(56 days)
Not Found
No
The description focuses on the material composition and physical characteristics of a dental blank used in CAD/CAM fabrication, with no mention of AI or ML.
No
The ZIROX is a dental blank used for manufacturing dental restorations, not a device that directly interacts with the patient for therapeutic purposes.
No
The provided text states that ZIROX is "intended for CAD/CAM fabrication of all-ceramic dental restorations" and "used for the manufacturing of inlays, onlays, veneers, crowns and bridges." It is a material (dental blank) used for manufacturing, not for diagnosing medical conditions.
No
The device description clearly states that ZIROX is a "pre-formed machineable dental blank composed of zirconium oxide," which is a physical material, not software.
Based on the provided information, the ZIROX device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the CAD/CAM fabrication of dental restorations (inlays, onlays, veneers, crowns, and bridges). This is a manufacturing process for creating physical dental prosthetics.
- Device Description: ZIROX is a pre-formed blank of zirconium oxide, a material used to build these dental restorations. It's a raw material that is machined into the final product.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
- Being used in a laboratory setting for diagnostic purposes.
The ZIROX is a material used in the manufacturing of medical devices (dental restorations), but it is not a diagnostic device itself.
N/A
Intended Use / Indications for Use
The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height).
ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
customers/dental laboratories
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.
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.
Not Found
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.
0
510(k) SUMMARY
OCT 2 2 2009
Submitter:
| Name: | |
|---|---|
| Carreland Controller | |
| Address: |
ZENČERA, INC. Room 1108, ACE Techno Tower 5th Building, 197-22, Guro3-Dong, Guro-Gu, Seoul, Republic of Korea, 152-766
| Name: | Haeryang Joo |
|---|---|
| Address: | 4525 Wilshire Blvd., Los Angeles, CA, 90010, U.S.A |
| Phone No.: | +1-323-935-0606 |
| Fax No.: | +1-323-935-7779 |
| E-Mail: | sylee68@gmail.com |
Official Correspondent:
| Name: | San-ho Hyun |
|---|---|
| Address: | Room 1108, ACE Techno Tower 5th Building, 197-22, Guro |
| Dong, Guro-Gu, Seoul, Republic of Korea, 152-766 | |
| Phone No.: | +82-2-2109-0955 |
| Fax No.: | +82-2-2109-0957 |
| E-Mail: | sanho0517@hanmail.net |
Device Identification
| Proprietary Name: | ZIROX |
|---|---|
| Common/Usual Name: | Porcelain Powder |
| Classification Name: | Porcelain Powder for Clinical Use |
| Product Code: | EIH |
| Review Panel: | Dental |
| Regulation Number: | 872.6660 |
Substantially Equivalent Predicate Legally Marketed Devices
The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.
1
| Device Name | Dentsply-Cercon
Base | 3M-LAVA Zirconia | Sagemax
Bioceramics-
Sagemax Z-Blank |
|-------------------|-----------------------------|-----------------------------|--------------------------------------------|
| 510(k) Number | K013230 | K011394 | K062695 |
| Decision Date | 10/25/2001 | 06/29/2001 | 10/20/2006 |
| Decision | Substantially
Equivalent | Substantially
Equivalent | Substantially
Equivalent |
| Product Code | EIH | EIH | EIH |
| Regulation Number | 872.6660 | 872.6660 | 872.6660 |
Device Description
ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height).
ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.
Indications for Use
The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Technological Characteristics and Substantial Equivalence
ZIROX and predicate devices are identical in intended use and material. Therewith, ZIROX and predicate devices are biocompatible and have similar biomechanical strength and properties.
Based on the discussion above, ZENCERA, INC. believes that ZIROX is substantially equivalent in comparison with predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized emblem, which includes an abstract representation of a human figure.
:
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Sanho Hyun Assistant Manager Zencera, Incorporated Ace Techno Tower 5th, Room 1108 197-22 Guro-3Dong, Guro-Gu Seoul 152766 REPUBLIC OF KOREA
OCT 22 2009
Re: K092630
Trade/Device Name: ZIROX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use 7Regulatory Class: II Product Code: EIH Dated: August 13, 2009 Received: August 27, 2009
Dear Mr. Hyun:
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 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 - Mr. Hyun
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Susan Runner, D.D.S., M.A. Acting 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): Device Name: ZIROX Indications for Use:
The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Hurley for WSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 092630