(45 days)
Not Found
Not Found
No
The description focuses on the material properties and intended uses of a dental composite, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The device is a restorative material used in dentistry to fill cavities, act as a liner, sealant, or luting resin, which are not therapeutic functions.
No
The device is a light-cured, flowable composite used as a tooth restorative and sealant. Its purpose is to treat or restore teeth, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "light-cured, flowable composite," which is a physical material used for dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for restoring teeth, sealing pits and fissures, and other dental procedures performed directly on the patient's tooth. This is a therapeutic and restorative function, not a diagnostic one.
- Device Description: The description reinforces its use as a dental restorative material applied directly to the tooth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, which is the core definition of an IVD.
- Anatomical Site: The anatomical site is the tooth, which is a part of the living body, not a sample taken from the body.
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
EPIC-FLO is a light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is especially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercut block-out material in cavity preparations. It may be used with all currently available dentin bonding systems.
Product codes
EBF
Device Description
EPIC-FLO is a light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is especially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercut block-out material in cavity preparations. It may be used with all currently available dentin bonding systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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)
Zenith Flowable Composite, Centrix Flo-Fil, Aeliteflo, Ultradent Flowable Composite, Comp=Flow
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K973976 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
| K973976 | |||
|---|---|---|---|
| 510(k) SUMMARY | DEC - 4 1997 | ||
| Submitter: | Parkell Products Inc. | ||
| 155 Schmitt Blvd. | |||
| Box 376 | |||
| Farmingdale, NY 11735 | |||
| TEL: 516-249-1134 | |||
| FAX: 516-249-1242 | |||
| Contact: | Nelson J. Gendusa, DDS | ||
| Director of Research | |||
| Parkell | |||
| 155 Schmitt Blvd. | |||
| Box 376 | |||
| Farmingdale, NY 11735 | |||
| Submission Date: | 17 October 1997 | ||
| Trade Name: | EPIC-FLO | ||
| Common Name: | Flowable Composite Resin | ||
| Classification Name: | Tooth Shade Resin Material (C.F.R. §872.3690) | ||
| Equivalence: | Zenith Flowable Composite, Centrix Flo-Fil, Aeliteflo, Ultradent | ||
| Flowable Composite, Comp=Flow, et. al. | |||
| Description/Intended Use: | EPIC-FLO is a light-cured, flowable composite, for use as a tooth | ||
| restorative in all class cavities (I, II, III, IV and V). It is especially | |||
| suitable for use in non-stress bearing class I and III restorations | |||
| and for class V lesions. It may be used as a liner in all class cavity | |||
| preparations, and as a pit and fissure sealant or as a composite | |||
| luting resin. The material is well-suited as an undercut block-out | |||
| material in cavity preparations. It may be used with all currently | |||
| available dentin bonding systems. EPIC-FLO is substantially | |||
| equivalent to predicate devices. |
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Nelson J. Gendusa, DDS ·Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735
Re: K973976 EPIC-FLO Trade Name: Requlatory Class: II Product Code: EBF October 16, 1997 Dated: Received: October 20, 1997
Dear Dr. Gendusa:
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 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 (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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 not affect any obligation you might have under sections 531
2
Page 2 - Dr. Gendusa
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 requlation (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
3
Page _ of _
K 973976 510(k) Number (if known): -File
Indications For Use:
Device Name:
A light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is es-
pecially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity
preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercul in
cavity preparations. It may be used with all currently available dentin bonding systems.
DICC
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Om
Division of Dental, Infection Control,
and General Hospital Devicesk973976
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)