FLOWABLE HYBRID

K980298 · Cosmedent, Inc. · EBD · Mar 9, 1998 · Dental

Device Facts

• Record ID: K980298
• Device Name: FLOWABLE HYBRID
• Applicant: Cosmedent, Inc.
• Product Code: EBD · Dental
• Decision Date: Mar 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Flowable Hybrid is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.

Device Story

Flowable Hybrid is a dental restorative material used by dentists for various clinical applications including Class V and small occlusal restorations, margin sealing, defect repair, pit and fissure sealing, splint bonding, and direct resin veneers. The material is applied directly to the tooth structure or restoration site to fill voids, seal margins, or bond components. It functions as a restorative resin composite. The device is intended for professional use in a clinical dental setting. It benefits patients by restoring tooth structure, sealing margins against microleakage, and repairing dental defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flowable Hybrid is a resin-based dental restorative material. It is a flowable composite designed for direct application in dental procedures. It is a standalone device, non-sterile, and intended for professional use.

Indications for Use

Indicated for dental patients requiring Class V restorations, small occlusal restorations, margin sealing, repair of pitted areas or marginal defects in restorations, pit and fissure sealing, bonding of fibrous splints, and direct resin veneers.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1998

Mr. Michael O'Malley President Cosmedent, Incorporated 5419 North Sheridan Road Chicago, Illinois 60640

K980298 Re : Flowable Hybrid Trade Name: Requlatory Class: II Product Code: EBD Dated: January 26, 1997 January 27, 1997 Received:

Dear Mr. O'Malley:

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 requlations affecting your device can be found in the Code of Federal Regulations, 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 Devices: General requlation (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 Reqister. 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 - Mr. O'Malley

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,

Patricia Cucenati /for

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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Cosmedent, Inc.

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ Flowable Hybrid ______________________________________________________________________________________________________________________________________________________________

Indications for Use:

Flowable Hybrid is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | PDS for MSR |
|---------------------------------------------------------------------|-------------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980298 |
| Prescription Use | 44 |

escription U (Per 21 CFR 801.109) OR

Over-the-Counter Use No