(49 days)
Not Found
No
The summary describes a dental ceramic material used for manufacturing dental restorations via CAD/CAM or copying techniques. There is no mention of AI or ML in the device description, intended use, or any other section. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a dental ceramic material used to create substructures for dental restorations, not a therapeutic device designed to cure or treat a disease or condition.
No
The device is described as a material (Metoxit CAM-Blanks) used for manufacturing substructures for dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a dental ceramic blank, which is a physical material used in the manufacturing of dental restorations. It is 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 creating substructures for dental restorations, which are implanted in the patient's mouth. This is a therapeutic/restorative purpose, not a diagnostic one.
- Device Description: The description details a material used for manufacturing dental appliances, not for testing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide stabilized tetragonal zirconium-oxide polycrystals. Metoxit CAM-Blanks are designed for the manufacturing of substructures for all-ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining technique or the copying technique, then sintered to full density and strength and for the sole use of the particular patients. Metoxit CAM-Blanks are designed for the use as single tooth restorations or bridgeworks with up to two pontics in the anterior as well as in the posterior teeth region.
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
All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
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.
K013230, K051462, K050903, K022996, K051705, K052130, K062506, K001815
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
Image /page/0/Picture/0 description: The image shows the word "METOXIT" in a stylized, blocky font. The letters are bold and black, contrasting with the white background. The 'O' in the word is represented by a square shape.
high tech ceramics
4 1 1 - 1 - 1 - 1 - PREMARKET NOTIFICATION - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
Device
Metoxit CAM-Blanks
K072569
510 (k) Summary
007 ຊຶ່ງ 2007
| Submission
Correspondent: | Emergo Group, Inc.
1705 S. Capital of Texas Hwy
Suite 500
Austin, TX 78746 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 512-327-9997
Fax: 512-327-9998
Email: iangordon@emergogroup.com
Contact: Ian Gordon
Sr. Vice President |
| Submission Sponsor: | Metoxit AG
Emdwiesenstrasse 6
CH-8240 Thayngen |
| | Phone: +41 52 645 0101
Email: Stefan.koebel@metoxit.com
Contact: Dr. Wolfram Weber, General Manager |
| Date summary prepared: | July 31, 2007 |
| Device trade name: | Metoxit CAM-Blanks |
| Device common name: | CAM-Blanks |
| Device classification name: | Porcelain Powder for Clinical Use |
| Legally marketed devices
to which the device is
substantially equivalent: | K013230, K051462 - Cercon base
K051462 Cercon base colored
K050903 XAWEX G100
K022996 Vita YZ cubes
K051705 Ivoclar ZIRCAD
K052130 Vita AL cubes
K062506 Sirona InCoris AL
K001815 DCS DC-Zirkon |
| Description of the device: | Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide
stabilized tetragonal zirconium-oxide polycrystals.
Metoxit CAM-Blanks are designed for the manufacturing of substructures
for all-ceramic dental appliances. The dental appliance is machined either
by CAD/CAM machining technique or the copying technique, then sintered
to full density and strength and for the sole use of the particular patients.
Metoxit CAM-Blanks are designed for the use as single tooth restorations
or bridgeworks with up to two pontics in the anterior as well as in the
posterior teeth region. |
| Intended use of the device: | Metoxit blanks are indicated for use as a substructure for porcelain fused
ceramic fixed dental restorations |
| | |
| 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 Metoxit CAM - Blanks
and the predicate devices and therefore, the Metoxit CAM-Blanks do not
raise any questions regarding safety and effectiveness. |
| | The Metoxit CAM-Blanks, 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. |
1
Image /page/1/Picture/0 description: The image shows the word "METOXIT" in a stylized, blocky font. Below the word, the phrase "high tech ceramics" is written in a smaller, sans-serif font. The text is black against a white background, creating a high-contrast visual.
.
:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2007
Metoxit AG C/O Mr. Ian Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746
Re: K072569
Trade/Device Name: Metoxit CAM-Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 6, 2007 Received: September 12, 2007
Dear Mr. Gordon:
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 Federal Register.
3
Page 2- Mr. Gordon
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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Nusf R.S. Ogle
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
510(k) PREMARKET NOTIFICATION
Indications for Use State
510(k) Number:
- 1564
Indications for Use:
Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1.
| Table 1: Indications of use and maximum number of pontics. | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | . | Comments of the program and the comments of lines and the bearing |
| Process chain | Material | Single unit crowns | Bridges, number of pontics | ||
|---|---|---|---|---|---|
| Anterior | Posterior | Anterior | Posterior | ||
| Porous blank is | |||||
| machined to | |||||
| enlarged | |||||
| framework, then | |||||
| sintered and | |||||
| veneered. | TZP-A | X | X | 2 | 2 |
| Al-999 | X | X | 1 | - | |
| Dense blank is | |||||
| machined to | |||||
| net-shape | |||||
| framework, then | |||||
| veneered. | TZP | X | X | 2 | 2 |
| TZP-A | X | X | 2 | 2 |
X indicated; - not indicated; digits show maximum number of pontics.
All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Prescription Use AND/OR 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Runse
on Sign-Off) ion of Anesthesiology, General Hospital, John Control, Dental De