(49 days)
The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The system consists of a small implant that is screwed into the jawbone that will be removed after completion of treatment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by flowing lines, symbolizing health and human services.
Public Health Service
APR 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent J. Morgan President BICON, Incorporated 501 Arborway Boston, Massachusetts 02130
Re: K050408
Trade/Device Name: Bicon Orthodontic Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: February 16, 2005 Received: February 17, 2005
Dear Mr. Morgan:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 970(t) procession is substantially equivalent (for the referenced above and have determined the do needing marketed predicate devices marketed in indications for use stated in the chelosaro, to regionent date of the Medical Device interstate collinerce prior to triay 20, 1978, career with the provisions of Amendments, of to devices that have been freating that do not require approval of a premarket the Federal Food, Drug, and Cosmetic Press, market the device, subject to the general approval application (1 Mr.). Tour my, "The general controls provisions of the Act include controls provisions of the rec. "The genting of devices, good manufacturing practice, requirements for anilad reasonst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting.
(PMA), it may be subject to such additional controls. Title 21 Rerta 800 to 8 (PMA), it may be subject to such additional controls. "Eitle 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, 2017 the Federal your device can be found in the Code of Peachartegiments concerning your device in the Federal Register.
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Page 2 - Mr. Morgan
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issualice of a sostance with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemination that your and ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administration to: registration of the Act or any Federal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's require and manufacturing progrice You must comply with an the Act 3 requirements and 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFK Part 807), laocimig (21 OFF Crich are 3,5 ]
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set form in the quality Systems (QD) regarities (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) This letter will allow you to begin marketing your also ware of your device to a
premarket notification. The FDA finding of substantial equivalerse ond thus, net premarket notification. The PDA midme of substantial of the rour 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), If you desire specific advice for your de records & Also, please note the regulation please contact the Office of Comphance at (210) = 10 ification" (21CFR Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR) the entitled, "Misoranding by reference to premation on your responsibilities under the Act from the may obtain offier general information on Joan Land Consumer Assistance at its toll-free DIVIsion of Sinan Manazarians (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syfitte Michaut ms
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
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Indications for Use
510(k) Number (if known): K050408
Device Name:
Bicon Orthodontic Implant System
Indications for Use:
The Bicon Orthodontic Implant System is intended for those cases where a clinician desires The Bicon Orthodontic Implant System is nitendomic appliances may be attached to
to provide a fixed point of anchorage to which orther is screwed into the to provide a fixed point of allcholage to wills one of that is screwed into the of modontically move tess.
jawbone that will be removed after completion of treatment.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sweeny Russo
ausion Sion-Off) Wision of Anesthesiology, General Hospital, Infection Control, Dental Devices
Number: Ko Saudox
Page 1 of 1
§ 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.