(10 days)
Not Found
No
The device description and intended use clearly state that the device is a porcelain powder for coloring zirconia restorations. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a coloring agent for zirconia dental restorations, not a device used to treat or prevent disease. Its primary function is aesthetic.
No
Explanation: The device, "Heisenberg Effect Shades," is described as a coloring agent for zirconia frameworks and restorations, classified as "Porcelain powder for clinical use." Its purpose is cosmetic/restorative (coloring), not to diagnose a disease or condition. It undergoes biocompatibility testing, not performance studies common to diagnostic devices.
No
The device is described as "Porcelain powder for clinical use" and is used for coloring zirconia frameworks and restorations, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for coloring zirconia frameworks and restorations for teeth. This is a dental material used in the fabrication of prosthetics, not for testing samples from the human body to diagnose or monitor a medical condition.
- Device Description: It is classified as "Porcelain powder for clinical use," which aligns with dental materials, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device clearly falls outside of that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
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, |
| Regulatory Affairs Specialist | |
| Phone: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| 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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3
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 (800) 638-2041 or (301) 796-7100 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
Page 1 of _1
510(k) Number:
510(k) Submission: Heisenberg Effect Shades
November 23, 2011
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