(114 days)
Not Found
No
The summary describes a dental block material for CAD/CAM fabrication, focusing on its composition and intended use in creating dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
No
Explanation: This device is for manufacturing dental restorations (inlays, onlays, veneers, crowns, and bridges) and is intended for use by dental technicians. It is a material for fabrication, not a device applied directly to a patient for therapeutic purposes.
No
Explanation: The device is a dental block used for manufacturing dental prostheses (inlays, onlays, veneers, crowns, and bridges) via CAD/CAM fabrication. It does not perform any diagnostic function.
No
The device description clearly states it is a "Dental Porcelain Zr Dental block" composed of various materials, indicating it is a physical material used for fabrication, 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 for the fabrication of dental restorations (inlays, onlays, veneers, crowns, and bridges) using CAD/CAM technology. This is a manufacturing process for medical devices that are implanted or placed in the body.
- Device Description: The device is a block of ceramic material used by dental technicians to create these restorations. It's a raw material for manufacturing.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze human specimens.
The device is a material used in the manufacturing of dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges
Product codes
EIH
Device Description
Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.
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
dental technicians
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ams Co., Ltd.
MAR 1 2 2010
1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea (429-850) Tel: *82-31-4311751 Fax: 082-31-4021751
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information: Ams Co., Ltd. 1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea Tel: *82-31-4311751 Fax: 082-31-4021751
Date Summary Prepared: Feb 19, 2010
Contact Person: Tae Choung Son / president info@ams.bz
Device Name:
- 北京
・・・
Trade Name(s): Zr Dental block Classification Name: Porcelain Powder for Clinical Use Panel: Dental Product Code: દાન
Predicate Device Information:
K083201 Zmatch Block manufactured by Dentam Company. Limited
Device Description:
Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.
Intended Use:
Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in intended use and technological characteristics, including:
*components
*indications for use
Chemical Properties
원동이다.
- chemical properties * performance properties
Conclusions:
Based on the information provided in this premarket notification Ams Co., Ltd concludes that Zr Dental block is safe and effective and substantially equivalent to predicate device as described herein.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes above a wavy line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 2 2010
AMS Company, Limited C/O Mr. Claude Yang Chief Executive Official Onbix Corporation #708 Le-Meilleur Town, 837-19 Gangnam-Gu Seoul Republic of Korea 135-937
Re: K093571
Trade/Device Name: Zr Dental Block Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 28, 2010 Received: March 9, 2010
Dear Mr. Yang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
2
Page 2- Mr. Yang
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): j
Device Name: Zr Dental block
Indications for Use:
. 19-18'90 08
Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Part 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)
RSBetz DOS for Dr. K.P. Muly
Division Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices
; 10(k) Number: K093571
OOb