(46 days)
Not Found
None
No
There is no mention of AI, ML, or related concepts in the provided 510(k) summary. The summary is largely empty and does not describe the device's technology.
No
There is no information in the provided text to determine if this device is a therapeutic device. The "INDICATIONS FOR USE" section is explicitly marked as "Not Found" and the "Predicate Device(s)" section does not list any specific therapeutic devices or their functions.
No
The provided text only mentions "legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976" as the "Predicate Device(s)". Without information in "INDICATIONS FOR USE" or "Device Description", it is impossible to determine if the device is intended for diagnostic purposes.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the provided information, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "INDICATIONS FOR USE" section is "Not Found". This is the primary place where the intended use of a device is described, and for an IVD, it would typically specify that the device is intended for use on specimens derived from the human body to provide information for diagnostic purposes.
- The "Device Description" is "Not Found". A description of the device's function and how it interacts with samples would be crucial for identifying it as an IVD.
- There is no mention of processing biological samples or providing diagnostic information from those samples.
While the information provided is very limited, the lack of any indication of in vitro use or diagnostic purpose makes it impossible to classify it as an IVD.
To determine if it's an IVD, you would need to find information that describes:
- What the device does.
- What kind of samples it uses (e.g., blood, urine, tissue).
- What kind of information it provides (e.g., measurements, detection of substances, identification of conditions).
- How that information is used for diagnostic purposes.
N/A
Intended Use / Indications for Use
Not Found
Product codes
EMA
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1098
Mr. John Discko Executive Vice President Centrix, Incorporated 770 River Road Shelton, Court 06484-5458
K982665 Re : Trade Name: Jumbo Silver-Reinforced Glass Ionomer Regulatory Class: II Product Code: EMA Dated: July 21, 1998 Received: July 24, 1998
Dear Mr. Discko:
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, Drug, 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 against 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. A 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 Drug 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Discko
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 regulation (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. Butman 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
K982.665
Paqe
of
Dist Kasysysl 510 (k) NUMBER (IF KNOWN) : Silver Kein DEVICE NAME: INDICATIONS FOR USE:
alass MA one
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
NAN (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
OR
Over - The - Counter - Use (Optional Format 1-2-96)