(80 days)
Not Found
Not Found
No
The summary describes a physical implant device made of titanium and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used during endodontic therapy to permanently fill the root canal of a tooth, which is a therapeutic intervention.
No
The device is used to fill a tooth's root canal during endodontic therapy, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a physical titanium endodontic point, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fill permanently the root canal of a tooth" during endodontic therapy. This is a therapeutic procedure performed directly on the patient's tooth.
- Device Description: The device is a physical implant made of titanium, designed to be placed within the body (the root canal).
- Lack of Diagnostic Function: There is no mention of this device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition. IVDs are used for diagnostic purposes, not for direct treatment or implantation.
Therefore, the Pacific Implant Titanium Endodontic Point is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.
Product codes
EKL
Device Description
The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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
§ 872.3840 Endodontic silver point.
(a)
Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.(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
Kaa255d
OCT 21 1999
EXHIBIT 6
510(k) Summary
Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036
On behalf of Pacific Implant Inc. 510(k) Submission: Pacific Implant Titanium Endodontic Point July 30, 1999
The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.
This product is for use only by dentists; it is not intended for OTC use. It is substantially equivalent to various marketed silver endodontic points, including those marketed by Pulpdent Corporation.
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three parallel lines that curve and flow together, resembling a human figure or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Pacific Implant Inc. c/o Mr. Daniel J. Manelli Farkas & Manelli PLLC Attorneys 2000 M Street N.W., 7th Floor Washington, D.C. 20036-3307
K992582 Re: Pacific Implant Titanium Endodontic Point Trade Name: Regulatory Class: I Product Code: EKL Dated: July 30, 1999 Received: August 2, 1999
Dear Mr. Manelli:
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, Druq, 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Mr. Manelli:
obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation che not rer acions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as firstibed in your 510 (k) premarket notification. The FDA debtired in four and equivalence of your device to a legally marketed predicate device results in a classification for your marketed predice and thus, 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 rigar diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreated advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the orrios or compitied, "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,
Timothy A. Ulatowski
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT 4
Page _ 1
510(k) Number (if known):
Device Name: Pacific Implant Titanium Endodontic Point
Indications For Use:
The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.
(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)
OR
Over-The-Counter Use
Suser Quinor
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Q 510(k) Number _