HEISENBERG EFFECT SHADES

K120011 · 3M Espe AG · EIH · Jan 13, 2012 · Dental

Device Facts

• Record ID: K120011
• Device Name: HEISENBERG EFFECT SHADES
• Applicant: 3M Espe AG
• Product Code: EIH · Dental
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.

Device Story

Heisenberg Effect Shades are porcelain powders used for the intensive coloring/characterization of zirconia dental restorations. The device is applied to zirconia frameworks or monolithic restorations after initial treatment with Heisenberg Dyeing Liquids. Used in dental clinical settings by dental professionals to achieve specific aesthetic color effects on anterior and posterior teeth. The device functions as a coloring agent to enhance the final appearance of the restoration. Benefits include improved aesthetic customization of dental prosthetics.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility assessment performed using standard risk assessment techniques and FDA/international guidelines.

Technological Characteristics

Porcelain powder for clinical use (21 CFR 872.6660). Material composition and physical/mechanical properties are consistent with predicate zirconia coloring agents. Product is available in various colors for application to zirconia frameworks.

Indications for Use

Indicated for intensive coloring of zirconia frameworks and all-zirconia monolithic restorations for anterior and posterior teeth, following basic dyeing with Heisenberg Dyeing Liquids.

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

• Lava™ Frame Shade by 3M ESPE (K011394)
• Zenostar Color Zr by Wieland Dental + Technik GmbH & Co. KG (K112710)

Submission Summary (Full Text)

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3M ESPE AG

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JAN 1 3 2012 1.6 510(k) Summary of Safety and Effectiveness

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter

| Company: | 3M ESPE AG |
|-----------------------------------|---------------------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,<br>Regulatory Affairs Specialist |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date: | November 23, 2011 |

## Name of Device

| Proprietary Name: | Heisenberg Effect Shades |
|----------------------|-----------------------------------|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | Effect shade |

#### Predicate Devices

Lava™ Frame Shade by 3M ESPE, Germany ........................................................................................................................................ Zenostar Color Zr by Wieland Dental + Technik GmbH & Co. KG, Germany... K112710

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## Description for the Premarket Notification

Heisenberg Effect Shade is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660).

Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth restorations after basic dyeing using Heisenberg Dyeing Liquids.

Heisenberg Effect Shades will be available in various colors.

Predicate devices to which Heisenberg Effect Shades have been compared are Lava™ Frame Shades by 3M ESPE, Germany (K011394) and Zenostar Color Zr by Wieland Dental + Technik, Germany (K112710). As Heisenberg Effect Shades, both predicate devices are suited to be used for coloring of zirconia restorations. Lava™ Frame Shades are suited to be used for the shading of zirconia frameworks and all-zirconia, monolithic restorations (made from Lava™ Frame zirconia mill blanks by 3M ESPE, K011394) for anterior and posterior teeth. As Heisenberg Effect Shades, Zenostar Color Zr Effect Shades are to be used for individual characterization of zirconia restorations.

In this 510(k) premarket notification Heisenberg Effect Shades have been compared to its predicate devices with regard to indications for use, physical and mechanical properties (data from bench testing), and chemical composition. The comparison for indications for use, performance data, and chemistry shows that Heisenberg Effect Shades are substantially equivalent to the predicate devices: Lava™ Frame Shades by 3M ESPE, Germany (K011394) and Zenostar Color Zr by Wieland Dental + Technik, Germany (K112710).

Biocompatibility testing was carried out. A biocompatibility assessment was developed for Heisenberg Effect Shades using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Heisenberg Effect Shades are safe for its intended use.

In summary, it can be concluded that Heisenberg Effect Shades are as safe and effective as the predicate devices Lava™ Frame Shades by 3M ESPE, Germany (K011394) and Zenostar Color Zr by Wieland Dental + Technik, Germany (K112710).

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## Indications for Use:

Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

3M ESPE AG C/O Mr. Norbert Stuiber TUV SUD America Incorporated 1755 Old Highway 8 NW New Brighton, Minnesota 55112

JAN 1 3 2012

Re: K120011

Trade/Device Name: Heisenberg Effect Shades Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 28, 2011 Received: January 3, 2012

Dear Mr. Stuiber:

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 - Mr. Stuiber

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/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.

Wh for

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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# Indications for Use

| 510(k) Number (if known): | K12001 |
|---------------------------|--------|
|---------------------------|--------|

Device Name:

Heisenberg Effect Shades are suited for more intensive coloring of Indications For Use: Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.

Heisenberg Effect Shades

X Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence/of OPRH, Office of Device Evaluation (ODE)

Susan Kunzer

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

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510(k) Number:

510(k) Submission: Heisenberg Effect Shades

November 23, 2011

Page 13of 306

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