DENTSPLY PRECISION TORQUE SYSTEM
Device Facts
| Record ID | K964046 |
|---|---|
| Device Name | DENTSPLY PRECISION TORQUE SYSTEM |
| Applicant | Dentsply Intl. |
| Product Code | DZE · Dental |
| Decision Date | Mar 4, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
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.
Device Story
Manual torque wrench system for dental implant procedures; utilizes ratchet mechanism with pre-calibrated disposable breakaway inserts. Each insert provides single-use calibration; two insert sizes available. Operated by dental clinicians in clinical settings. Device applies specific torque to prosthetic components; ensures accurate tightening; facilitates screw removal. Benefits include consistent torque application and maintained precision over time compared to reusable tools prone to calibration drift.
Clinical Evidence
Bench testing only. Evaluated torque application accuracy and calibration reliability. Tested 30 samples (5 inserts); mean torque delivery was 99.8% of 30 Ncm target. Performance compared against competitor products, which exhibited mean variances between 14.9% and 31.4%.
Technological Characteristics
Manual ratchet-based torque wrench; disposable breakaway inserts for calibration. Mechanical operation; no energy source. Dimensions/materials not specified. Standalone device.
Indications for Use
Indicated for tightening prosthetic implant components to recommended torque levels and unthreading prosthetic screws in patients requiring dental implant procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Calcitek Torque Wrench System (K931440)
Related Devices
- K991283 — DYNA TORQ TORQUE WRENCH, TORQUE WRENCH · Micro Motors, Inc. · Aug 18, 1999
- K110278 — CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 · Nakanishi, Inc. · Feb 15, 2012
- K963951 — AS 123 PROSTHETIC INSTRUMENTATION SYSTEM · BioHorizons Implant Systems, Inc. · Dec 31, 1996
- K161500 — MEG-TORQ · Micro-Nx Co., Ltd. · Feb 22, 2017
- K964739 — STERI-OSS TIODIZED SCREW · Steri-Oss, Inc. · Mar 31, 1997
