SHOFU BLOCK HC

K130841 · Shofu Dental Corporation · EBF · Sep 11, 2013 · Dental

Device Facts

• Record ID: K130841
• Device Name: SHOFU BLOCK HC
• Applicant: Shofu Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Sep 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental labs and manufacturers using a dental CAD/CAM system.

Device Story

SHOFU BLOCK HC is a resin-based restorative material supplied as blocks for use with dental CAD/CAM systems. Dental labs and manufacturers use the blocks to mill custom dental restorations, including inlays, onlays, laminate veneers, full crowns (anterior/posterior), and implant-supported crowns and bridges. The device serves as the raw material substrate for computer-aided manufacturing processes. By enabling digital fabrication, the device allows for the production of precise, patient-specific dental prosthetics, facilitating restorative dental procedures and improving patient oral health outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin-based restorative material supplied in block form for CAD/CAM milling. Classified under 21 CFR 872.3690 (Tooth Shade Resin Material).

Indications for Use

Indicated for fabrication of inlays, onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges. Intended for use by dental labs and manufacturers using dental CAD/CAM systems.

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

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

## September 11, 2013

Shofu Dental Corporation Mr. David P. Morais Director of Operations and Official Correspondent 1225 Stone Drive SAN MARCOS CA 92078-4059

Re: K130841

Trade/Device Name: SHOFU BLOCK HC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBG Dated: August 9, 2013 Received: August 12, 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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## 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); 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,

Mary S. Runner -S

Kwame Ulmer 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 (if known): \(30 o Y

Device Name: SHOFU BLOCK HC

Indications For Use:

For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental labs and manufacturers using a dental CAD/CAM system.

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)

Andrew | Steen - 2
2013.09.11 15:26:16 -04:00

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

510(k) Number: K130841

Shofu Dental Corporation SHOFU BLOCK HC 510(k) Premarket Notification