(88 days)
Not Found
No
The description focuses on the material composition and physical properties of a dental blank used in CAD/CAM fabrication, with no mention of AI or ML technology.
No
The device is a dental blank for fabricating restorations, not a therapeutic device directly treating a condition.
No
Explanation: The Zmatch® Block is a pre-formed machineable dental blank used for the CAD/CAM fabrication of dental restorations. It is a material used in the manufacturing process, not a device that diagnoses conditions or diseases.
No
The device description clearly states that the Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide, which is a physical material, not software.
Based on the provided information, the Zmatch® Block is not an In Vitro Diagnostic (IVD) device.
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 a medical device (the dental restoration), not a diagnostic test performed on a biological sample.
- Device Description: The device is a pre-formed machineable dental blank made of zirconium oxide. It's a material used to create a final product, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. It's purely a material for creating a physical restoration.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Zmatch® Block does not fit this description.
N/A
Intended Use / Indications for Use
The Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations. The Zmatch® Block 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
Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition
Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block 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
JAN 2 6 2009
510(k) SUMMARY
Submitter
| Name | Dentaim Co ,Ltd |
|---|---|
| Address | Room No 401, ACE techno Tower 1st, 197-17, Guro-Dong, |
| Guro-Gu, Seoul, Korea |
US Agent:
| Name | Won Chul Lee |
|---|---|
| Address | 1352 Amberlea Dr E , Gahanna Ohio 43230 U S A |
| Phone No | 614-444-0660 |
| wonchullee@hotmail.com |
Official Correspondent:
| Name | Daesuck Chun |
|---|---|
| Address | Room No 401, ACE techno Tower 1st, 197-17, Guro-Dong, |
| Guro-Gu, Seoul, Korea | |
| Phone No | +82-2-2109-6380 |
| Fax No | +82-2-2109-6389 |
| hi2chun@hanmail.net |
Device Identification
1
| Proprietary Name | Zmatch® Block |
|---|---|
| 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
| Device Name | Sagemax
Bioceramics-
Sagemax Z-Blank | Dentsply-Cercon
Base | 3M-LAVA
Zirconia |
|---------------|--------------------------------------------|-------------------------|---------------------|
| 510(k) Number | K062695 | K013230 | K11394 |
1
| אין אין
| / | |
|---|---|
| / |
1
1
1 | |
| Decision Date | 10/20/2006 | 10/25/2001 | 06/29/2001 |
|---|---|---|---|
| Decision | Substantially | ||
| Equivalent | Substantially | ||
| Equivalent | Substantially | ||
| Equivalent | |||
| Product Code | EIH | EIH | EIH |
| Regulation Number | 872 6660 | 872 6660 | 872 6660 |
Device Description
Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition
Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block 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 Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations The Zmatch® Block is used for the manufacturing of inlays, onlays, veneers, crowns and bridges
Technological Characteristics and Substantial Equivalence
Zmatch® block and predicate devices are identical in intended use and material Therewith, Zmatch® block and predicate devices are biocompatible and have similar biomechanical strength and properties
Based on the discussion above, Dentaim Co ,Ltd believes that Zmatch® block is substantially equivalent in comparison with predicate devices
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr Daesuck Chun Manager Dentam Company, Lımıted Room No 401, ACE Techno Tower 1st 197-17, Guro-Dong, Guro-Gu Seoul, Korea
JAN 2 6 2009
Re K083201
Trade/Device Name Zmatch® Block Regulation Number 872 6660 Regulation Name Porcelain Powder for Clinical Use Regulatory Class II Product Code EIH Dated October 28, 2008 Received October 30, 2008
Dear Mr Chun
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 ındıcations 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 such additional controls Existing major regulations affectung 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 Chun
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 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.
Anthony D a whom for
Ginette Y Michaud, M D
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
K083201 510(k) Number (if known): Zmatch® Block Device Name: Indications for Use:
The Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations. The Zmatch® Block is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Prescription Use _ V (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)
Suce-Rurnes
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083201