CERASYS - ZR

K042548 · Cerasys, Inc. · EIH · Dec 3, 2004 · Dental

Device Facts

• Record ID: K042548
• Device Name: CERASYS - ZR
• Applicant: Cerasys, Inc.
• Product Code: EIH · Dental
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to restore carious lesions or structural defects in teeth. Intended to restore carious and and II. V. V. V. V. V. V. V. V. Intended to restore carrous rollows for the V (Inlays & Onlays) It is intended for use in cavities Classes I, II, V (Inlays & Onlays) It is intended for use in cavities Classes it, in (223) and as a restorative material intended for veneers, crowns, and bridges.

Device Story

CeraSys-ZR is a zirconium dioxide-yttrium oxide ceramic dental restorative material. Dentists prepare tooth surfaces and obtain impressions; dental laboratories scan impressions and use computerized lathe methods to machine the ceramic into inlays, onlays, veneers, or crowns. The final restoration is returned to the dentist for permanent cementation (luting) using standard dental adhesives. The material is radio-opaque for visualization. It serves as an alternative to gold, amalgam, porcelain, or composite materials. The device is intended for use by licensed dental professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established biocompatibility of zirconia in medical/dental applications and similarity to legally marketed predicate devices.

Technological Characteristics

Zirconium dioxide-yttrium oxide ceramic. Radio-opaque. Form factor: blocks for computerized lathe machining. Processing: CAD/CAM laboratory fabrication. Luting: standard dental adhesive materials.

Indications for Use

Indicated for patients requiring restoration of carious lesions or structural defects in teeth, including Classes I, II, and V cavities, as well as 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

• Cercon (K013230)
• CynoVad Zirkon (K023327)
• Denzir (2-984201)
• 3M ESPE AG (K011394)
• Austenal (K001815)

Reference Devices

• K973221
• K971869
• K943168

Submission Summary (Full Text)

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## SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVNESS. October 8, 1998.

Submitter: Jin Kim, CeraSys, Inc. 11761 Telegraph Rd., Santa Fe Springs, CA 90670

Classification names and numbers: Porcelain powder for clinical use, 76EIH

Common / Usual name: Dental restorative material, porcelain powder / blocks

Proprietary name: CeraSys - ZR

Establishment registration number: In process

These are class II devices, intended to restore carious lesions or structural defects Classification: in teeth, described in CFR 872.3690. Like porcelain powder, this device is delivered in final form for use by the dentist, and is ceramic in nature. Porcelain powder is described in CFR 872.6660.

CeraSys - ZR is a zirconium dioxide-yttrium oxide ceramic, capable of Device description: machining by modern methods. The dentists prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or only prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesive materials. CeraSys - ZR ceramic is an alternative to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlys or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

Substantial equivalence: Similar to devices currently on the market approved through the 510K process. CeraSys - ZR is similar to Cercon K-013230, CynoVad Zirkon K-023327, Denzir 2-984201, 3M ESPE AG K-011394, Austenal K-001815

The 510K "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 luted / cemented permanently into place as inlays, and onlays.
- 2. The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use. The technological features, although distinct, have the same intended use as the devices I isted as equivalent.
- 3. Descriptive information provided shows that the material from which CeraSys ZR are made are well established as the basis of many different kinds of hip implants, requiring significantly greater forces than in the mouth. CeraSys - ZR is equivalent in use and properties devices described in K-973221, K-971869, K-943168

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- 4. Zirconia has been repeatedly tested throughout the medical and dental industry and research and has shown Zirconia to be highly biocompatible. The luting / cementing materials discussed in this summary are traditional materials well known to the dental industry.
Indications: CeraSys - ZR is used in the manufacture of dental prosthetics.

> CeraSys, Inc. proposes that the materials distributed within the United States be labeled:

> "Caution: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals"

> > (End Of Summary)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

Mr. Jin Kim CFO (Chief Financial Officer) CeraSys, Incorporated 11761 Telegraph Road Santa Fe Springs, California 90670

Re: K042548

Trade/Device Name: CeraSys ZR Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 15, 2004 Received: September 20, 2004

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews 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 miorshate comments, 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 the Federal I USA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include oone on provisions 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 (1 Mr.), it may of subject to tax 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. Kim

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/dsma/dsmamain.html

Sincerely vours,

Susan Runore

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 (if known): K042548

CeraSys ZR Device Name:

Indications for Use:

Intended to restore carious lesions or structural defects in teeth.
Intended to restore carious and and II. V. V. V. V. V. V. V. V. Intended to restore carrous rollows for the V (Inlays & Onlays)
It is intended for use in cavities Classes I, II, V (Inlays & Onlays) It is intended for use in cavities Classes it, in (223)
and as a restorative material intended for veneers, crowns, and bridges.

AND/OR Prescription Use X_ (Part 21 CFR 801 Subpart D)

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)

A. Muly for HSR

Division Sign-Off (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:

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