HY-BOND RESIGLASS

K111855 · Shofu Dental Corp. · EMA · Nov 17, 2011 · Dental

Device Facts

• Record ID: K111855
• Device Name: HY-BOND RESIGLASS
• Applicant: Shofu Dental Corp.
• Product Code: EMA · Dental
• Decision Date: Nov 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.

Device Story

Hy-Bond Resiglass is a dental cement used by dental professionals for the permanent fixation of restorations and orthodontic appliances to natural tooth structure. It functions as a bonding agent between the restorative material (metal, ceramic, or resin) and the tooth surface. The device is supplied for clinical use in dental offices. It facilitates the secure attachment of dental prosthetics and appliances, aiding in the restoration of dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement; resin-modified glass ionomer composition; intended for permanent cementation of dental restorations and orthodontic appliances; class II device (Product Code: EMA).

Indications for Use

Indicated for cementation of metal, ceramic, or resin dental restorations (inlays, crowns, bridges) and orthodontic appliances (metal or ceramic brackets) to natural teeth.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

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

Mr. David P. Morais Operations Manager and Official Correspondent SHOFU DENTAL CORPORATION 1225 Stone Drive San Marcos, California 92078

FEB -3 2012

Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 19, 2011 Received: October 20, 2011

Trade/Device Name: Hy-Bond Resiglass

Dear Mr. Morais:

Re: K111855

This letter corrects our substantially equivalent letter of November 17, 2011.

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 [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,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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):

· Device Name: Hy-Bond Resiglass

Indications For Use:

Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K111855 |
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Shofu Dental Corporation

HY-BOND RESIGLASS 510(k) Premarket Notification

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