(72 days)
Not Found
No
The 510(k) summary describes a standard dental composite resin material and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device is a composite resin used for filling cavities and restorations, which are restorative procedures, not treatments that actively cure or alleviate a disease. It repairs damaged teeth but does not directly treat the underlying cause of the damage (e.g., bacteria in caries).
No
Explanation: The device description states it is a "light-cured nano-filled radiopaque composite resin" used for "Restoration of Class I, II, III, IV, V cavities", "Restoration of root surface caries", etc. These are all restorative or reparative functions, not diagnostic ones.
No
The device description clearly states it is a "light-cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip," 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 use clearly describes the device as a material for restoring and filling cavities in teeth. This is a direct treatment or restoration of a physical structure within the body.
- Device Description: The description details a light-cured composite resin, a material used for dental restorations.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with biological specimens outside the body for diagnostic purposes.
Therefore, MI Fil (GCUC-505) is a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
Restoration of Class 1, 11, 111, 1V, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Fixing loose teeth Additions to composite restorations
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBC, LBH
Device Description
MI Fil (GCUC-505) is a light-cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip. The device is a flowable composite resin of normal consistency. The material is available in 17 shades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (Class I, II, III, IV, V cavities, root surface, deciduous teeth)
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): 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.
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
Section 5 - Summary of 510(k)
JUL 2 2 2009
510(k) Summary for MI Fil (GCUC-505)
Submitter Information:
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 897-4042 |
| Fax: | (708) 897-4031 |
Date Prepared: May 4, 2009
Device Name:
t
| Proprietary Name: | MI Fil (GCUC-505) |
|---|---|
| Classification Name: | Tooth Shade Resin Material |
| Device Classification: | Class II, 872.23690 |
| Produce Code: | EBF |
Predicate Devices:
| Company | Device | K Number | Date Cleared |
|---|---|---|---|
| GC America Inc. | GRADIA DIRECT LoFlo | K042348 | 01/30/2003 |
| GC America Inc. | GDLS-200 (Kalore) | K082434 | 11/14/2008 |
| Ivoclar Vivadent, Inc. | TETRIC EVOCERAM | K042819 | 11/09/2004 |
Description of Device:
MI Fil (GCUC-505) is a light-cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip. The device is a flowable composite resin of normal consistency. The material is available in 17 shades.
Indications for use:
Restoration of Class 1, 11, 111, 1V, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Fixing loose teeth Additions to composite restorations
Decription of Safety and Substantial Equivalence:
The applicant device is substantially equivalent to the predicate devices in its intended use. They are all composite resins and are used for the restorations of both anterior teeth. They are also used as a filling material and sealant.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized with three distinct wing-like shapes, and it is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 222009
Mark Heiss, D. D. S. Director of New Business Development and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K091388
Trade/Device Name: MI Fil (GCUC-505) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC, LBH Dated: May 4, 2009 Received: May 11, 2009
Dear Dr. Heiss:
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.
2
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 free 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,
Susan Runne,
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 6 - Indications for Use Statement
Indications for Use
510(k) Number (if known): K091385
Device Name: MI Fil (GCUC-505)
Indications for Use:
Intended use
Restoration of Class I, II, III, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting mobile teeth Additions to composite restorations
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kai Mulvey for WSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital -Infection Control, Dental Devices
510(k) Number: K091388
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