(73 days)
Not Found
No
The device is a dental ceramic material used in a CAD/CAM process, with no mention of AI/ML in its description or intended use.
No
The device is a dental ceramic used to fabricate restorations (substructures for crowns and bridges), which replace missing tooth structure. It does not actively treat a disease or condition.
No
This device is a dental ceramic used for fabricating dental restorations, not for diagnosing conditions.
No
The device description clearly states that Xavex G100 is a dental ceramic material, a physical substance used to fabricate restorations. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Xavex G100's Use: Xavex G100 is a dental ceramic used by dental technicians to fabricate dental restorations (like crowns and bridges). It is a material that is shaped and processed to be placed in the mouth, not used to test samples from the body.
- Intended Use/Indications for Use: The description clearly states its use is for manufacturing dental restorations for patients.
- Device Description: The description focuses on the material composition and how it is used to create dental appliances.
There is no indication in the provided text that Xavex G100 is used to analyze biological samples or provide diagnostic information.
N/A
Intended Use / Indications for Use
Xavex G100 is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations. It is a partially sintered yttria stabilized zirconium oxide powder that has to be machined with the CAD/CAM technique to its required shape and then sintered to full density.
Xavex G100 is recommended for manufacturing substructures of single tooth and bridgework with up to two pontics, which can be used in the anterior as well as in the posterior tooth region.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Xavex G100 is a dental ceramic that is composed of partially sintered yttria (yttrium oxide) stabilized zirconium oxide.
Xavex G100 is designed for manufacturing substructures of all-ceramic dental appliances for the sole use of particular patients. It has to be machined with the CAD/CAM technique and then sintered to its full density.
Xavex G100 is designed for use as single tooth or bridgeworks with up to two pontics in the anterior as well as the posterior teeth region.
Xavex G100 is biocompatible and insoluble in water. In addition, the strength of densely sintered Zirconium oxide is extremely high and makes delicate and filigree framework shaping possible. This, together with the white color of the zirconium oxide offers the basis for aesthetically pleasing, safe and effective dental restorations.
Xavex G100 substructures can be veneered with suitable dental porcelains with the layering technique.
Xavex G100 meets all applicable requirements of the standard ISO 6872: 1997 "Dental ceramic".
The partially sintered Xavex G100 blanks will be offered as disks with a diameter of 100 mm and 5 different thicknesses:
Xavex G100-25 with a thickness of 25 mm
Xavex G100-20 with a thickness of 20 mm
Xavex G100-18 with a thickness of 18 mm
Xavex G100-14 with a thickness of 14 mm
Xavex G100-10 with a thickness of 10 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior as well as the posterior teeth region
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): 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
Premarket Notification 510 (k) Xavex G100
Image /page/0/Picture/1 description: The image shows a date, JUN 23 2005. The text is in a bold, sans-serif font. The date is likely extracted from a document or photograph, indicating the date of creation or relevance of the content.
Image /page/0/Picture/2 description: The image shows the word "WIELAND" in large, bold, black letters. Below the word "WIELAND" is the phrase "Dental + Technik" in a smaller, lighter font. The text is horizontally aligned and centered.
Wieland Dental + Technik Gmbel & Co. KG Schwerninger Straße 13 3-751-49 Pressure Размасы 16.2014 1. 154,9008. 2000: 6年度 2017年8月 sept. 2011 as 1998
6050903
5. 510 (k) Summary
Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
2005-04-07 Date of Summary:
Trade name:
Xavex G100
Classification name: Product code: C.D.R section: Classification:
Porcelain powder for clinical use ElH 872.6660 Class II
Legally marketed Cercon Base equivalent device:
K013230 510(k) number:
1
Premarket Notification 510 (k) Xavex G100
Image /page/1/Picture/1 description: The image shows the logo for WIELAND Dental + Technik. The word "WIELAND" is in large, bold, black letters. Below that, in smaller letters, are the words "Dental + Technik."
Wieland Sental - "Ashink GIMBH & Co Schwomenner Microped S : 75, 为何: 31mm Doctforlo in 0-75170 95 Child
510 (k) Summary
Device description
Xavex G100 is a dental ceramic that is composed of partially sintered yttria (yttrium oxide) stabilized zirconium oxide.
Xavex G100 is designed for manufacturing substructures of all-ceramic dental appliances for the sole use of particular patients. It has to be machined with the CAD/CAM technique and then sintered to its full density.
Xavex G100 is designed for use as single tooth or bridgeworks with up to two pontics in the anterior as well as the posterior teeth region.
Xavex G100 is biocompatible and insoluble in water. In addition, the strength of densely sintered Zirconium oxide is extremely high and makes delicate and filigree framework shaping possible. This, together with the white color of the zirconium oxide offers the basis for aesthetically pleasing, safe and effective dental restorations.
Xavex G100 substructures can be veneered with suitable dental porcelains with the layering technique.
Xavex G100 meets all applicable requirements of the standard ISO 6872: 1997 "Dental ceramic".
The partially sintered Xavex G100 blanks will be offered as disks with a diameter of 100 mm and 5 different thicknesses:
Xavex G100-25 with a thickness of 25 mm Xavex G100-20 with a thickness of 20 mm Xavex G100-18 with a thickness of 18 mm Xavex G100-14 with a thickness of 14 mm Xavex G100-10 with a thickness of 10 mm
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2005
Dr. Gerhard Polzer Director Regulatory Affairs Wieland Dental +Technik GmbH & Company KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K050903
Trade/Device Name: Xavex G100 Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 8, 2005 Received: April 11, 2005
Dear Mr. Polzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have ro row 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 Amendments, or to are 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 approvisions 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
Page 2 -- Mr. Polzer
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT is issualites or that your device complies with other requirements meall that IDA has made a deceminaresulations administered by other Federal agencies. of the Act of ally receitar statutes and reguirements, including, but not limited to: registration You must comply with an the Hec b required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Part 820), and if 1 CFR Part 820); and if requirents as set form in the quality by occasions (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) This letter will anow Jour of Substantial equivalence of your device to a premarket notification. The PDF 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), II you desire specific advice for your de 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 may other general miormational and Consumer Assistance at its toll-free Drisber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cars
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
Indications for Use
510(k) Number (if known):
Xavex G100 Device Name:
Indications For Use:
Xavex G100 is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations. It is a partially sintered yttria stabilized zirconium oxide powder that has to be machined with the CAD/CAM technique to its required shape and then sintered to full density.
Xavex G100 is recommended for manufacturing substructures of single tooth and bridgework with up to two pontics, which can be used in the anterior as well as in the posterior tooth region.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rurr
(Division Sign-Off)
ﻠﺴﻌ Page 1 of
person of Anesthesiology, General Hospital, information of Anesthesiology, Gene
510(k) Number: J