(85 days)
Not Found
No
The 510(k) summary describes a coloring liquid for dental substructures and contains no mention of AI or ML technology.
No
The device is a coloring liquid for porcelain substructures used in dentistry, not a device intended for treating or diagnosing medical conditions.
No
Explanation: The device description states it is a "liquid used for the complete or partial coloration of milled porcelain substructures before sintering." Its function is entirely related to coloring dental materials, not diagnosing a medical condition or disease.
No
The device description clearly states it is a "liquid used for the complete or partial coloration of milled porcelain substructures before sintering," indicating it is a physical substance, 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 the coloration of milled porcelain substructures before sintering. This is a process related to the fabrication of dental restorations, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces that it's a liquid used for coloring substructures.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
Product codes
EIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 9 2009
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: | (708) 897-4042 |
| Fax: | (708) 897-4031 |
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.
1
Image /page/1/Picture/0 description: The image shows a seal or logo. The logo features a stylized depiction of an eagle or bird with three wing-like extensions. The bird is positioned in the center of the seal. Encircling the bird is text, which appears to be part of the organization's name or a motto. The overall design is simple and monochromatic.
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.
2
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 (800) 638-2041 or (240) 276-3150 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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