UNIFIL FLOW

K020342 · GC America, Inc. · EBF · Mar 28, 2002 · Dental

Device Facts

• Record ID: K020342
• Device Name: UNIFIL FLOW
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC UniFil Flow is intended to be used for small class I & II :restora ions. · And Class III, IV and V restorations. Other uses include: Base and Liner, sealing for hypersensitivity, Pit and fissure sealar fixation of mobile teeth and repair of resin composite.

Device Story

GC UniFil Flow is a light-cured, radiopaque, flowable resin composite material. It is used by dental professionals in a clinical setting for various restorative procedures, including cavity filling, sealing, and tooth fixation. The material is applied directly to the tooth structure and cured using a dental curing light. It serves as a restorative or protective agent to improve tooth function and aesthetics. No complex algorithms or software are involved in its operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, radiopaque, flowable resin composite material. Class II device under 21 CFR 872.3690. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restorations including small Class I and II, Class III, IV, and V restorations, base and liner applications, hypersensitivity sealing, pit and fissure sealing, fixation of mobile teeth, and repair of resin composite.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2002

Ms. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K020342

Trade/Device Name: UniFil Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: January 31, 2002 Received: February 01, 2002

Dear Ms. Joritz:

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 such 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.

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.

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## Page 2 - Ms. Joritz

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cucenita Hoc

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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11020342 5 10(k) Number (if known): -

Device Name: GC UniFil Flow

Indications For Use:

GC UniFil Flow is intended to be used for small class I & II :restora ions. · And Class III, IV and V restorations. Other uses include: Base and Liner, sealing for hypersensitivity, Pit and fissure sealar fixation of mobile teeth and repair of resin composite.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)

Susar Russo

(Division Sign-Off) Civision of Dental, Infection Control, and General Hospital Devices -