INTRA-LOCK OP DENTAL IMPLANT
Device Facts
| Record ID | K130140 |
|---|---|
| Device Name | INTRA-LOCK OP DENTAL IMPLANT |
| Applicant | Intra-Lock International |
| Product Code | DZE · Dental |
| Decision Date | Aug 1, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function. 3.75mm, 4.0mm and 4.75mm Intra-Lock® OP Dental Implants: Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
Device Story
Intra-Lock® OP Dental Implants are one-piece, threaded endosseous implants (diameters 3.0mm–4.75mm) with integrated straight abutments. Used by dental clinicians in clinical settings to restore edentulous spaces. Principle of operation: instrumentation engages the machined abutment for pick-up, delivery, and seating; impression caps snap over the abutment for model creation. Output is a stable foundation for fixed or removable dental prostheses. Benefits include restoration of normal tooth function and aesthetics for patients. No software or electronic components involved.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, including risk analysis, shelf life validation, sterilization validation, surface analysis, and static/dynamic fatigue testing.
Technological Characteristics
Materials: TI6AL4V and CP Titanium. Design: One-piece threaded endosseous implant with integrated straight abutment. Surface: Blasted. Thread patterns: Wide pitch (with/without cutting flutes) and Blossom designs with horizontal micro-threads. Sterilization: Gamma irradiation. Shelf life: 5 years.
Indications for Use
Indicated for partially or fully edentulous patients requiring dental restoration, including denture stabilization, single tooth replacement, or full arch reconstruction in the maxilla or mandible. 3.0mm implants specifically indicated for lateral/central incisors and denture stabilization. Suitable for immediate or delayed loading contingent on primary stability.
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
- Zimmer® One-Piece Implant (K052997)
- Zimmer® One-Piece Implant (K062281)
- MILO® Implant System (K050970)
- Intra-Lock® Implant System with Blossom™ (K103194)
