donna Marie Hartnett Director QA/Regulatory Affairs 175 Pineview Drive Amherst, New York 14228
Re: K142389
Trade/Device Name: Variolink® Esthetic Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: August 8. 2014 Received: August 27, 2014
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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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 device-related 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/Resourcesfor You/Industry/default.htm. 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 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,
Susan Runno DDS, MA
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
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Indications for Use
510(k) Number (if known): K142389
Device Name: Variolink® Esthetic
Indications For Use:
Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
- Only use Variolink Esthetic LC for restorations with a low thickness of Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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510(K) SUMMARY Variolink Esthetic
Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in blue, with the words "Ivoclar" stacked on top of "Vivadent". Above the company name is a semi-circle of green and blue squares. Below the company name is the company slogan, "passion vision innovation" in black.
Contact: Donna Marie Hartnett
Company: Ivoclar Vivadent. AG Bendererstrasse 2, Schaan, FL-9494, Liechtenstein +423-235-3535
November 25, 2014 Date Prepared:
Variolink® Esthetic Proprietary Name:
Classification Name: Material, Tooth Shade, Resin (872.3690) (Classification Code EBF)
Predicate Device: Variolink II (K971372)
- Device Description: Variolink® Esthetic is a color-stable adhesive luting system for the permanent cementation of ceramic and composite resin restorations. Variolin Esthet6ic is offered in a purely light-curing (LC) and dual-curing (DC) version. Try-In pastes are also included for shade matching purposes. The materials are offered in five shade gradations (Light+, Light, Neutral, Warm and Warm+)
Intended Use: Variolink Esthetic LC:
-
Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
-
Only use Variolink Esthetic LC for restorations with a low thickness of