(71 days)
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Not Found
No
The summary describes a mechanical abutment system for dentures and makes no mention of AI or ML.
Yes
The device is described as a restorative prosthesis intended to provide a direct attachment for tissue-supported overdentures, which is a therapeutic function.
No
The device is described as a restorative prosthesis for attaching overdentures to implants, and its intended use and description focus on this mechanical function, not on diagnosing medical conditions.
No
The device description clearly states it is a "restorative prosthesis" and describes physical components ("one-piece or a two-piece"). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "restorative prosthesis" intended to provide a "direct attachment for tissue-supported overdentures retained by two or more implants." This describes a device used in vivo (within the body) for a structural and restorative purpose.
- Device Description: The description reinforces this by calling it a "restorative prosthesis."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body to support a dental prosthesis.
N/A
Intended Use / Indications for Use
The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
Product codes
DZE
Device Description
The O-ring Abutment System is either a one-piece or a two-piece restorative prosthesis that provides a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The O-Ring Abutment System has been evaluated in laboratory conditions and by consulting implantologists and oral and maxillofacial surgeons and has been found to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence, as noted in the intended use statement.
These evaluations indicate that the O-Ring Abutment System should be safe and effective when used as intended.
Key Metrics
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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
BioHorizons Implant Systems, Inc. 510(k) Notification 01/21/99
510(k) Summary of Safety and Effectiveness
Proprietary Name
O-Ring Abutment
Common Name
Overdenture Abutment
Classification Name
Accessory to Endosseous Implants and Associated Components and Instrumentation
Classification
Class III
Official Contact
Winston Greer, VP of Operations BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 (205) 967-7880 Fax (205) 870-0304
Device Description
The O-ring Abutment System is either a one-piece or a two-piece restorative prosthesis that provides a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
Product Evaluation
The O-Ring Abutment System has been evaluated in laboratory conditions and by consulting implantologists and oral and maxillofacial surgeons and has been found to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence, as noted in the intended use statement.
These evaluations indicate that the O-Ring Abutment System should be safe and effective when used as intended.
Indications for Use
The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
Substantial Equivalence Information
The BioHorizons O-Ring Abutment System is substantially equivalent in all features that could affect the safety and effectiveness to the Lifecore Biomedical, SteriOss, and Implant Innovations, O-Ring Abutment Systems.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes on its wing, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 9 1999
Ms. Diana M. Easton BioHorizons Implants Systems, Incorporated One Perimeter Park South Suite 230 South 35243 Birmingham, Alabama
Re : K990277 Trade Name: O-Ring Abutment Regulatory Class: III Product Code: DZE January 21, 1999 Dated: January 28, 1999 Received:
Dear Ms. Easton:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 — Ms. Easton
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 (21 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
Directo Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioHorizons Implant Systems, Inc. 510(k) Notification 01/21/99
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_BioHorizons O-Ring Abutment System
Indications for Use:
The BioHorizons O-Ring Abutment System is intended to provide a direct attachment for tissue-supported overdentures retained by two or more implants with up to a 10-degree divergence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runny
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 996 510(k) Number
Prescription Use
(per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
OR