(146 days)
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No
The description focuses on a mechanical torque system with a ratchet mechanism and disposable inserts for calibration, with no mention of AI or ML technologies.
No
The device is used for tightening and unthreading prosthetic implant components, which are technical procedures related to the mechanics of the implant, not for diagnosing, treating, or preventing a disease or condition in a patient.
No
The device is used for tightening and unthreading prosthetic implant components to specific torque levels. It measures and applies torque, but it does not diagnose a condition or disease in a patient.
No
The device description explicitly states it utilizes a ratchet mechanism and a pre-calibrated disposable insert, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for tightening and unthreading prosthetic implant components. This is a mechanical function performed directly on a medical device (implant components) within the body or during the process of placing them.
- Device Description: The device description details a mechanical system (ratchet mechanism, disposable insert) for applying torque.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, disease, or condition. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
The DENTSPLY® PRECISION TORQUE SYSTEM is a tool used in a surgical or dental procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The DENTSPLY® PRECISION TORQUE SYSTEM is used for tightening of prosthetic implant components to their recommended torque levels to deliver an accurate torque application. The SYSTEM can also be used to unthread prosthetic screws.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The DENTSPLY® PRECISION TORQUE SYSTEM utilizes a ratchet mechanism and a pre-calibrated disposable insert. Each time the wrench is used, a new breakaway insert provides for a 100% of re-calibration. Two different insert sizes are provided.
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)
The DENTSPLY PRECISION TORQUE SYSTEM was evaluated for accuracy and reliability by examining the Torque Application and the Torque Calibration. The mean amount of torque that the new DENTSPLY® PRECISION TORQUE SYSTEM delivered for thirty samples (5 inserts) was 99.8% of the claimed 30 Ncm value, and well within the functional acceptance level that allowed for a maximum variance of ± 15%. For the competitors' products evaluated, the mean variance for the claimed application value ranged from 14,9% up to 31.48 when the tool was repeatedly used. Unique to the new DENTSPLY the DENTSPLY® PRECISION TORQUE SYSTEM maintained its precision design. calibration over time.
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
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P O Box 877 York, PA 17405-0872 171 845-751 Fax (717) 854-2343 P. J. Lehn Telefax
P. Jeffery Lehn CONTACT :
DATE PREPARED:
October 8, 1996
DENTSPLY® PRECISION TORQUE SYSTEM TRADE NAME:
21 CFR, 872.3640 CLASSIFICATION NAME: Accessory to Endosseous Implants
PREDICATE DEVICE: Calcitek Torque Wrench System K931440
DEVICE DESCRIPTION: The DENTSPLY® PRECISION TORQUE SYSTEM utilizes a ratchet mechanism and a pre-calibrated disposable insert. Each time the wrench is used, a new breakaway insert provides for a 100% of re-calibration. Two different insert sizes are provided.
INTENDED USE: The DENTSPLY® PRECISION TORQUE SYSTEM is used for tightening of prosthetic implant components to their recommended torque levels to deliver an accurate torque application. The SYSTEM can also be used to unthread prosthetic screws.
The DENTSPLY PRECISION TORQUE SYSTEM was TECHNOLOGICAL CHARACTERISTICS: evaluated for accuracy and reliability by examining the Torque Application and the Torque Calibration. The mean amount of torque that the new DENTSPLY® PRECISION TORQUE SYSTEM delivered for thirty samples (5 inserts) was 99.8% of the claimed 30 Ncm value, and well within the functional acceptance level that allowed for a maximum variance of ± 15%. For the competitors' products evaluated, the mean variance for the claimed application value ranged from 14,9% up to 31.48 when the tool was repeatedly used. Unique to the new DENTSPLY the DENTSPLY® PRECISION TORQUE SYSTEM maintained its precision design. calibration over time.
We believe that the performance data and the conceptual similarities to legally marketed competitive products demonstrate the safety and effectiveness of the DENTSPLY® PRECISION TORQUE SYSTEM for its intended uses.