(9 days)
Not Found
No
The device description and performance studies focus on the chemical composition and shading properties of a dyeing liquid for dental restorations, with no mention of AI or ML.
No.
The device description clearly states it is "Porcelain powder for clinical use" intended for 'shading' dental restorations, not for treating or preventing a medical condition.
No
The device description clearly states its intended use is "for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth." This indicates a cosmetic or restorative purpose, not a diagnostic one. There is no mention of identifying, diagnosing, or monitoring a disease or condition.
No
The device is a dyeing liquid, which is a physical substance used for shading dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth." This describes a process for coloring dental prosthetics, not for diagnosing a disease or condition based on in vitro examination of specimens derived from the human body.
- Device Description: The device is classified as "Porcelain powder for clinical use (21 C.F.R. § 872.6660)". This classification falls under dental devices, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for use in the fabrication of dental restorations, which is a therapeutic or restorative process, not a diagnostic one.
N/A
Intended Use / Indications for Use
Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restora- tions for anterior and posterior teeth.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth. Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.
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)
The device was compared to its predicate device with regard to chemical composition, indications for use, and physical and mechanical properties (e.g. chemical solubility, strength, remission). Biocompatibility testing was carried out. The comparison for chemistry, indications for use, and performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device.
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
KIIIa57
MAY 1 3 2011
1
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: | April 15, 2011 |
Name of Device
| Proprietary Name: | Heisenberg Dyeing Liquids |
|---|---|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | Dyeing liquid |
Predicate Device
Lava Frame Shade by 3M ESPE, Germany..........................................................................................................................................
1
Description for the Premarket Notification
Heisenberg Dyeing Liquid is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660).
Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.
Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.
Predicate device to which Heisenberg Dyeing Liquids have been compared is Lava Frame Shade by 3M ESPE (K011394). Lava Frame Shade is suited to be used for the shading of zirconia frameworks and all-zirconia, monolithic restorations (made from Lava Mill Blanks by 3M ESPE, K011394) for anterior and posterior teeth. The difference to the predicate device is primary in the change of coloring ions and secondary in the change of the general chemistry.
In this 510(k) premarket notification Heisenberg Dyeing Liquids have been compared to its predicate device with regard to chemical composition, indications for use, and physical and mechanical properties (e.g. chemical solubility, strength, remission). The comparison for chemistry, indications for use, and performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device: Lava Frame Shade by 3M ESPE, Germany (K011394).
Biocompatibility testing was carried out.
In summary, it can be concluded that Heisenberg Dyeing Liquids are as safe and effective as the predicate device Lava Frame Shade by 3M ESPE, Germany (K011394).
Indications for Use:
Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with three lines representing its wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
3M Espe AG C/O Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K111257
Trade/Device Name: Heisenberg Dyeing Liquids Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: April 29, 2011 Received: May 4, 2011
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.
3
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,
Nh 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
4
Indications for Use
| 510(k) Number (if known): | K111257 |
|---|---|
| Device Name: | Heisenberg Dyeing Liquids |
| Indications For Use: | Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restora- tions for anterior and posterior teeth. |
X Prescription Use (Part:21 CFR 801 Subpart Dị
: ·
AND/OR
Over-The-Counter Use _ (21 CFR 501 Subpart Cị
iplease do not write below this line-continue on another Page if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Susan Turner
Division Sign-Off) nvision of Anesthesiology, General Hospital tiection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
›10(k) Number: _