BEAUTIFIL FLOW

K051818 · Shofu Dental Corp. · EBF · Aug 3, 2005 · Dental

Device Facts

• Record ID: K051818
• Device Name: BEAUTIFIL FLOW
• Applicant: Shofu Dental Corp.
• Product Code: EBF · Dental
• Decision Date: Aug 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

BEAUTIFIL Flow is a radiopaque, light cured fluoride releasing flowable restorative material for esthetic restoration intended for use in anterior restoration involving class III, class IV, class V (such as cervical caries, root surface caries, and wedge shaped defects), small posterior restoration (class I and II) without occlusal stress bearing, and restoration of deciduous.

Device Story

BEAUTIFIL Flow is a light-cured, radiopaque, fluoride-releasing flowable resin composite; used by dental professionals in clinical settings for restorative dentistry. Material is applied to prepared tooth cavities (anterior/small posterior) to restore form and function; cured via dental light-curing unit. Provides esthetic repair for caries and defects; fluoride release intended to support dental health. Device is a restorative material; no electronic components, software, or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque, light-cured, fluoride-releasing flowable resin composite. Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for esthetic dental restorations in patients requiring treatment for anterior class III, IV, and V lesions (cervical/root caries, wedge defects), small non-stress-bearing posterior class I and II restorations, and deciduous teeth.

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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Public Health Service

AUG 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David P. Morais Operations Manager Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059

Re: K051818

Trade/Device Name: BEAUTIFIL Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 30, 2005 Received: July 05, 2005

Dear Mr. Morais:

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.

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Page 2 – Mr. David P. Morais

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); 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Qurs

Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

1051818 510(k) Number (if known):

Device Name: BEAUTIFIL Flow

Indications for Use:

BEAUTIFIL Flow is a radiopaque, light cured fluoride releasing flowable restorative material for esthetic restoration intended for use in anterior restoration involving class III, class IV, class V (such as cervical caries, root surface caries, and wedge shaped defects), small posterior restoration (class I and II) without occlusal stress bearing, and restoration of deciduous.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Penner

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

510(k) Number:

Shofu Dental Corporation BEAUTIFIL Flow 510(k) Premarket Notification