VINTAGE LD

K152392 · Shofu Dental Corporation · EIH · Jan 8, 2016 · Dental

Device Facts

• Record ID: K152392
• Device Name: VINTAGE LD
• Applicant: Shofu Dental Corporation
• Product Code: EIH · Dental
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Build up porcelain for fabrication of all ceramic restorations including lithium disilicate

Device Story

VINTAGE LD is a porcelain powder used by dental technicians in a laboratory setting to build up and fabricate all-ceramic dental restorations, specifically those involving lithium disilicate frameworks. The material is applied to the framework to achieve desired anatomical shape and aesthetic properties. The final restoration is then placed by a dentist to restore patient tooth function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Porcelain powder for dental ceramic restoration. Material composition is consistent with standard dental ceramics used for lithium disilicate frameworks. Form factor is a powder for manual application/build-up. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in the fabrication of all-ceramic dental restorations, including those utilizing lithium disilicate, for patients requiring dental prosthetics.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

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

January 8, 2016

Shofu Dental Corporation Mr. Mauro Malzyner Regulatory Affairs and Official Correspondent 1225 Stone Drive San Marcos, California 92078

Re: K152392

Trade/Device Name: VINTAGE LD Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: December 2, 2015 Received: December 4, 2015

Dear Mr. Malzyner:

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

**Indications for Use**

| 510(k) Number (if known) | K152302 |
|--------------------------|---------|
|--------------------------|---------|

Device Name

VINTAGE LD

Indications for Use (Describe)

Build up porcelain for fabrication of all ceramic restorations including lithium disilicate

| Type of Use (Select one or both, as applicable) | <table><tr><td><span> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <span> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | |

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