XAWEX G 100

K050903 · Wieland Dental + Technik GmbH & Co. KG · EIH · Jun 23, 2005 · Dental

Device Facts

• Record ID: K050903
• Device Name: XAWEX G 100
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended 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.

Device Story

Xavex G100 is a partially sintered yttria-stabilized zirconium oxide ceramic; supplied as disks of varying thicknesses. Used by dental technicians in a laboratory setting; processed via CAD/CAM machining to create dental substructures; followed by sintering to achieve full density. Finished substructures are veneered with dental porcelain. High strength and biocompatibility allow for filigree framework shaping; white color provides aesthetic restoration. Benefits include safe, effective, and aesthetically pleasing dental appliances for patients requiring single tooth or bridge restorations.

Clinical Evidence

Bench testing only. Device meets requirements of ISO 6872:1997 for dental ceramics.

Technological Characteristics

Partially sintered yttria-stabilized zirconium oxide. Supplied as 100 mm diameter disks in 10, 14, 18, 20, and 25 mm thicknesses. Complies with ISO 6872:1997. Biocompatible and water-insoluble. Requires CAD/CAM machining and subsequent sintering.

Indications for Use

Indicated for dental technicians to fabricate all-ceramic dental restorations, specifically substructures for single teeth or bridgework with up to two pontics in anterior and posterior regions.

Regulatory Classification

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.

Predicate Devices

• Cercon Base (K013230)

Submission Summary (Full Text)

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Premarket Notification 510 (k) Xavex G100

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6050903

## 5. 510 (k) Summary

Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: [phone]

| Contact person: | Dr. Gerhard Polzer |
|-----------------|----------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |

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:

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Premarket Notification 510 (k) Xavex G100

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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

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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## 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