(43 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use describes a traditional dental restoration.
No
The device is a restoration (bonded crown and bridge restoration), which is used to restore the function or appearance of teeth. While it contributes to oral health, it does not actively treat a disease or condition in a therapeutic manner.
No
Explanation: The "Intended Use / Indications for Use" describes the device as a "Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration," which is a restorative material used for treatment, not for diagnosing medical conditions.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device's description and how it achieves its intended use. Without a device description, it's impossible to determine if it's software-only or involves hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration." This describes a dental restoration, which is a medical device used in vivo (within the body) to repair or replace damaged teeth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or calibrators.
IVDs are devices used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration
Product codes
EIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 SEP
Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K982616 Trade Name: IPS Empress® 2 Regulatory Class: II Product Code: EIH Dated: July 25, 1998 Received: July 27, 1998
Dear Mr. Mancuso:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Mancuso
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Autman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1
510(k) Number (if known): K 982616
Device Name: IPS Empress 2
Indications For Use:
Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Rann
ision Sion-Off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number