CERASYS - ZR by CERASYS, INC. | FDA 510(k) Summary

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 Description

CeraSys - ZR is a zirconium dioxide-yttrium oxide ceramic, capable of 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.

AI/ML Overview

This document is a 510(k) summary for the CeraSys - ZR dental restorative material and does not contain a study demonstrating the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy.

The document focuses on establishing substantial equivalence to existing legally marketed devices, rather than conducting a performance study with defined acceptance criteria and statistical analysis.

Therefore, I cannot provide the requested information in the format given because the input document does not contain a study that proves the device meets acceptance criteria you've outlined.

However, I can extract information related to the substantial equivalence claim, which is the basis for FDA clearance for this device:

Basis for Substantial Equivalence (as presented in the document):

Same Intended Use: To be luted/cemented permanently into place as inlays and onlays; also for veneers, crowns, and bridges. (Pages 1 & 4)
Similar Technological Characteristics: The technological characteristics are similar to those for predicate devices and those currently on the market, with differences noted in methods of use. The device is a zirconium dioxide-yttrium oxide ceramic capable of machining by modern methods. (Page 1)
Well-Established Material: Zirconium dioxide-yttrium oxide ceramic is a material well-established as the basis of many different kinds of hip implants (requiring significantly greater forces than in the mouth). Zirconia has been repeatedly tested throughout the medical and dental industry and research and has shown to be highly biocompatible. The luting/cementing materials are traditional and well known to the dental industry. (Pages 1 & 2)

Predicate Devices for Substantial Equivalence:

Cercon K-013230
CynoVad Zirkon K-023327
Denzir 2-984201
3M ESPE AG K-011394
Austenal K-001815
Devices described in K-973221, K-971869, K-943168

Missing Information (not applicable to a 510(k) substantial equivalence submission of this type):

The following points from your request are not applicable to this document as it describes a 510(k) premarket notification based on substantial equivalence, not a direct performance study with defined acceptance criteria for a new device's efficacy or accuracy against a ground truth:

A table of acceptance criteria and the reported device performance: No specific performance metrics like sensitivity, specificity, or accuracy with corresponding acceptance criteria are reported.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is a dental material, not an AI device).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) document asserts the safety and effectiveness of the CeraSys - ZR device by demonstrating its substantial equivalence to currently marketed devices, primarily based on intended use, technological characteristics, and material biocompatibility, rather than through a a new performance study with acceptance criteria against a defined ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K042548" in a handwritten style. Above the right side of the text, the words "Page 66" are printed in a smaller font size. The text appears to be a page number or some other kind of identifier.

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.
1. 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.
1. 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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1. 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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:

Page 1 of 1

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
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.(b)
Classification. Class II.