(140 days)
Not Found
No
The summary describes a physical dental device made of composite materials and stainless steel, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The Bio-Post stabilizes and supports a restoration, which is a structural rather than a therapeutic function.
No
The device, Bio-Post, is described as a dental root canal post intended to stabilize and support a restoration, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is fabricated from physical materials (glass fibers, vinyl ester matrix, stainless steel wire) and is intended to be cemented into a tooth, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be cemented into a tooth's root canal to stabilize and support a restoration. This is a therapeutic or restorative function, not a diagnostic one.
- Device Description: The description details the materials and structure of a physical implant for dental use. It doesn't describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVDs are used to perform tests on samples like blood, urine, or tissue to help diagnose diseases or conditions. The Bio-Post is a physical device implanted in the body for structural support.
N/A
Intended Use / Indications for Use
The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.
Product codes
ELR
Device Description
The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth / root canal
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
Comparative Information: Tensile strength and modulus of elasticity of the Bio-Post was compared to aluminum, titanium, and stainless steel posts. The results show the Bio-Post has a lower modulus, and higher tensile properties than alloy and steel posts.
Biocompatibility testing of the materials showed them to be biocompatible.
Key Metrics
Not Found
Predicate Device(s)
These devices are substantially equivalent to austenitic alloy root canal posts legally marketed by Essential Dental Systems.
Reference Device(s)
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
Tru-Flex Post Systems, Inc. Bio-Post 510(k) Notification Attachment 1
Bio-Post Dental Post System Summary of Safety and Efficacy
Submitter Information:
1998
MAY
Tru-Flex Post Systems, Inc. 438 Bay Ridge Parkway Brooklyn, NY 11209
510(k) Summary Prepared by:
Carolann Kotula Official Correspondent for Tru-Flex Post Systems c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared:
December 9, 1997
Root Canal Post
Root Canal Post
Name/Classification of the Device:
Classification Name:
Common Name:
Proprietary Name:
Classification:
Bio-Post Dental Post System
872.3810
1
Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: These devices are substantially equivalent to austenitic alloy root canal posts legally marketed by Essential Dental Systems.
Comparative Information: Tensile strength and modulus of elasticity of the Bio-Post was compared to aluminum, titanium, and stainless steel posts. The results show the Bio-Post has a lower modulus, and higher tensile properties than alloy and steel posts.
Description of the Subject Device: The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.
Intended Use of the Subject Device: The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Technological Characteristics of the Subject Device: The material and material orientation of the Bio-Post is a technological characteristic more advanced than the traditional root canal posts made of austenitic alloys. This allow the Bio-Post to have a lower modulus, and higher tensile properties than alloy and steel posts.
Biocompatibility testing of the materials showed them to be biocompatible.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1998
Tru-Flex Post Systems Incorporated C/O Ms. Carolann Kotula Vice President RA/QA mdi Consultants, Incorporated 55 Northern Boulevard Great Neck, New York 11021
Re : K974649 Trade Name: Bio-Post Dental Post System Regulatory Class: I Product Code: ELR Dated: April 7, 1998 Received: April 8, 1998
Dear Ms. Kotula:
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 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 regulation may result in regulatory 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 through 542 of
3
Page 2 - Ms. Kotula
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 (2) 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" (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
Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Tru-Post Systems, Inc. Bio-Post 510(k) Notification Attachment 3
510(k) Number (if known): K974649
Device Name: Tru-Flex Post Systems Inc., Bio-Post Dental Post System
Indications for Use:
The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.
(Please Do Not Write Below this Line/Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number
OR
Prescription Use
(per 21 CFR 801.109) √
Over the Counter Use