PSL BIOZIR BLOCK

K073568 · P.S.L. International, Inc. · EIH · Feb 6, 2008 · Dental

Device Facts

• Record ID: K073568
• Device Name: PSL BIOZIR BLOCK
• Applicant: P.S.L. International, Inc.
• Product Code: EIH · Dental
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Device Story

PSL BioZir Block is a zirconium dioxide-yttrium oxide ceramic material; supplied as blocks for machining. Dental laboratory technicians use CAD/CAM systems or computerized lathes to mill blocks into finished dental prostheses (crowns, inlays, onlays, veneers, bridges). Finished prostheses are sent to dentists for cementation/luting into patient teeth to restore structural defects or carious lesions. Material is radio-opaque for visualization. Benefits include high-strength ceramic restoration as an alternative to gold, amalgam, or composite materials.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by descriptive information, material properties, and successful prior use of components in legally marketed devices.

Technological Characteristics

Zirconium dioxide-yttrium oxide ceramic. Supplied as partially sintered blocks for CAD/CAM machining; fully sintered after milling. Radio-opaque. Material properties similar to established dental ceramics and hip implant materials.

Indications for Use

Indicated for patients requiring restoration of carious lesions or structural tooth defects, including Classes I, II, and V cavities, as well as fabrication of crowns, facings, inlays, onlays, veneers, and anterior/posterior bridge restorations.

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

• Sagemax Z-Blank (IN-S26(S))
• Xavex (K050903)
• Medin Tech Zirconia CP10, 1000 (K043472)
• Cynovad Zirkon (K023327)
• Denzir (Dentronic AB) (K984201)
• Cercon Base (Degussa Dental) (K013230)

Reference Devices

• Austenal DC Zirkon (001815)

Submission Summary (Full Text)

{0}------------------------------------------------

K073568

## 510 (k) SUMMARY

FEB - 6 2000

Submitter: Catherine Feng, PSL International, Inc. 1424 Hymus, City of Dorval, Quebec, HpP 1J6, Canada.

I. Classification Names and numbers: Porcelain powder for clinical use, EIH, Class II, described in CFR 872,6660.

II. Common/Usual Name: Dental restorative material, porcelain powder/blocks

III. Proprietary Names: PSL BioZir Block-TM

IV. Establishment Registration Number: In process

V. Device Description: PSL BioZir Block™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. PSL BioZir Block™ (when it reaches the dentist, like opercelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay, or crown inprepsived or modern computerized lathe methods and returned to the dentist then prepares the final tooth surfaces involved and cements (lutes) the prosthesis in place with standard departs adle timal (luting) materials. PSL BioZir Block™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcely inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-onage, for ready visualization.

VI. Substantial Equivalence: Relative to devices currently on the market, cleared by the 510(k) process, PSL International, Inc. is substantially equivalent to Sagemax Z-Blank, cleared in IN-S26(S), to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000™ cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to Denzir" (Dentronic AB) cleared under K984201 as well as Cercon Base™ (Degussa Dental) cleared under K-013230.

Like Sagemax Z-blank, it is intended to be marketed as a partially sintered device which will then be machined and fully sintered. Like Austenal's DC Zirkon (001815) it can be used in the DSS CAD/CAM system, and in the CNC milling machine, or other CAD/CAM system meeting the requirements of the recently issued FDA Class II Special Controls Guidance for Optical Ironpression System ... for Dental Restorations.

The successful prior use of the components of PSL BioZir Block™ product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the ubantantial equivalence of PSL BioZir Block" to prior 510(k) cleared devices support the safety and effectiveness of the PSL International, Inc. M product for the intended use.

XI.

{1}------------------------------------------------

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, to be cemented/luted into place as inlays, onlays, veneers or crowns and for bridge components the repair of damaged teeth.

2. The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for slight differences in methods of use. In addition, the technological differences are well understood in the dental industry. The use of a computerized lathe system to prepare the inlay or only, when used in the dental office, also has been cleared by 510(k)--K950299 and K972276 and others.

3. Descriptive information provided shows that the materials from which this device is made were well-established in the more demanding areas of hip implants. They resemble the properties of finished porcelain products and usually will have porcelain finishes.

4. The FDA "Decision-Making Process" chart was used.

[End of Summary]

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Catherine Feng President P.S.L. International, Incorporated 1424 Hymus, Suite 15 Dorval, Quebec H9P 116 CANADA

Re: K073568

Trade/Device Name: PSL BioZir Block™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 11, 2007 Received: December 20, 2007

Dear Ms. Feng:

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.

{3}------------------------------------------------

Page 2- Ms. Feng

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.

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

{4}------------------------------------------------

## VIII. Indications for Use: [Separate Page]

KO73568 510(k) Number: NA

Device Name: PSL BioZir Block™

Indications for use:

Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Prescription Use (Per 21 CFR 801.Subpart D )

OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
|--------------------------------------------------------------------------------------------|---------|
| <div style="text-align:center;"> <span style="font-size: large;">Susan Rasor</span> </div> | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K073568 |

4