(96 days)
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No
The provided text describes a dental adhesive and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical and functional properties of the adhesive.
No
The device is described as an adhesive for dental restorations, which is a material used for treatment, not a device that treats a condition itself.
No
The provided text describes the device as an adhesive for dental restorations, not a tool for diagnosis.
No
The intended use describes a light-curing adhesive, which is a physical material used in dental procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an adhesive for dental restorations (composites, compomers, ceramics). This is a direct application within the patient's mouth for treatment purposes.
- Lack of IVD Characteristics: IVDs are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of Excite® F and Excite® F DSC does not involve any such testing of specimens.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Excite® F is a light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for:
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Adhesive for direct light-curing and dual curing composite and compomer restorations
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Adhesive for indirect all-ceramic and composite restorations (inlays, onlays, veneers; only light-curing)
Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride release intended for use in clinical situations for:
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Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II)
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direct restorations and core build ups with dual and self curing compositions (e.g. Multicore)
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Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)
Product codes
KLE
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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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
MAR 1 0 2010
Re: K093744
Trade/Device Name: Excite F & Excite F DSC Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 16, 2010 Received: February 22, 2010
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 (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 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hh for
Anthony D. Watson, B.S.. M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known):
Device Name: Excite F & Excite F DSC Indications For Use:
Excite® F is a light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for:
-
Adhesive for direct light-curing and dual curing composite and compomer restorations
-
Adhesive for indirect all-ceramic and composite restorations (inlays, onlays, veneers; only light-curing)
Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride release intended for use in clinical situations for:
-
Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II)
-
direct restorations and core build ups with dual and self curing compositions (e.g. Multicore)
-
Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
RsBet. DiDsofor Dr.K.P. Mul
Division Sign-Off)
Concurrence of CDRH, Office c
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K09374 510(k) Number: __
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