(90 days)
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No
The device description and intended use clearly describe a physical kit of trial models used for manual selection, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is a selection kit used by practitioners to choose the proper abutment, rather than directly treating a condition or disease. It is a diagnostic/selection tool for pre-treatment planning.
No
Explanation: The device is an 'Abutment Selection Kit' used by practitioners to physically select the proper abutment from trial models. It does not perform a diagnostic function by identifying a disease, condition, or risk. Its purpose is to aid in the physical selection of a medical device component.
No
The device description explicitly states it consists of "trial models of various abutments," which are physical components, 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 select the proper abutment for dental implants. This is a mechanical selection process, not a diagnostic test performed on biological samples.
- Device Description: The device consists of trial models used for physical selection in the mouth or on a model. It does not involve analyzing biological specimens (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, performing chemical reactions, or providing diagnostic information based on biological markers.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient's mouth and/or on a plaster model. The abutment selection system is used in a patient's mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.
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
practitioners
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.
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
Pre-Market Notification February 7, 1996 Page -2-
MAY 1 4 1996
VI. 510 (k) Summary of Safety and Effectiveness
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is: (708) 654-9100 and the contact person will be the Director, Requlatory Affairs. This summary was prepared on February 7, 1996.
B. Name of the Device
The device is generally known as trial model abutments used fitting purposes, and will have the trade name "BRANEMARK for SYSTEM® Abutment Selection Kit."
C. The Predicate Product
The predicate products used in this Premarket Notification is the abutment selection kit, K944963.
D. Description of the Device
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient's mouth and/or on a plaster model. The abutment selection system is used in a patient's mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.
E. Intended Use of the Device
The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.
F. Comparison of Technological Characteristics
The technological characteristics between the two Abutment Selection Kits are identical. The proposed colorant method is used to provide a bright color distinction between the "trial" abutments and the abutments intended for long-term use.