HEANY INDUSTRIES INC DENTAL XIRCONIA

K073314 · Heany Industries, Inc. · EIH · Feb 21, 2008 · Dental

Device Facts

• Record ID: K073314
• Device Name: HEANY INDUSTRIES INC DENTAL XIRCONIA
• Applicant: Heany Industries, Inc.
• Product Code: EIH · Dental
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, crowns and bridges.

Device Story

Heany Industries Inc. Dental Zirconia is a zirconium oxide ceramic core material provided as blocks or disks. It is intended for use by dental professionals in a CAD/CAM workflow to fabricate copings and substrates for fixed all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges. The material is milled by the customer using CAD/CAM systems and subsequently hardened in an oven. The final restoration is placed above the gum line. The device provides a structural core for dental prosthetics, benefiting patients by enabling the creation of durable, aesthetic all-ceramic restorations.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing of physical and mechanical properties and biocompatibility assessments comparing the device to predicate materials.

Technological Characteristics

Material: Zirconium oxide (ZrO2) ceramic. Form factor: Blocks or disks. Processing: CAD/CAM milling followed by oven hardening. Intended for fixed all-ceramic dental restorations (inlays, onlays, veneers, crowns, bridges).

Indications for Use

Indicated for use as a non-implantable material for the CAD/CAM fabrication of core material for all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges.

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.

Predicate Devices

• Foundation Milling Center Z-Blocks (K060389)
• LAVA™ Frame (K011394)
• IPS E.MAX CAD/IPS E.MAX ZIRCAD (K051705)

Submission Summary (Full Text)

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# V. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitter

FEB 21 2008

| Name: | Heany Industries Inc |
|-----------|--------------------------------|
| Street: | 249 Briarwood Lane |
| City: | Scottsville |
| State: | NY |
| Zip-Code: | 14546 |
| Country: | USA |
| Contact: | Corey Dunn<br>Ceramic Engineer |
| Phone: | 585-889-2700 |
| Fax: | 585-889-2708 |
| E-mail: | [e-mail] |
| Date: | 11/16/07 |

Name of Device

| Proprietary Name: | Heany Industries Inc. Dental Zirconia |
|----------------------|---------------------------------------|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | All-ceramic core material |

## Predicate Devices

Foundation Milling Center Z-Blocks .......K06 389 (Foundation Milling Center (FMC)

LAVA™ Frame:...............................................K011394 (3M ESPE AG)

IPS E.MAX CAD/IPS E.MAX ZIRCAD ... K051705 (Ivoclar Vivadent, Inc.)

## Description for the Premarket Notification

Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.

The technological characteristics between the predicate and proposed devices are identical. All chemical ingredients for the proposed device are already contained in the predicate devices. Biocompatibility, physical and mechanical properties have been tested to show Heany Industries Inc. Dental Zirconia is as safe and effective as the predicate devices.

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FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Corey Dunn Ceramic Engineer Heany Industries Incorporated 249 Briarwood Lane Scottsville, New York 14546

Re: K073314

Trade/Device Name: Heany Industries Incorporated Dental Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 20, 2007 Received: November 26, 2007

Dear Mr. Dunn:

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. Dunn

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]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Elsie Rivera-Velez

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 : K073314

Device Name: __ Heany Industries Inc. Dental Zirconia

Indications for Use:

Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, crowns and bridges.

Prescription Use X (Part 21 CFR 801 Subpart D)

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> Concurrence of CDRH, Office of Device Evaluation (ODE) Syson funner (Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

:

510(k) Number: x x o 7 33 /4

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