BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK

K132748 · Shofu Dental Corporation · EBF · Dec 4, 2013 · Dental

Device Facts

• Record ID: K132748
• Device Name: BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Dec 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BEAUTIFIL e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations. BEAUTIFIL e Posterior (Indications) - Direct posterior restorations . - Repair of restorations and prostheses ● BEAUTIFIL Bulk (Indications) Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

Device Story

BEAUTIFIL e Posterior / BEAUTIFIL Bulk are light-curing resin paste materials used by dental professionals in clinical settings for direct posterior restorations and repair of prostheses. The device functions as a restorative material; Universal and A shades (BEAUTIFIL Bulk) feature reduced pigment content for high transparency and increased depth of cure. Applied by dentists to the tooth structure, the material is light-cured to harden, providing structural restoration and aesthetic masking of substructures. The output is a cured, tooth-colored resin restoration that restores function and appearance to the patient's dentition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing resin paste; 28 available shades; Universal and A shades formulated with reduced pigment for high transparency and increased depth of cure. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for direct posterior restorations and repair of dental restorations and prostheses in patients requiring restorative dental procedures. BEAUTIFIL Bulk is specifically indicated for direct posterior restorations to mask substructure color.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## December 4, 2013

Shofu Dental Corporation Mr. David P. Morias Director of Operation and Official Correspondent 1225 Stone Drive San Marcos, California 92078

Re: K132748

Trade/Device Name: BEAUTIFIL e Posterior / BEAUTIFIL Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 18, 2013 Received: September 23, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O.

for

# Ulmer -S

Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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: K132748

Device Name: BEAUTIFIL e Posterior / BEAUTIFIL Bulk

## Indications for Use:

BEAUTIFIL e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations.

## BEAUTIFIL e Posterior

(Indications)

- Direct posterior restorations .
- Repair of restorations and prostheses ●

### BEAUTIFIL Bulk

(Indications)

Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

Prescription Use × (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)

: Mary S. Runner -S 15.00 2013.12.03 12:30:47 -05'00'

Shofu Dental Corporation BEAUTIFIL e Posterior / BEAUTIFIL Bulk 510(k) Premarket Notification x