← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K071742

# BEAUTIFIL II (K071742)

_Shofu Dental Corp. · EBF · Aug 15, 2007 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K071742

## Device Facts

- **Applicant:** Shofu Dental Corp.
- **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md)
- **Decision Date:** Aug 15, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3690
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.

## Device Story

Beautifil II is a visible light-curing, radiopaque dental composite resin. Used by dentists in clinical settings for restorative procedures. Applied to tooth structures to fill cavities (Class I-V), repair defects, or perform core build-ups. Material is placed into the prepared tooth site and cured using a dental light-curing unit. Provides structural restoration and aesthetic repair of teeth and dental materials. Benefits include restoration of tooth function and appearance.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Visible light-curing dental composite resin; radiopaque; supplied as a paste for restorative applications. Material properties consistent with standard dental resin composites (21 CFR 872.3690).

## Regulatory 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

AUG 1 5 2007

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

Re: K071742

Trade/Device Name: Beautifil II Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 21, 2007 Received: June 27, 2007

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. 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu, Li-Pi, D.D.S.

Chiu Lin, Ph.D. 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

510(k) Number (if known): K071742

Device Name: Beautifil II

Indications For Use:

BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.

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

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

X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Penner

ാട്ടിon Sign-Off) Civision of Anesthesiology, General Hospital Shofu Dental Corporation Onora Dental Ochton Corporation Instition Control, Dental Devices

Number: 16071246

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