(44 days)
Not Found
Not Found
No
The summary describes a dental post for structural stabilization and build-up, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
No
The device is used for preprosthetic stabilization and build-up, which prepares the tooth for a prosthetic but does not inherently treat a disease or condition itself.
No
Explanation: The device is intended for "preprosthetic stabilization" and "preprosthetic build up," which are restorative and preparatory procedures, not diagnostic ones. It does not mention identifying or characterizing a disease or condition.
No
The summary describes a device for preprosthetic stabilization and build-up of tooth structure, which inherently involves physical materials and procedures, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for preprosthetic stabilization and build-up of tooth structure. This is a direct treatment or preparation of a patient's anatomy, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- 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.)
- Providing diagnostic information
- Using reagents or assays
The device appears to be a dental device used for restorative procedures.
N/A
Intended Use / Indications for Use
Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.
Product codes
ELR
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
tooth structure
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
Not Found
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
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 the limitations in § 872.9.
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1997
Mr. Peter P. Mancuso Regulatory/Quality Assurance Manager Inoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K972875 Trade Name: Cosmopost Requlatory Class: II Product Code: ELR Dated: July 31, 1997 Received: August 4, 1997
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 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 general controls provisions The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 miqht 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Patricia Cusimano Hor
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 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Cosmopost Device Name: _
Indications For Use:
(Per 21 CFR 801.109)
Cosmopost is intended to be used for preprosthetic stabilization of the tooth structure after endodontic treatment with largely intact crown, preprosthetic build up for damaged clinical crowns and thus resulting in loss of retention, using an indirect and direct method of attachment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Merl Shipps |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972875 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)