(74 days)
K-013230, K-023327, 2-984201, K-011394, K-001815
K-973221, K-971869, K-943168
No
The description focuses on the material composition and the manufacturing process using computerized lathe methods, which is not indicative of AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is a restorative material for repairing carious lesions and structural defects in teeth, acting as a replacement for other filling materials. It does not provide therapy or treatment for a disease.
No
This device is described as a restorative material (zirconium dioxide-yttrium oxide ceramic) for dental fillings, veneers, crowns, and bridges, prepared in a dental laboratory and cemented by a dentist. Its function is to restore structural defects, not to diagnose them.
No
The device description clearly states it is a ceramic material (zirconium dioxide-yttrium oxide) that is machined in a dental laboratory. This is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore carious lesions or structural defects in teeth, and to be used as a restorative material for veneers, crowns, and bridges. This is a direct treatment/restoration of a physical structure within the body (teeth).
- Device Description: The device is a ceramic material used to create dental restorations (inlays, onlays, veneers, crowns, bridges) that are then placed in the patient's mouth.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a restorative material used on the body.
N/A
Intended Use / Indications for Use
CeraSys ZR is:
Intended to restore carious lesions or structural defects in teeth.
It is intended for use in cavities Classes I, II, V (Inlays & Onlays)
and as a restorative material intended for veneers, crowns, and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists / dental laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-013230, K-023327, 2-984201, K-011394, K-001815
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K-973221, K-971869, K-943168
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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:
-
- These products have the same intended use, to be luted / cemented permanently into place as inlays, and onlays.
-
- 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.
-
- 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
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.
- 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.
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.
3
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
4
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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