(104 days)
Not Found
Not Found
No
The summary describes a dental composite material and its intended uses, focusing on its chemical properties and applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an injectable composite material for various dental restorations (filling, cementing, core build-up), which are restorative procedures, not therapeutic treatments.
No
The device, Injectafil™, is described as an injectable composite material used for dental restorations, cementing indirect restorations, or as a core build-up material. Its uses are therapeutic and restorative, not diagnostic.
No
The device description clearly states it is an "injectable composite material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Injectafil™ is a dental material for direct restorations, resin cement, or core build-up. These are all applications within the mouth for structural or restorative purposes.
- Device Description: The description reinforces its use as an injectable composite material for dental procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or samples.
Therefore, Injectafil™ falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.
Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.
Product codes (comma separated list FDA assigned to the subject device)
EBF, KLE
Device Description
Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.
Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.
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
Prescription use
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like bird with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
SEP 21 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Chris Kulton Apex Dental Materials, Incorporated 330 Telser Road Lake Zurich, Illinois 60047
Re: K091647
Trade/Device Name: InjectafilTM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, KLE Dated: September 14, 2009 Received: September 17, 2009
Dear Mr. Kulton:
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.
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- Mr. Kulton
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Susan Runner, D.D.S., M.A. Acting Division 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:
Injectafil™
Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.
Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate
based dental materials.
Kain Muluy for MS
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510 (k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription use X (Per 21 CFR 801.109 OR
Over- The- Counter Use
(Optional Format 1-2-96)
510K Submission for Injectafil™ Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
CONFIDENTIAL
Page 4 of 18