(79 days)
The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.
The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).
The provided text describes a 510(k) Premarket Notification for the Foremost Fiber-Metal Post, a root canal post. It does not pertain to an AI/ML powered medical device, therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue cycle strength for finished restoration (cyclic loading test - occlusal and lateral loading) | "The results of this test demonstrated that the Foremost Fiber-Metal Post, when used as directed in the device labeling, results in an acceptable fatigue cycle strength for the finished restoration." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance testing for the Fiber-Metal Posts consisted of a cyclic loading test on teeth restored using the post. Both occlusal and lateral loading was evaluated." It also states, "Unrestored, caries-free endodontically-treated teeth served as the control." However, the exact number of teeth or posts tested is not provided.
- Data Provenance: Not specified, but generally, such performance testing for dental devices is conducted in a laboratory setting or on extracted human or animal teeth. The document does not specify country of origin or whether it was retrospective or prospective in the context of human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical root canal post, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical performance of the device under mechanical stress.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML or diagnostic device requiring adjudication of interpretations. The performance is measured mechanistically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a physical dental device, not a diagnostic or AI system evaluated for reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical dental device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the physical performance under cyclic loading, compared to a control group of "Unrestored, caries-free endodontically-treated teeth."
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML system that requires a training set.
{0}------------------------------------------------
Foremost Dental, LLC 510(k) Premarket Notification (Traditional)
Image /page/0/Picture/1 description: The image shows a document with the number K060075 written at the top. Below the number, the text "P. 1 of 1" is visible, indicating that it is page 1 of a 1-page document. The text is in a simple, sans-serif font and appears to be a scanned or printed document. The document is likely related to some kind of official record or filing system.
January 3, 2006
Fiber-Metal Post
MAR 30 2006
| Trade Name: | Foremost Fiber-Metal Post |
|---|---|
| 510(k) Sponsor: | Foremost Dental, LLC242 South Dean StreetEnglewood, NJ 07631FDA Registration # 2244812 |
| Contact: | George Wolfe, Product Development Manager |
| Device Generic Name: | Root canal post |
| Device Classification: | Class I |
| Classification Number: | 21 CFR 872.3810 |
| Product Code: | 76 ELR |
Predicate Devices:
The Foremost Fiber-Metal Post is substantially equivalent to several currently marketed root canal posts:
| Product Name | 510(k) # | 510(k) Sponsor |
|---|---|---|
| Snowpost | K012354 | Danville Materials, Inc. |
| everStick™ Post | K030820 | Stick Tech, Ltd. |
| Fibiocore | K020431 | Anthogyr |
Indications for Use:
The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.
Product Description:
The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).
Safety and Performance:
Performance testing for the Fiber-Metal Posts consisted of a cyclic loading test on teeth restored using the post. Both occlusal and lateral loading was evaluated. Unrestored, caries-free endodontically-treated teeth served as the control. The results of this test demonstrated that the Foremost Fiber-Metal Post, when used as directed in the device labeling, results in an acceptable fatique cycle strength for the finished restoration.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Fiber-Metal Post has been shown to be safe and effective for its intended use.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2006
Foremost Dental, LLC C/O Ms. Pamela Papineau Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K060075
Trade/Device Name: Fiber-Metal Post Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: January 3, 2006 Received: January 11, 2006
Dear Ms. Papineau:
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 such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2 -Ms. Papineau
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chin Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Foremost Dental, LLC 510(k) Premarket Notification (Traditional)
510(k) Number (if known): K060075
Device Name: Fiber-Metal Post
Indications for Use:
The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runge
As General Manager
Page of
§ 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.