(5 days)
Not Found
No
The description focuses on the material and manufacturing process (CAD/CAM milling) of a dental restoration substructure, with no mention of AI or ML.
No.
The device is a ceramic block used to create dental restorations (crowns and bridges) and does not directly provide therapy or treatment to a patient.
No
This device is a ceramic block used to fabricate dental restorations (crowns and bridges), not to diagnose a condition or disease. It is a material used in the manufacturing process of a medical device, not a diagnostic tool itself.
No
The device is a physical ceramic block used in a CAD/CAM milling process, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a ceramic block used to create dental restorations (crowns and bridges). It is a material used in the manufacturing process of a medical device that is implanted or placed in the mouth.
- Intended Use: The intended use is as a "substructure for Porcelain fused to ceramic fixed dental restorations." This is a structural component for a dental prosthesis, not a diagnostic test performed on a biological sample.
- Device Description: The description details the material (Zirconia Oxide) and the manufacturing process (CAD/CAM milling and firing). This aligns with a material used in dental fabrication, not a diagnostic assay.
Therefore, this device falls under the category of a dental material or component used in the creation of a medical device (the dental restoration), rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined at the user facility using CAD/CAM technology.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There is a metal chuck glued on the end of the block that holds the block into the CAD/CAM machine. The block is milled into cores for teeth and then is fired in an oven to harden the ZrO2. Then the core is layered with ceramic porcelain to make a finished tooth.
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
user facility
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
SECTION 5. 510(K) SUMMARY OR 510(K) STATEMENT
| Submission
Correspondent: | Emergo Group, Inc.
2519 McMullen Booth Road
Suite 510-295
Clearwater, Florida 33761
Phone: (727) 797-4727
Fax: (727) 797-4757
Email: igordon@emergogroup.com
Contact: Ian P. Gordon
Sr. Vice President | AUG 2 1 2006 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submission Sponsor: | Foundation Milling Center (FMC)
235 Aero Drive
Buffalo, NY 14225
Phone: (716) 838-3838
Fax: (716) 839-8004
Email: jacob_oppenheimer@yahoo.com
Contact: Jacob Oppenheimer
Vice President, Product Development | |
| Date summary prepared: | May 31, 2006 | |
| Device trade name: | Foundation Milling Center Z-Blocks | |
| Device common name: | Z-Blocks | |
| Device classification name: | Porcelain Powder for Clinical Use | |
| Legally marketed devices
to which the device is
substantially equivalent: | K051705, IPS E. MAX CAED/IPS E.MAX ZIRCAD, Ivoclar Vivadent, Inc. | |
| Description of the device: | This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There
is a metal chuck glued on the end of the block that holds the block into the
CAD/CAM machine. The block is milled into cores for teeth and then is
fired in an oven to harden the ZrO2. Then the core is layered with ceramic
porcelain to make a finished tooth. | |
| Intended use of the device: | This product is indicated for use as a substructure for porcelain fused to
ceramic fixed dental restorations; namely crowns and bridges. Foundation
Milling Center Z-Blocks are machined at the user facility using CAD/CAM
technology. | |
| Technological
characteristics: | The technological characteristics between the predicate and proposed
devices are identical. There is no difference in fundamental scientific
technology. They are made from the same materials and have the same
intended use. | |
| Conclusions: | By definition, a device is substantially equivalent when the device has the
same intended use and the same technological characteristics as the
predicate device.
There are no significant differences between the Foundation Milling Center
Z-Blocks and the predicate devices and therefore, the Foundation Milling
Center Z-Blocks to not raise any questions regarding safety and
effectiveness.
The Foundation Milling Center Z-Blocks, as designed, are as safe and
effective as the predicate device, and the device is determined to be
substantially equivalent to the referenced predicate devices currently on
the market. | |
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of a stylized eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
Foundation Milling Centre C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K062389
Trade/Device Name: Z-Block 20/19, Z-Block 40/19, Z-Block 55/19 Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 15, 2006 Received: August 16, 2006
Dear Mr. Lehtonen:
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 such 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 Eederal Register.
3
ﻧﺴﺮ
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be actived that 1 Da determination that your device complies with other requirements mount that I Driving may Federal statutes and regulations administered by other Federal agencies. or the Act of all , vath all the Act's requirements, including, but not limited to: registration r ou intest compry was 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 ce real of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms fotor wiffication. The FDA finding of substantial equivalence of your device to a premainer notification - Fedicate 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), 11 you dome of 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 maj Secure 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/industry/support/index.html.
Sincerely yours,
Shi-Jie Li, Ph.D.
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
SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Z-Block 20/19, Ż-Block 40/19, Z-Block 55/19
Indications for Use:
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
.. Ja CHI) in of Anasihesiology, General Hospital, an Cuntral, Dental Devic
: Number.
Foundation Milling Center