(90 days)
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No
The device description details a purely mechanical, hand-operated instrument for dental procedures, with no mention of software, data processing, or any terms related to AI/ML.
No.
The device description indicates it is a hand-operated instrument for installing and removing dental implant components, not for treating a condition or disease.
No
The device description indicates that the AS 123 Prosthetic Instrumentation System is used for installing and removing components in dental implant procedures, which are interventional actions, not diagnostic ones.
No
The device description explicitly states it is a "hand-operated instrument" and lists components made from "surgical grade stainless steel," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device's purpose is to facilitate the installation and removal of components in dental implant procedures. This is a surgical/mechanical function, not a diagnostic one performed on in vitro samples.
- Device Description: The description focuses on the physical nature of the device (hand-operated instrument, surgical grade stainless steel) and its mechanical function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the AS 123 Prosthetic Instrumentation System falls under the category of a surgical instrument used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures. All components are manufactured from surgical grade stainless steel.
The primary advantages of the AS 123 over other prosthetic instruments are as follows:
advantage of vision and easy access to difficult-to-reach posterior regions .
1 C
- tactile feedback of screw placement and removal ●
- control of torque associated with the operation ●
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 September 27, 1996
Dec. 31, 1996
0
NA
510(k) Summary of Safety and Effectiveness
Proprietary Name
AS 123 Prosthetic Instrument System
Common Name
Screw installation and removal instrument
Classification Name -
Prosthetic accessory
Classification
Class III
Official Contact
R. Steven Boggan, M.S., M.B.A. President BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, AL 35209 (205) 871-1345 FAX (205) 870-0304
Device Description
The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures. All components are manufactured from surgical grade stainless steel.
The primary advantages of the AS 123 over other prosthetic instruments are as follows:
advantage of vision and easy access to difficult-to-reach posterior regions .
1 C
- tactile feedback of screw placement and removal ●
- control of torque associated with the operation ●
1
BioHorizons Implant Systems, Inc. 510(k) Notification September 27, 1996
The thumbwheel operation provides excellent tactile feedback in placement of prosthetic components. Driver bits are easily interchangeable with the AS 123 instrument. A t-handle attachment provides the necessary torque for installation of abutment screws.
Substantial Equivalence Information
The AS 123 Prosthetic Instrumentation System is substantially equivalent in all features which could affect safety or effectiveness to the Steri-Oss® "Prosthetic Instrumentation" and Implant Innovations, Inc. "Drivers and Placement Instruments"