AADVA ZR COLORING LIQUID

K092020 · GC America, Inc. · EIH · Sep 29, 2009 · Dental

Device Facts

• Record ID: K092020
• Device Name: AADVA ZR COLORING LIQUID
• Applicant: GC America, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.

Device Story

Aadva Zr Coloring Liquid is a dental laboratory product used to color milled porcelain (zirconia) substructures. The liquid is applied to the substructure prior to the sintering process to achieve desired aesthetic shades. It is intended for use by dental technicians in a laboratory setting. The device does not involve electronic processing, software, or automated decision-making; it is a chemical coloring agent used to modify the appearance of dental restorations before final heat treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Liquid coloring agent for dental porcelain substructures. Chemical composition designed for infiltration into milled zirconia frameworks prior to sintering. No electronic, software, or mechanical components.

Indications for Use

Indicated for the complete or partial coloration of milled porcelain substructures prior to the sintering process in dental laboratory applications.

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

• Vita In-Ceram YZ for InLab (K022996)
• LAVA(TM) FRAME SHADE (K011394)

Submission Summary (Full Text)

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SEP 2 9 2009

K092020

### Section 6 - 510(k) Summary

## 510(k) Summary for Aadva Žr Coloring Liquid

#### Submitter Information:

GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

| Contact Person: | Mark Heiss, D.D.S. |
|-----------------|--------------------|
| Phone: | [phone] |
| Fax: | [phone] |

June 12, 2009 Date Prepared:

#### Device Name:

| Proprietary Name: | Aadva Zr Coloring Liquid |
|------------------------|--------------------------|
| Classification Name: | Porcelain Powder |
| Device Classification: | Class II, 872.6660 |
| Produce Code: | ElH |

#### Predicate Devices:

| Company | Device | K Number | Date Cleared |
|-----------------|----------------------------|----------|--------------|
| Vita Zahnfabrik | Vita In-Ceram YZ for InLab | K022996 | 10/9/02 |
| 3M ESPE | LAVA(TM) FRAME SHADE | K011394 | 6/29/01 |

### Description of Device:

Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled substructures before sintering. Aadva Zr Coloring Liquid is available in 8 shades.

#### Indications for use:

Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering

#### Substantial Equivalence:

The applicant device is substantially equivalent to the predicate devices in its intended use.

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# SEP 2 9 2009

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

Mark Heiss, D. D. S. . Director of New Business Development and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K092020

Trade/Device Name: Aadva Zr Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 29, 2009 Received: July 6, 2009

Dear Dr. Heiss:

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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. If 1 addition, FDA may publish further announcements concerning your device in the F deral Register.

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Page 2- Dr. Heiss

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 electronic 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/ucm115809.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

fo

Susan Runner, D.D.S., M.A. Acting 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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Section 5 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K092020

Device Name: Aadva Zr Coloring Liquid

I indications for Use: Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.

Prescription Use V (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 Device Evaluation (ODE)

Kei Hauley for MSR

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

510(k) Number: K092020

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