PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT

K130462 · Paltop Advanced Dental Solutions, Ltd. · DZE · Aug 27, 2013 · Dental

Device Facts

• Record ID: K130462
• Device Name: PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
• Applicant: Paltop Advanced Dental Solutions, Ltd.
• Product Code: DZE · Dental
• Decision Date: Aug 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

Paltop Narrow Implant is a single-use, endosseous, screw-type dental implant with an internal hexagonal connection; functions as a substitute for a natural tooth. Fabricated from titanium alloy (Ti-6Al-4V ELI); surface treated via sandblasting and acid etching. Used by dental professionals in clinical settings to support prosthetic devices (artificial teeth) in patients with narrow alveolar ridges or limited horizontal space between adjacent teeth/roots. Eliminates need for bone augmentation or orthodontic movement. Implant is placed surgically; provides support for prosthetic superstructures. Benefits include restoration of chewing function in anatomically constrained sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fatigue testing, corrosion resistance, surface analysis, biocompatibility evaluation, sterilization, and shelf-life validation.

Technological Characteristics

Material: Titanium-6 Aluminum 4 Vanadium ELI alloy (ASTM F136-98). Design: Endosseous screw-type, 3.25mm diameter, lengths 10-16mm. Connection: Internal hexagonal. Surface: Sandblasted and acid-etched. Sterilization: Sterile, single-use.

Indications for Use

Indicated for partially edentulous patients requiring dental implants in mandibular central/lateral incisor or maxillary lateral incisor regions where horizontal space is limited. Suitable for immediate loading if primary stability and appropriate occlusal loading are achieved.

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

• Paltop Dental Implant System (K112795)
• UNO Narrow Implant (K092555)
• Osseospeed Narrow (K080396)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a bold, modern font. Below the company name and logo is the tagline "With you to the TOP" in a cursive font.

510(k) SUMMARY

510(k) Number K | 3046 2

Applicants Name: Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T [phone] F [phone]

Contact Person: Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T [phone] F [phone] Email: [e-mail]

AUG 27 2013

- February 18th, 2013 Date Prepared:
Trade Name: Paltop Narrow Implant

Classification Name: Implant, Endosseous, Root-form

Common usual name: Dental Implant

Medical Specialty: Dental

Product Code: DZE, NHA

- Device Class: Class II
- Regulation Number: 872.3640
- Review Panel: Dental Device Panel

Predicate Devices:

Paltop Narrow Implant is relying on the combination of the following predicate devices:

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Image /page/1/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left, followed by the word "PALTOP" in a bold, sans-serif font. A small circle with a degree symbol is located to the right of the "P". The text "With you to the TOP" is written in a cursive font below the logo.

- Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared . under K112795; product code DZE, NHA (Implant, Endosseous, Root-Form).
- UNO Narrow Implant (MIS Implant Technologies Ltd.) cleared under K092555; . product code DZE, NHA (Implant, Endosseous, Root-Form).
- Osseospeed " Narrow (ASTRA Tech AB) cleared under K080396; product code . DZE,NHA (Implant, Endosseous, Root-Form)

# Intended Use / Indication for Use:

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

#### Device Description:

Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching.

The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is

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Image /page/2/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a modern, sans-serif font. Below the company name is the tagline "With you to the TOP" in a cursive font.

limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided.

The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

# Substantial Equivalence:

The proposed Paltop Narrow Implants have similar indications for use, technological characteristics, mode of operation and performance specification as the predicates MIS Implants and Astra-Tech Implants. The proposed devices have the same intended use as the predicates and are placed using the same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.

| | PALTOP Narrow | PALTOP Dental | MIS UNO Narrow | Astra Tech |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | lmplants | Implant System | lmplant | OsseoSpeed Narrow |
| K# | | Cleared under | Cleared under | Cleared under |
| | | K#112795 | KHO92555 | K#080396 |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Manufacturer | Paltop Advanced | Paltop Advanced | MIS Implant | Astra Tech AB |
| | Dental Solutions Ltd. | Dental Solutions Ltd. | Technologies Ltd. | |
| Intended Use/ | The Narrow Implant is | The Paltop Dental | The UNO Narrow | The OsseoSpeed |
| Indications for | indicated for use in | lmplant System is | implant is indicated | Narrow is intended to |
| Use | surgical and | indicated for use in | for use in surgical and | be used to replace |
| | restorative | surgical and | restorative | missing masticatory |
| | applications for | restorative | applications for | functional units |
| | placement in the | applications for | placement in the | (teeth) in single or |
| | mandibular central, | placement in the | mandibular central, | multiple unit |
| | lateral incisor and | bone of the upper or | lateral incisor and | applications within |
| | maxillary lateral | lower jaw to provide | maxillary lateral | the mandible or |
| | incisor regions of | support for prosthetic | incisor regions of | maxilla. The device |
| | partially edentulous | devices, such as | partially edentulous | may be equally well in |
| | jaws where the | artificial teeth, in | jaws where the | single-stage or two- |
| | horizontal space is | order to restore the | horizontal space is | stage surgical |
| | limited by the | patient's chewing | limited by the | procedure. It is |
| | adjacent teeth and | function. The Paltop | adjacent teeth and | indicated for |
| | PALTOP Narrow | PALTOP Dental | MIS UNO Narrow | Astra Tech |
| | Implants | Implant System | Implant | OsseoSpeed Narrow |
| | roots, to provide | Dental Implant<br>System is indicated<br>also for immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | roots,<br>jaw to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function. Mandibular<br>central and lateral<br>incisors must be<br>splinted if using two<br>or more φ3.0mm<br>implnats adjacent to<br>one another. . The<br>UNO Narrow Implant<br>is indicated for<br>immediate<br>implantation in the<br>extraction sites or<br>implantation in<br>partially healed or<br>completely healed<br>alveolar ridge<br>situations.<br>When a one stage<br>surgical procedure is<br>applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achived and the<br>occlusal load is<br>appropriate. | immediate<br>implantation in<br>extraction sites or<br>implantation in<br>partially healed<br>alveolar ridge<br>situations. When a<br>one-stage surgical<br>approach is applied,<br>the implant may be<br>immediattely loaded<br>when good primary<br>stability is achived<br>and functional load is<br>appropriate. The<br>OsseoSpeed Narrow<br>product line shall be<br>used only to replace<br>maxillary lateral<br>incisors and<br>mandibular lateral<br>and central incisors.<br>The fluoride-modified<br>surface, though<br>having a fluoride ion<br>level far below the<br>needed for caries<br>prevention in theeth,<br>provides a favorable<br>substrate for bone<br>attachment and<br>osseointegration.<br>OsseoSpeed Narrow<br>is especially indicated<br>for use in soft bone<br>applications where<br>implants with other<br>implant surface<br>treatment may be<br>less effective.Because<br>initial stability may be<br>difficult to obtain in<br>Type IV bone,<br>immediate loading of<br>sungle tooth<br>restorations may not<br>be appropriate in<br>such situations. |
| Components | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures;<br>surgical instruments. | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; |
| Clinical Data | Not applicable | Not applicable | Not applicable | Not applicable |
| | PALTOP Narrow<br>Implants | PALTOP Dental<br>Implant System | MIS UNO Narrow<br>Implant | Astra Tech<br>OsseoSpeed Narrow |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes |
| Re-Use | No | No | No | No |
| Material<br>Composition | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
| Surface<br>treatment | Sand Blasting and<br>Acid Etching | Sand Blasting and<br>Acid Etching | Sand Blasting and<br>Acid Etching | Fluride-modified<br>surface |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Length | 10mm, 11.5mm,<br>13mm, 16mm | 8mm, 10mm,<br>11.5mm, 13mm,<br>16mm | 10mm, 11.5mm,<br>13mm, 16mm | 11mm, 13mm, 15mm |
| Diameters | 3.25mm | 3.75mm, 4.2mm,<br>5.0mm | 3.0mm | 3.0mm |
| Abutments | Straight and up to 20° | Straight and up to 25° | Straight and up to 20° | Straight and up to 20° |
| Material<br>Composition of<br>Abutments | Titanium al…