ZENOSTAR MAGIC GLAZE

K103494 · Wieland Dental + Technik GmbH & Co. KG · EIH · Feb 16, 2011 · Dental

Device Facts

• Record ID: K103494
• Device Name: ZENOSTAR MAGIC GLAZE
• Applicant: Wieland Dental + Technik GmbH & Co. KG
• Product Code: EIH · Dental
• Decision Date: Feb 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Indications for Use

The spray glaze ZENOSTAR Magic Glaze is a ready to use and easy to apply, spray on ceramic glaze, which is primarily intended for ZENOSTAR Zr restorations, manufactured with the help of the ZENOTEC Systems. However, veneered zirconium oxide restorations, (ZIROX and ZENOFLEX dimension) and metal ceramic restorations (REFLEX and REFLEX dimension) can also be glazed with the spray glaze ZENOSTAR Magic Glaze. ZENOSTAR Magic Glaze spray glaze can be used together with and/or at the same time as the relevant specific ceramic stains.

Device Story

ZENOSTAR Magic Glaze is an aerosolized dental porcelain (glass frit) used by dental technicians to glaze restorations (crowns/bridges). Applied via spray to milled zirconium dioxide, porcelain-fused-to-metal, or all-ceramic restorations; replaces manual brush-on build-up methods. Allows for thin, even layers; can be applied over ceramic stains to match natural tooth color. Requires firing at ~900°C for 1-2 minutes in a ceramic furnace. Provides control over surface shine and optical reflection; improves production efficiency by reducing firing cycles.

Clinical Evidence

Bench testing only. Physical, biological, and chemical properties (bending strength, coefficient of thermal expansion, biocompatibility, chemical solubility) tested according to ISO 6872 and ISO 7405 standards.

Technological Characteristics

Aerosolized glass frit dental porcelain. Applied via spray. Requires thermal firing at ~900°C. Complies with ISO 6872 (dentistry-ceramic materials) and ISO 7405 (dentistry-preclinical evaluation of biocompatibility of medical devices).

Indications for Use

Indicated for dental technicians to glaze dental restorations, including ZENOSTAR Zr, veneered zirconium oxide, and metal-ceramic crowns and bridges.

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

• Nova Ceramic Spray Glaze and Tru-Paque, Opaque Porcelain (K030859)

Submission Summary (Full Text)

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K103494

FEB 16 2011

#### 510 (k) Summary 5.

This 510(k) summary provides the basic principle for determination of substantial equivalence according to 21 CFR Part 807.92.

## 1. Submitter of 510(k)

Address:

Phone: Contact person: Phone: Fax: e-mail:

Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany [phone] Dr. Gerhard Polzer [phone] [phone] [e-mail]

#### 2. Device name

ZENOSTAR Magic Glaze Trade name: Common name: Ceramic Spray Glaze Classification name: Powder, Porcelain (21 CFR 872.6660, Product code: EIH, Class II)

#### 3. Legally marketed equivalent device

Predicate device: Nova Ceramic Spray Glaze and Tru- Paque , Opaque Porcelain 510(k) number: K030859

11/02/2010 Date of Summary:

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#### 510 (k) Summary

#### 4. Description of the Device

ZENOSTAR Magic Glaze is dental porcelain, which is made of glass frit and is applied in an aerosolized form. It can be used by professional dental technicians to glaze dental porcelain -fused-to-metal as well as all-ceramic restorations, like milled zirconium dioxide crowns and bridges.

This application method decreases the production time compared to the conventional build-up methods, where glaze ceramic powder has to be mixed with suitable liquids and layered onto the restoration with a brush.

After spraying on, ZENOSTAR Magic Glaze has to be fired at about 900°C for 1-2 minutes in a ceramic furnace to achieve its final properties.

Generally, the glaze bake determines the surface finish of the ceramic veneer and thereby significantly affect the esthetical appearance of the restoration. ZENOSTAR Magic Glace allows spraying on even and very thin layers of glace material, thus providing the possibility to control shining and optical reflection of the restoration by repeating the procedure.

It can be applied on single unit or multiple unit restoration at one time, and, in addition, it can be sprayed over unfired ceramic stains and body-stains, which are often used to match the color of the patient's natural teeth. These possibilities save time of additional firing cycles and enhance the efficiency of the application of ZENOSTAR MAGIC Glaze.

#### 5. Intended Use of the Device

ZENOSTAR Magic Glaze is intended to be used by dental technicians for glazing dental restorations like crowns and bridges. Although primary intended to be used for milled zirconium dioxide restorations, it can also be applied to porcelain-fused-tometal and to veneered all-ceramic restorations, if their veneering ceramics are suitable with respect to their CTE, e.g. Reflex ceramic or Zirox ceramic of Wieland Dental + Technik.

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#### 510 (k) Summary

better than the predicate device.

## 6. Comparison with the predicate device

ZENOSTAR Magic Glaze is substantially equivalent to the medical device Nova Ceramic Spray Glaze.

ZENOSTAR Magic Glaze as well as "Nova Ceramic Spray Glaze" is dental porcelain, which is made of glass frit and has to be applied in aerosolized form. Both have similar indications for use, in which they are intended to be used by professional dental technicians to glaze dental restorations, like crowns and bridges. Physical, biological and chemical properties of the bending strength, coefficient of thermal expansion, biocompatibility, and chemical solubility were tested according to international accepted standards, e.g. ISO 6872, ISO 7405, and meet their demands, respectively, and indicate high safety and effectiveness. Considering these excellent material properties and the numerous similarities as well as the lack of any significant differences between both devices, it can be concluded, that ZENOSTAR Magic Glaze is as safe, as effective, and performs as well as or

Page 5-3

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Gerhard Polzer, Ph.D. Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY

FEB 16 201

Re: K103494

Trade/Device Name: ZENOSTAR Magic Glaze Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 23, 2010 Received: November 29, 2010

Dear Dr. Polzer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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#### Page 2 - Dr. Polzer

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O. munk

Anthony D. Watson, B.S., M.S., M.B.A. 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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# 21.8. Indication for use statement

**Indications for Use**

510(k) Number (if known): K103494

Device Name: ZENOSTAR Magic Glaze

Indications for Use:

The spray glaze ZENOSTAR Magic Glaze is a ready to use and easy to apply, spray on ceramic glaze, which is primarily intended for ZENOSTAR Zr restorations, manufactured with the help of the ZENOTEC Systems. However, veneered zirconium oxide restorations, (ZIROX and ZENOFLEX dimension) and metal ceramic restorations (REFLEX and REFLEX dimension) can also be glazed with the spray glaze ZENOSTAR Magic Glaze. ZENOSTAR Magic Glaze spray glaze can be used together with and/or at the same time as the relevant specific ceramic stains.

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 OF NEEDED)

Concurrence of CDRH, Office of Dexiges to fathlation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103494

(Posted November 13, 2003)