(49 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and predicate devices suggest a dental adhesive/bonding agent.
No
The device's intended uses, such as adhesion of dental prosthetics and repair of dentures, indicate it is a dental material or adhesive, not a device used for treating disease or health conditions.
No
The device is used for dental restorative procedures like adhesion, repair, and fabrication, not for diagnosing medical conditions.
No
The 510(k) summary describes a device used for dental procedures involving adhesion and repair of dental prosthetics and materials. The intended uses clearly point to a physical product (adhesives, repair materials) rather than a software application. The lack of any mention of software, image processing, AI, or data analysis further supports this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (adhesion of dental restorations, repair of crowns and dentures, fabrication of dentures) are all related to dental procedures performed directly on or in the patient's mouth.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
- Predicate Devices: The listed predicate devices (V-PRIMER, SILOC SYSTEM, CLEARFIL PORCELAIN BOND, ACRYLIC SOLDER) are all known dental materials used for bonding, repair, and fabrication in dentistry. These are not IVD devices.
Therefore, based on the intended use and the nature of the predicate devices, this device falls under the category of a dental material or device used in restorative or prosthetic dentistry, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is used for the following indications. All of these intended use are same to those of predicate devices. 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges. 2)Repair of fractures resin-based facing crowns and porcelain-fused metal crowns 3)Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Koji Fujita President Kuraray America, Incorporated 200 Park Avenue New York, New York 10166
DEC 17 1997
K974089 Re : Trade Name: Alloy Primer Requlatory Class: II Product Code: KLE Dated: October 29, 1997 Received: October 29, 1997
Dear Mr. Fujita:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
1
Page 2 - Mr. Fujita
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page / of /
K 974089 510(k) Number (if known):
ALLOY PRIMER Device Name:
Indications For Use:
Statement of the intended use.
This device is used for the following indications. All of these intended use are same to those of predicate devices.
- Adhesion of metal posts, metal inlays, onlays, crown and bridges.
Similar products
V-PRIMER (K942917)
SILOC SYSTEM (K970848)
2)Repair of fractures resin-based facing crowns and porcelain-fused metal crowns Similar product
CLEARFIL PORCELAIN BOND (K871636)
3)Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures
Similar product
ACRYLIC SOLDER by PARKELL PRODUCT, INC.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearce
(Division Sign-Off) Division of Dental, Info on Control. and General Hosp 510(k) Number
Prescription Use V (Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Format 1-2-96)