INTRA-LOCK OP DENTAL IMPLANT

K130140 · Intra-Lock International · DZE · Aug 1, 2013 · Dental

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

Intended 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)

Submission Summary (Full Text)

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### 510(k) SUMMARY

# AUG

| Submitter's Name: | Intra-Lock® International<br>6560 West Rogers Circle<br>Boca Raton, FL 33487 | | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] | | | |
| Facsimile: | [phone] | | | |
| Contact Person: | Diana Taylor | | | |
| Date Prepared: | July 30, 2013 | | | |
| Name of Device: | Intra-Lock® OP Dental Implants | | | |
| Common Name: | Dental Implant | | | |
| Classification Name: | Implant, Endosseous, Root-Form | | | |
| Classification: | Class II | | | |
| Regulation Number: | 872.3640 | | | |
| Product Code: | DZE | | | |
| Predicate Devices: | K052997 & K062281 Zimmer® One-Piece Implant<br>K050970, MILO® Implant System,<br>K103194, Intra-Lock® Implant System with Blossom™ | | | |
| Description | The Intra-Lock® OP Dental Implants are threaded dental<br>implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with<br>an integrated straight abutment (implant and abutment arc one<br>piece). | | | |
| Intended Use: | The 3.0mm Intra-Lock® OP Dental Implants are indicated for<br>long-term maxillary and mandibular tissue-supported denture<br>stabilization. They are also indicated for the rehabilitation of<br>single or maxillary lateral incisors and mandibular lateral and<br>central incisors. Multiple implants may be restored after a<br>period of delayed loading or placed in immediate function<br>when good primary stability is achieved with appropriate<br>occlusal loading in order to restore normal teeth function. | | | |
| | 3.75mm, 4.0mm and 4.75mm Intra-Lock® OP Dental Implants:<br>Intra-Lock® Implants have been designed to restore partially<br>or fully edentulous patients. The implants have been designed<br>to be used in either the mandible or the maxilla and to support<br>removable or fixed prostheses, from single tooth replacement<br>to full arch reconstruction. Intra-Lock® Implants are intended<br>for immediate function on single tooth and/or multiple tooth<br>applications when good primary stability is achieved, with<br>appropriate occlusal loading, in order to restore normal tecth<br>functions. | | | |
| Performance Testing: | The following was reviewed to support performance of the<br>Intra-Lock® OP Dental Implants for their intended use: risk<br>analysis, shelf life and sterilization validation, surface analysis<br>and static / dynamic fatigue. | | | |
| | Proposed OP Implants<br>3.0mm 3.75mm, 4.0mm & 4.75mm | Zimmer & One-Piece,<br>K052997 - 3.0mm & 3.7mm<br>K062201 - 4.7mm | Intra-Lock MILO® 3.0mm<br>Implants, K050970 | Intra-Lock® Dental Implant<br>System with Blossom™,<br>K103194 |
| Material | TI6AL4V, CP Titanium | Titanium Alloy | TI6AL4V | TI6AL4V, CP Titanium |
| Surface | Blasted | Zimmer MTX Surface | Blasted | Blasted |
| Thread<br>Patterns | - 3.0mm, wide pitch, no cutting flutes<br>- 3.75mm wide pitch w/ cutting flutes<br>- 4.0mm & 4.75mm Blossom<br>All designs feature horizontal micro threads | cutting flute on the apical end no horizontal<br>micro threads | Wide pitch, no cutting flutes,<br>horizontal micro threads | Blossom - at least one cutting<br>surface on each thread and<br>horizontal micro threads. |
| Design sizes | 3.0mm.3.75mm 4.0mm& 4.75mm dia;<br>10mm - 15mm lengths | 3.0mm dia, 10-13mm lengths<br>3.7mm & 4.7mm dia ; 10 - 16mm lengths | 3.0mm, O-Ball implant<br>10mm - 15mm lengths | 3.5mm, 4.0mm (& 6.0mm) dia;<br>8mm - 15mm lengths |
| Abutment | Straight abutment machined on implant | Straight abutment machined on implant | Abutments cemented | Screw retained abutments via<br>internal connection |
| Principals of<br>Operation | Machined abutment has mating features so<br>the design specific driver fits directly over<br>the abutment for pick up, delivery<br>(placement) and final seating.<br>The OP transfer is snapped over the<br>abutment to be picked up in the impression.<br>The OP analog is inserted into the transfer<br>prior to creating the working model. | Instrumentation engage the implant<br>externally to pick up deliver and seat the<br>implant.<br>The impression cap snaps over the abutment<br>and picked up in the impression.<br>The analog replicates the Zimmer One-Piece<br>Implant in the stone model. | Instrumentation fits over the<br>O-Ball for pick up, delivery<br>and final seating.<br>MILO impression coping<br>snaps over the O-Ball to be<br>picked up in the impression.<br>The MILO analog is inserted<br>into the transfer prior to<br>creating working model | Instrumentation pick up the<br>Blossom implant via hex<br>configuration which mates with<br>the internal connection of the<br>implant.<br>A screw retains the impression<br>coping. Analogs are placed in<br>the transfer and secured with<br>screw. |
| Intended use | The 3.0mm Intra-Lock® OP Dental Implants<br>are indicated for long-term maxillary and<br>mandibular tissue-supported denture<br>stabilization. They are also indicated for the<br>rehabilitation of single or maxillary lateral<br>incisors and mandibular lateral and central<br>incisors. Multiple implants may be restored<br>after a period of delayed loading or placed in<br>immediate function when good primary<br>stability is achieved with appropriate<br>occlusal loading in order to restore normal<br>teeth function.<br>3.75mm 4.0mm and 4.75mm;<br>Intra-Lock® Implants have been designed to<br>restore partially or fully edentulous patients.<br>The implants have been designed to be used<br>in either the mandible or the maxilla and to<br>support removable or fixed prostheses, from<br>single tooth replacement to full arch<br>reconstruction. Intra-Lock® Implants are<br>intended for immediate function on single<br>tooth and/or multiple tooth applications<br>when good primary stability is achieved, with<br>appropriate occlusal loading in order to<br>restore normal teeth functions. | Zimmer One-Piece 3.0mm implants are<br>indicated for the support and retention of<br>fixed single tooth and fixed partial denture<br>restorations in the mandibular central and<br>lateral incisor and maxillary lateral incisor<br>regions of partially edentulous jaws. The<br>Zimmer one piece 3.0mm implant must be<br>splinted if two or more are used adjacent to<br>each other. The Zimmer One Piece 3.0mm<br>implant may be immediately restored with a<br>temporary prosthesis that is not in functional<br>occlusion.<br>Zimmer One-Piece 3.7mm & 4.7mm implants<br>are indicated for the support and retention of<br>fixed single tooth and fixed partial denture<br>restoration in the premolar, cuspid and<br>incisor regions of partially edentulous jaws.<br>Zimmer one-piece implants may be loaded<br>immediately in the anterior mandibular arch<br>if four are splinted together with a bar. The<br>Zimmer one-piece implant may be<br>immediately restored with a temporary<br>prosthesis that is not in functional occlusion. | MILO® Dental Implants are<br>indicated for long-term<br>maxillary and mandibular<br>tissue supported<br>denture stabilization. They<br>are also indicated for the<br>rehabilitation of single or<br>maxillary lateral incisors and<br>mandibular lateral and<br>central incisors. Multiple<br>implants may be restored<br>after a period of time or<br>placed in immediate function. | Intra-Lock® Implants have<br>been designed to restore<br>partially or fully edentulous<br>patients. The implants have<br>been designed to be used in<br>either the mandible or the<br>maxilla and to support<br>removable or fixed prostheses,<br>from single tooth replacement<br>to full arch reconstruction.<br>Intra-Lock® Implants are<br>intended for immediate<br>function on single tooth and/or<br>multiple tooth applications<br>when good primary stability is<br>achieved, with appropriate<br>occlusal loading, in order to<br>restore normal teeth functions. |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Shelf Life | 5 years…