EPIC-FLO

K973976 · Parkell, Inc. · EBF · Dec 4, 1997 · Dental

Device Facts

• Record ID: K973976
• Device Name: EPIC-FLO
• Applicant: Parkell, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

EPIC-FLO is a light-cured, flowable composite resin used by dentists for tooth restoration. It functions as a restorative material for various cavity classes (I-V), a cavity liner, a pit and fissure sealant, a luting resin, and an undercut block-out material. The material is applied by the clinician into the prepared cavity and cured using a dental light-curing unit. It is compatible with existing dentin bonding systems. The device aids in restoring tooth structure and function, benefiting patients by providing a versatile, flowable material for diverse dental restorative needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, flowable composite resin. Designed for use with standard dentin bonding systems. Formulated for flowability to facilitate placement in cavity preparations, liners, and sealants.

Indications for Use

Indicated for patients requiring dental restorations in all class cavities (I, II, III, IV, and V), including non-stress bearing class I and III restorations, class V lesions, cavity liners, pit and fissure sealants, composite luting, and undercut block-outs.

Regulatory Classification

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.

Predicate Devices

• Zenith Flowable Composite
• Centrix Flo-Fil
• Aeliteflo
• Ultradent Flowable Composite
• Comp-Flow

Submission Summary (Full Text)

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K973976 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

| K973976 | | | |
|---------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | | 510(k) SUMMARY | DEC - 4 1997 |
| | Submitter: | Parkell Products Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: [phone]<br>FAX: [phone] | |
| | Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>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<br>Flowable Composite, Comp=Flow, et. al. | |
| | Description/Intended Use: | EPIC-FLO is a light-cured, flowable composite, for use as a tooth<br>restorative in all class cavities (I, II, III, IV and V). It is especially<br>suitable for use in non-stress bearing class I and III restorations<br>and for class V lesions. It may be used as a liner in all class cavity<br>preparations, and as a pit and fissure sealant or as a composite<br>luting resin. The material is well-suited as an undercut block-out<br>material in cavity preparations. It may be used with all currently<br>available dentin bonding systems. EPIC-FLO is substantially<br>equivalent to predicate devices. | |

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)