(77 days)
No
The document describes standard dental implant accessories and instruments, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is described as "accessories" and "components" used with an implant system, rather than a device intended to treat or cure a disease or condition itself.
No
The device description states it includes components like abutments, healing abutments, and instruments used with implant systems, which are used for treatment and not for diagnosing a condition.
No
The device description explicitly lists physical components such as Abutments, Healing Abutments, Hand Instruments, Impression Copings, and Machine Instruments, indicating it is a hardware device with accessories.
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 used as accessories in conjunction with an endosseous implant system. This involves surgical procedures and the placement of implants within the body.
- Device Description: The description lists components like abutments, healing abutments, and instruments used in dental implant procedures. These are physical components used in a clinical setting, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed 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® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.
Product codes
Not Found
Device Description
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform They include Abutments, Healing Abutments, Hand Fixtures. Instruments, Impression Copings and Machine Instruments.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
K925770, K925768, K925774, K925779, K925771, K925775
Reference Device(s)
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
K96240B
SEP - 6 1996
Pre-market Notification June 19, 1996 Page -3-이 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바
VII. 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 Their telephone number is: (708) 654-9100 and the contact 60559. person will be the Director, Regulatory Affairs. This summary was prepared on June 19, 1996.
B. Name of the Device
This consists of numerous components to be used in conjunction with the BRANEMARK SYSTEM® - Wide Platform Fixtures, including Hand Instruments, Healing Abutments, . Impression Copings, Machine Instruments and accessories specific to the MirusCone and CeraOne system.
C. The Predicate Product
The predicate products used in this Premarket Notification are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 system.
D. Description of the Device
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform They include Abutments, Healing Abutments, Hand Fixtures. Instruments, Impression Copings and Machine Instruments.
E. Intended Use of the Device
The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.
F. Comparison of Technological Characteristics
The technological characteristics between the components of Wide Platform Accessories and the corresponding predicate product, a comparable component in the BRANEMARK SYSTEM®, are identical.