(77 days)
Not Found
None
No
The summary describes a mechanical abutment system and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as an abutment system for dental crowns and bridgework, which is used to support and restore the function of teeth, aligning with the definition of a therapeutic device.
No
The device, a Bicon Two Part Abutment, is described as being used for the "support of a terminal or intermediate crown for fixed bridgework or for a single tooth crown." This indicates a prosthetic or restorative function, not a diagnostic one. It does not identify or characterize a disease, condition, or state, which are hallmarks of a diagnostic device.
No
The device description explicitly states "Two Part Abutment System," which is a physical implant component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in the body (mandible or maxilla) to support crowns or bridgework. This is a surgical or prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The description "Two Part Abutment System" further reinforces its nature as a physical component used in dental procedures.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a physical implant used in a surgical/dental procedure.
N/A
Intended Use / Indications for Use
The Bicon Two Part Abutment is designed for use in the mandible or maxilla for The Droof a terminal or intermediate crown for fixed bridgework or for a single tooth crown.
Product codes
DZE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vincent Morgan, D.M.D. President Bicon, Incorporated 1153 Centre Street 02130 Boston, Massachusetts
UG 1 8 1997
Re : K972029 Bicon Dental Implants Two Part Abutment Trade Name: System Requlatory Class: III Product Code: DZE Dated: May 20, 1997 June 2, 1997 Received:
Dear Dr. Morgan:
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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation 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
1
Page 2 - Dr. Morgan
through 542 of the Act for devices under the Electronic chrough 542 or the 1100 in 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 gescribed in your 510\n premaince of your device to a legally marketed predicate device results in a classification for your marketed predicate actres 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 ritro diagnostic devices), please contact the Office of Vitio draghobere actrios, / 18. Additionally, for questions on compriation and advertising of your device, please contact the Dromocion and adversions of (301) 594-4639. Also, please note the Orice Of Compriand, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general prematice noctrout responsibilities under the Act may be Information on your responsible Manufacturers Assistance oblained from the Divibion (800) 638-2041 or (301) 443-6597 or at at its coll free namber (o:s)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
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
PM. JACOBTHAI
Page
K972029 510(k) Number (if known):
Two Part Abutment System Device Name:
Indications For Use:
The Bicon Two Part Abutment is designed for use in the mandible or maxilla for The Droof a terminal or intermediate crown for fixed bridgework or for a single tooth crown.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number R972029
Prescription Use in (Per 21 Ci-R 801.109)
ਾਕ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
SK-77