INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
Device Facts
| Record ID | K130572 |
|---|---|
| Device Name | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM |
| Applicant | Implant Direct Sybron Manufacturing, LLC |
| Product Code | DZE · Dental |
| Decision Date | Dec 24, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Device Story
The InterActive/SwishPlus2 Implant System comprises two-piece, screw-type endosseous dental implants, abutments, and screws. Implants feature tapered bodies with specific thread configurations (double-lead/quadruple-lead for InterActive; single-lead/micro-grooves for SwishPlus2) and internal hex connections. Available in various diameters and lengths, they are constructed from titanium alloy. Used by dental professionals in clinical settings for one- or two-stage surgical placement to support prosthetic restorations. The system is prosthetically compatible with specific Nobel Biocare NobelActive abutments. The device provides a foundation for artificial teeth, restoring chewing function and esthetics. Clinical benefit is derived from the mechanical support of dental prostheses in edentulous sites.
Clinical Evidence
No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including static compression, fatigue, and torque-to-failure testing conducted in accordance with FDA guidance and ISO 14801, and sterilization validation per ISO 17665.
Technological Characteristics
Materials: Titanium 6Al-4V ELI. Surface treatments: SBM (Soluble Blasted Media) or HA (Hydroxyapatite) coating. Design: Threaded, root-form endosseous implants with internal hex connection. Sterilization: Validated per ISO 17665-1&2. Connectivity: None (mechanical device).
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations, fixed bridgework, or denture stabilization. Narrow diameter implants (3.2-3.3mm) indicated for mandibular central/lateral incisors and maxillary lateral incisors. Suitable for immediate loading if primary stability is 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
- NobelActive 3.0 (K102436)
- NobelActive Internal Connection Implants (K071370)
- Spectra-System Dental Implants 2008 (K090234)
- Spectra-System Abutments 2008 (K081101)
- SwissPlant Dental Implant System (K081396)
- Spectra-System (K061319)
- Bicon Implants with a 2.5mm Internal Connection (K092035)
- Bicon 5.0x5.0mm Dental Implant and 6.0x5.0 Dental Implant (K073368)
- Straumann ITI Dental Implant System (K030007)
Submission Summary (Full Text)
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KISOS 72
Image /page/0/Picture/1 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "simply smarter." written in a smaller font below. The logo also includes the text "Sybron Dental Specialties" in a smaller font below the tagline. The logo is enclosed in a rounded rectangle.
| DEC 24 2013 |
|---------------------------------------|
| InterActive/SwishPlus2 Implant System |
Traditional 510(K) Submission
# 510(K) Summary (21CFR 807.92(c))
1. Submitter's Information: Company Name: Implant Direct Sybron Manufacturing LLC 27030 Malibu Hills Rd., Calabasas Hills, CA USA 91301 Address: Telephone: 818-444-3300 818-444-3406 Fax: 3001617766 Registration No.: Contact: Ines Aravena December 17, 2013 Date Prepared: 2.
### Device Name and Classification: InterActive/SwishPlus2 Implant System Device Trade Name: Classification Names: Implant, Endosseous, Root-Form and Abutment, Implant, Dental, Endosseous Common Names: Endosseous Dental Implant and Endosseous Dental Implant Abutment Regulation Number: 872.3630 and 872.3640 Product Codes: DZE and NHA Requiatory Class: II
### 3. Predicate Device(s):
NobelActive 3.0 (K102436) NobelActive Internal Connection Implants (K071370) Spectra-System Dental Implants 2008 (K090234) Spectra-System Abutments 2008 (K081101) SwissPlant Dental Implant System (K081396) Spectra-System (K061319) Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon 5.0x5.0mm Dental Implant and 6.0x5.0 Dental Implant (K073368) Straumann ITI Dental Implant System (K030007)
#### 4. Device Description:
The InterActive/SwishPlus2 Implant System consists of InterActive implant, SwishPlus2 implant, abutments, healing components, and screws for use in one or two-stage placement and restorations.
The InterActive implants are two-stage implants that offer four body diameters (3.2, 3.7, 4.3 and 5.0mm) in six lengths (All 6 thru 16mm except for the 3.2 which is 8-16mm). The SwishPlus2 implant body diameters (3.3, 4.1, 4.8, and 5.7mm) in six lengths (All 6 thru 16mm except for the 3.3mm which is 8-16mm).
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Image /page/1/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "simply smarter." in smaller letters below. Underneath the company name and tagline is the text "Sybron Dental Specialties". The logo is enclosed in a rectangular border.
InterActive/SwishPlus2 Implant System
## InterActive Dental Implants
The InterActive dental implant is a tapered screw-type endosseous with an external thread configuration consisting of double-lead threads over the body of the implant and 2mm of quadruple lead mini-threads near the coronal portion of the implant. The implant body features an even taper from the apical along its body and a straight walled coronal aspect. The implants offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface. InterActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments with up to 15° angulations .
InterActive 3.0 and 3.4mm straight titanium abutments, straight temporary abutments, and 15° angled titanium abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mm Length) implants.
## SwishPlus2 Dental Implants
The SwishPlus2 dental implant is a screw-type endosseous with an external thread configuration consisting of single lead threads over the body of the implant and 2mm of micro-grooves near the coronal portion of the implant. The implant body features an even taper at the apical end and a straight wall coronal aspect. The SwishPlus2 (two-stage) implant offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface diameters of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface. SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) titanium abutments with up to 15° angulations .
The InterActive/ SwishPlus2 implants are available with two surface coatings: SBM Blast and HA Coating
- ട്. Intended Use:
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Image /page/2/Picture/0 description: The image is a logo for Implant Direct. The logo features the words "Implant Direct" in bold, black letters, with the words "simply smarter" in smaller letters underneath. Below that, the words "Sybron Dental Specialties" are written. The logo is enclosed in a rounded rectangle.
| | Inter Active/Suich Piris 2 Imolant Sustem | |
|--|-------------------------------------------|--|
| | | |
InterActive/SwishPlus2 Implant System consists of two-piece implants for onestage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Reqular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
### Device Comparison (Technological Characteristics): 6.
This submission is comprised of devices whose physical dimensions, material composition, indications for use and methods of manufacture were previously cleared and have the same principles of operation as the cited predicate devices. The following Tables summarize the predicate device comparison analyses with the devices within the InterActive/SwishPlus2 Implant System. The subject device and the predicate devices have the same intended use, the same technological characteristics, implant/abutment interface, similar material and surface treatment.
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Implant Direct
Sybron Dental Speciality
nterActive/SwishPlus2 Implant System
Traditional 510(K) Submission
| Specific<br>Feature | InterActive and<br>SwishPlus2 | Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | Predicate Device:<br>Legacy+ (K090234) | Predicate Device:<br>SwissPlant<br>(K081396) | Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | Predicate Device:<br>Straumann<br>(K030007) | Substantial<br>Equivalence |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indications for Use | InterActive/SwishPlus2<br>Implant System consists of<br>two-piece implants for one-<br>stage or two-stage surgical<br>procedures. These implants<br>are intended for use in<br>partially and fully edentulous<br>upper and lower jaws in<br>support of single or multiple-<br>unit restorations and terminal<br>or intermediate abutment<br>support for fixed bridgework.<br>Implants can be indicated for<br>immediate loading when<br>good primary stability has<br>been achieved and with<br>appropriate occlusal<br>loading. Narrow Diameter<br>(3.2, 3.3mm): Indicated for<br>single-tooth replacement of<br>mandibular central and<br>lateral incisors and maxillary<br>lateral incisors. Also<br>indicated for multiple tooth<br>replacements or denture<br>stabilization. | Nobel Biocare's NobelActive implants<br>are endosseous implants intended to<br>be surgically placed in the bone of the<br>upper or lower jaw arches to provide<br>support for prosthetic devices, such as<br>an artificial tooth, in order to restore<br>patient esthetics and chewing function.<br>Nobel Biocare's NobelActive implants<br>are indicated for single or multiple unit<br>restorations in splinted or non-splinted<br>applications. Nobel Biocare's<br>NobelActive implants may be placed<br>immediately and put into immediate<br>function provided that initial stability<br>requirements detailed in the manual<br>are satisfied.<br><br>The NobelActive.3.0mm Implant Is<br>Indicated for use In the treatment of<br>missing maxillary lateral incisors or the<br>mandibular central and lateral incisors<br>to support prosthetic devices, such as<br>artificial teeth, In order to restore<br>chewing function in partially<br>edentulous patients. The NobelActive<br>3.0 implants may be put into<br>immediate function provided that<br>stability requirements detailed in the<br>manual are satisfied | Spectra-System Dental<br>Implants 2008 are<br>comprised of dental<br>implant fixtures and<br>prosthetic devices that<br>compose a two-piece<br>implant system. The<br>implants are intended for<br>use in the mandible and<br>maxilla, in support of<br>single unit or multiple<br>unit cement or screw-<br>receiving restorations<br>and for the retention and<br>support of overdentures.<br><br>The implants are<br>intended for immediate<br>placement and function<br>for the support of<br>singletooth or multiple-<br>tooth restorations,<br>recognizing bone<br>stability and appropriate<br>occusal load<br>requirements. | The SwissPlant<br>Dental Implant<br>system consists of<br>two-piece implants<br>for one or two-stage<br>surgical procedures<br>that are intended for<br>use in partially or fully<br>edentulous<br>mandibles and<br>maxillae, in support<br>of single or multiple-<br>unit restorations<br>including: cement<br>retained, screw<br>retained or<br>overdenture<br>restorations and in<br>terminal or immediate<br>abutment support for<br>fixed bridgework. The<br>SwissPlant dental<br>implants are intended<br>for immediate<br>placement and<br>function on single<br>tooth and/or | The 5.0 x 5.0mm<br>and the 6.0 x<br>5.0mm implants<br>are designed as a<br>one stage or two<br>stage surgical<br>procedure implant<br>for use in<br>edentulous sites in<br>the mandible or<br>maxilla for support<br>of a complete<br>denture prosthesis,<br>a terminal or<br>intermediate<br>abutment for fixed<br>bridgework, partial<br>dentures, or a<br>single tooth<br>replacement. | The ITI dental<br>implants are<br>intended for<br>immediate<br>placement and<br>function on single-<br>tooth and/or<br>multiple tooth<br>applications when<br>good primary<br>stability is achieved<br>and with<br>appropriate<br>occlusal loading, to<br>restore chewing<br>function. Multiple<br>tooth applications<br>may be rigidly<br>splinted. In the<br>case of edentulous<br>patients 4 or more<br>implants must be<br>used. | ✓ |
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nterActive/SwishPlus2 Implant System
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Implant Direct
sybron Dental Specialis
."
SwissPlus2 Implant System
| Traditional 510(K) Submission | | | | | |
|--------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------|
| InterActive/SwishPlus2 Dental Implants | | | | | |
| Specific<br>Feature | InterActive and<br>SwishPlus2 | 1. | Indications for Use (Cont'd) | Substantial<br>Equivalence | |
| | | Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | | | |
| | | Predicate Device:<br>Legacy+ (K090234) | multiple tooth<br>applications<br>recognizing initial<br>implant stability and<br>appropriate occlusal<br>loading, to restore<br>normal masticatory<br>function. | | |
| | | Predicate Device:<br>SwissPlant<br>(K081396) | | | |
| | | Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | The Bicon implant<br>is designed for use<br>in edentulous sites<br>in the mandible or<br>maxilla for support<br>of a complete<br>denture prosthesis,<br>a final or<br>intermediate<br>abutment for fixed<br>bridgework or for<br>partial dentures, or<br>as a single tooth<br>replacement. | | |
| | | Predicate Device:<br>Straumann<br>(K030007) | | may be rigidly<br>splinted. In case of<br>edentulous patients<br>4 or more implants<br>must be used. | |
| Specific<br>Feature | Indication | General<br>Design | Placement<br>Method | Material | Substantial<br>Equivalence |
| I. InterActive/SwishPlus2 Dental Implants | | | | | |
| InterActive and<br>SwishPlus2 | Immediate Load | Threaded groove, root form endosteal implant | Two stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | Immediate Load | Threaded groove, root form endosteal implant | Two stage surgery | CP Titanium Grade 4 | √ |
| Predicate Device:<br>Legacy+ (K090234) | Immediate Load | Threaded, root form implant | Two or single stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device:<br>SwissPlant<br>(K081396) | Immediate Load | Threaded, root form implant | Two or single stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | 10-12 weeks | Groove type implant | Two or single stage surgery | Titanium 6Al-4V | √ |
| Predicate Device:<br>Straumann<br>(K030007) | Immediate Load | Threaded, root form implant | Two or single stage surgery | CP Titanium Grade 4. Roxolid Ti-Zirconia Alloy | √ |
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Image /page/5/Picture/0 description: The image shows a logo for Implant Direct, a Sybron Dental Specialties company. The logo features the company name in bold, vertically stacked text. Below the company name is a curved line. The text "Simply Smarter" is also present in the logo.
terActive/SwishPlus2 Implant System ﺎ ﺍﻟﻤﺮﺍﺟﻊ ﺘ :
Traditional 510(K) Submission
---
ﻟﺘﺴﺮ
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Implant Direct.
Sybron Dental Speciality
nterActive/SwishPlus2 Implant System 1
"ve/Swish Plus2 Implant System
Traditional 510(K) Submission
| Specific<br>Feature | Implant Body Diameters and lengths | Interface<br>Name | | | Implant/<br>Abutment Interface | Engaging<br>Feature | Substantial<br>Equivalence |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----|--------------------------------------------------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| InterActive and<br>SwishPlus2 | InterActive:<br>3.2mm Dia. X 8-16mm L<br>3.7mm Dia, X 6-<br>16mm L<br>4.3mm Dia. X 6-<br>16mm L<br>5.0mm Dia. X 6-<br>16mm L<br>SwishPlus2:<br>3.3mm Dia. X 8-<br>16mm L<br>4.1mm Dia. X 6-<br>16mm L<br>4.8mm Dia. X 6-<br>16mm L<br>5.7mm Dia. X 6-<br>16mm L | 3.0 Platform, 3.4mm Platform | i. | InterActive/SwishPlus2 Dental Implants | | | |
| I. InterActive/SwishPlus2 Dental Implants | | | | InterActive and<br>SwishPlus2 | 3.0mm and 3.4mm | Single 2.3 hex with M1.6<br>threads,<br>Single 2.7mm hex with M2<br>threads | |
| Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | 3.0mm Dia. X 10-15mm L<br>3.5mm Dia.X 8.5-18mm L<br>4.3mm Dia.X 8.5-18mm L<br>5.0mm Dia.X 8.5-18mm L | 3.0 Platform, NP, RP | | Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | 2.5mm, 3.0mm, 3.4mm | Single < 2.3mm hex with M1.6<br>threads,<br>Single 2.3 hex with M1.6 threads,<br>Single 2.7mm hex with M2 threads | |
| Predicate Device:<br>Legacy+ (K090234) | 3.2mm Dia. X<br>8-16mm L<br>3.7mm Dia. X<br>8-16mm L<br>4.2mm Dia. X<br>8-16mm L<br>4.7mm Dia. X<br>8-16mm L<br>5.2mm Dia. X<br>8-16mm L<br>5.7mm Dia. X<br>8-16mm L | 3.0mm, 3.5mm,4.5mm,<br>5.7mm | | Predicate Device:<br>Legacy+ (K090234) | 3.0mm, 3.5mm,4.5mm,<br>5.7mm | 2.0mm and 2.25mm hex<br>with M1.6 threads,<br>2.5mm hex with 1-72<br>thread,<br>3.0mm hex with 1-72<br>threads | |
| Predicate Device:<br>Swiss Plant<br>(K081396) | 4.1mm Dia.<br>6-16mm L<br>4.8mm Dia.<br>6-16mm L | 4.8mm and 6.5mm | | Predicate Device:<br>SwissPlant<br>(K081396) | 4.8mm and 6.5mm | 3.10mm Octagon<br>with M2 threads | |
| Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | Ø3.0mm<br>x 8mmL<br>Ø 3.5mm<br>x 8-<br>11mmL<br>Ø4.0mm<br>x 5-<br>11mmL<br>Ø4.5mm<br>x 6-<br>11mmL<br>Ø5.0mm<br>x 5-<br>11mmL<br>Ø6.0mm<br>x 5-8mmL | 2.0, 2.5, 3.0mm<br>Well | | Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | 2.0, 2.5, 3.0mm | Single 2.0. 2.5,<br>and 3.0mm<br>Internal Taper<br>Lock with friction fit<br>for antirotation and<br>retention | |
| Predicate Device:<br>Straumann<br>(K030007) | 3.3mm x<br>8-14mmL<br>(3.5mm<br>Platform)<br>3.3mm x 8-14mmL<br>(4.8mm Platform)<br>4.1mm x 6-14mmL<br>(4.8mm Platform)<br>4.8mm x 6-14mmL<br>(4.8mm Platform)<br>4.8mm x 6-14mmL<br>(6.5mm Platform) | 4.8 and 6.5mm<br>Platforms | | Predicate Device:<br>Straumann<br>(K030007) | 4.8 and 6.5mm | Single 3.1mm<br>Internal Octagon<br>with M2 Threads for<br>retention | ✓ |
| | | Substantial<br>Equivalence | | | | | |
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Implant Direct
sybron Dental Specialtics
ィッ
terActive/SwishPlus2 Implant System
Traditional 510(K) Submission
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Image /page/8/Picture/1 description: The image contains the text 'nterActive/SwishPlus2 Implant System'. The text is vertically oriented and appears to be the title or label for a product or system. The presence of 'Implant System' suggests it is related to medical or dental implants. The rest of the image is filled with colons and periods.
| Specific<br>Feature | InterActive and<br>SwishPlus2 | Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | Predicate Device:<br>Legacy+ (K090234) | Predicate Device:<br>SwissPlant<br>(K081396) | Predicate Device:<br>Bicon Implants<br>(K073368 and<br>K092035) | Predicate Device:<br>Straumann<br>(K030007) | Substantial<br>Equivalence |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|----------------------------|
| Surface Treatment | SBM : Soluable Blasted<br>Media surface with<br>roughness between 1.5 μm<br>and 2.3 μm<br>or<br>HA: Soluable Blasted Media<br>surface with roughness<br>between 1.5 μm and 2.3 μm<br>at 3.5mm coronal section and<br>HA coated surface with<br>thickness of 5-15 microns on<br>the rest of the body length | TiUnite: Nobel Biocare's proprietary<br>titanium oxide dental implant surface | SBM : Soluable Blasted<br>Media surface with<br>roughness between 1.5<br>μm and 2.3 μm<br>or<br>HA: Soluable Blasted<br>Media surface with<br>roughness between 1.5<br>μm and 2.3 μm at 3mm<br>coronal section and HA<br>coated surface with<br>thickness of 35-60<br>microns on the rest of<br>the body length | SBM: Dual Soluable<br>Blasted Media<br>surface with<br>roughness between<br>0.3 μm and 0.9 μm in<br>the collar section and<br>1.5 μm and 2.3 μm in<br>the body section | Integra-Ti and<br>Integra-CP | SLA and SLActive | ✓ |
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Image /page/9/Picture/5 description: The image is a logo for Implant Direct, a Sybron Dental Specialties company. The logo is vertically oriented and features the company name in bold, sans-serif font. Below the company name is a curved line, and to the right of the company name is the text "Simply Smarter" and "Sybron Dental Specialties" in a smaller font.
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| Specific<br>Feature | | Predicate Device:<br>Legacy+ (K090234) | Predicate Device:<br>SwissPlant (K081396) | Predicate Device:<br>Bicon Implants<br>(K073368 and K092035) | Predicate Device:<br>Straumann (K030007) | Substantial<br>Equivalence |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------|------------------------------------------|----------------------------|
| | <i>I.</i><br>InterActive/SwishPlus2 Dental Implants | | | | | |
| InterActive and<br>SwishPlus2 | Predicate Device NobelActive 3.0<br>(K102436) & NobelActive NP/RP<br>(K071370) | N/A | N/A | N/A | N/A | √ |
| Compatibility with Abutments | Prosthetically compatible with<br>InterActive 3.0 and 3.4mm<br>abutments and Nobel<br>Biocare conical connection<br>NobelActive™ NP (Narrow<br>Platform – 3.0mm diameter)<br>and NobelActive™ RP<br>(Regular Platform – 3.4mm<br>diameter) abutments | Nobel Biocare conical connection<br>NobelActive™ NP (Narrow Platform –<br>3.0mm diameter) and NobelActive™<br>RP (Regular Platform – 3.4mm<br>diameter) abutments | N/A | N/A | N/A | |
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、どんなこと
Image /page/10/Picture/1 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "simply smarter" underneath. Below the company name is "Sybron Dental Specialties". The logo is enclosed in a black border.
| +<br>1 | | |
|--------|------------------------------------------|--|
| | | |
| | nter Schivel Swish Plus 2 Imniant System | |
Traditional 510(K) Submission
: 上一篇:
. .
| II. | Cement Retained Angled Contoured Abutments | | |
|-------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------|
| Technological Characteristics | InterActive Cement<br>Retained Angled<br>Abutments | Predicate Devices:<br>36668, 36673<br>(K071370) | Substantial<br>Equivalence |
| Intended Use | To be used as a post to<br>support the cemented<br>prostheses for single or<br>multiple restorations | To be used as a post to<br>support the cemented<br>prostheses for single or<br>multiple restorations | √ |
| General Design | 2.3 or 2.7 mm hex<br>engaging feature with a<br>15 degree post and a<br>prosthetic margin | 2.3 or 2.7mm hex engaging<br>feature with a 15 degree<br>post and a prosthetic margin | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Platform | 3.0, 3.4mm | 3.0, 3.4mm | √ |
### Cement Retained Straight and Straight Contour Abutments III.
| Technological Characteristics | InterActive Cement Retained Straight Abutments | Predicate Devices:<br>P/N 36665, 36669<br>(K071370) | Substantial Equivalence |
|-------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------|
| Intended Use | To be used as a post to support the cemented prostheses for single or multiple restorations | To be used as a post to support the cemented prostheses for single or multiple restorations | √ |
| General Design | 2.3 or 2.7mm hex engaging feature with a straight post and a prosthetic margin | 2.3 or 2.7mm hex engaging feature with a straight post and a prosthetic margin | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0-3.4mm | 3.0-3.4mm | √ |
: 1. 1. 1. 1. 1. . -
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Image /page/11/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "simply smarter" underneath. Below that is the text "Sybron Dental Specialties". The logo is enclosed in a rounded rectangle.
| . . | V | | |
|-----|---|---------------------------------------|--|
| - | | | |
| . . | | | |
| | | InterActive/SwishPlus2 Implant System | |
1
| IV. | Screw-Receiving Overdenture Abutments | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Technological Characteristics | InterActive<br>Screw-Receiving<br>Overdenture Abutments | Predicate Devices:<br>P/N 36611, 36616<br>(K071370) | Substantial<br>Equivalence |
| Intended Use | To be used as a<br>transmucosal extension for<br>the fabrication of screw-<br>retained multiple-unit<br>prosthesis | To be used as a<br>transmucosal extension for<br>the fabrication of screw-<br>retained multiple-unit<br>prosthesis | √ |
| General Design | Screw-in abutment that<br>does not engage the<br>internal hex connection of<br>the implant | Screw-in abutment that<br>does not engage the<br>internal hex connection of<br>the implant | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0, 3.4mm | √ |
| V. | Screw Receiving Overdenture Angled Abutments with Optional Ball Tops | | |
| Technological Characteristics | InterActive<br>Screw-Receiving<br>Overdenture Angled<br>Abutments with optional<br>Ball Tops | Predicate Devices:<br>P/N 6035-65-30<br>(K081101) | Substantial<br>Equivalence |
| Intended Use | To be used as a<br>transmucosal extension for<br>the fabrication of screw-<br>retained multiple-unit<br>prosthesis | To be used as a<br>transmucosal extension for<br>the fabrication of screw-<br>retained multiple-unit<br>prosthesis | √ |
| General Design | Implant engaging feature<br>with a 30 degree angled<br>base and a threaded top to<br>received the overdenture<br>prosthetics | Implant engaging feature<br>with 30 degree angled<br>base and a threaded top to<br>received the overdenture<br>prosthetics | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.5 - 6.0 mm | √ |
| VI. | Gold Engaging Abutments | | |
| Technological Characteristics | InterActive<br>Gold Engaging<br>Abutments | Predicate Devices:<br>P/N 36728, 36729<br>(K071370) | Substantial<br>Equivalence |
| Intended Use | To be used as a castable | To be used as a castable | |
T
- .
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Image /page/12/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "simply smarter." written in a smaller font below. The text "Sybron Dental Specialties" is written below the tagline. A black curved line is above the company name.
## nterActive/SwishPlus2 Implant System
3.0mm
:
く
: -
።
. ' '
| | | Traditional 510(K) Submission | |
|----------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------|
| | abutment for single or<br>multiple restorations | abutment for single or<br>multiple restorations | √ |
| General Design | Gold cylinder with hex<br>engaging feature and<br>castable plastic sheath | Gold cylinder with hex<br>engaging feature and<br>castable plastic sheath | √ |
| Material | Gold Alloy 6019 | Gold Alloy 6019 | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0, 3.4mm | √ |
| VII. Gold Non-Engaging Abutments | | | |
| Technological Characteristics | InterActive<br>Gold None-Engaging<br>Abutments | Predicate Devices:<br>P/N 36726, 36727<br>(K071370) | Substantial<br>Equivalence |
| Intended Use | To be used as a castable<br>abutment for single or<br>multiple restorations | To be used as a castable<br>abutment for single or<br>multiple restorations | √ |
| General Design | Gold cylinder with castable<br>plastic sheath | Gold cylinder with castable<br>plastic sheath | √ |
| Material | Gold Alloy 6019 | Gold Alloy 6019 | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.4 - 3.9/ 3.4 - 6mm | √ |
| VIII. Ball Abutments | | | |
| Technological Characteristics | InterActive<br>Ball Abutments | Predicate Device:<br>8530-71<br>(K090234) | Substantial<br>Equivalence |
| Intended Use | To be used for cap<br>attachment overdenture<br>applications | To be used for cap<br>attachment overdenture<br>applications | √ |
| General Design | Ball receiving cap<br>attachment systems with<br>thread engaging feature | Ball receiving cap<br>attachment systems with<br>thread engaging feature | √ |
| Material | Titanium alloy | Titanium alloy | √ |
### ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . IX. Straight Full Contour Abutments
Implant/abut Interface
| Technological Characteristics | InterActive<br>Straight Full Contour<br>Abutments | Predicate Devices:<br>P/N 8530-30L<br>(K090234) | Substantial<br>Equivalence |
|-------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | To be used as a post to<br>support the cemented<br>prostheses for single or<br>multiple restorations | To be used as a post to<br>support the cemented<br>prostheses for single or<br>multiple restorations | √ |
| General Design | 2.3, 2.7mm hex engaging<br>feature with a straight post | 2.0mm hex engaging<br>feature with a straight post | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0mm | √ |
3.0, 3.4mm
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Image /page/13/Picture/0 description: The image shows the logo for Implant Direct. The logo has the words "Implant Direct" in bold black letters with the tagline "simply smarter" in a smaller font below. Underneath that is the text "Sybron Dental Specialties".
| InterActive/SwishPlus2 Implant System | | |
|---------------------------------------|--|--|
| Technological Characteristics | InterActive<br>Temporary Plastic<br>Abutments | Predicate Devices:<br>P/N 8530-47<br>(K090234) | Substantial<br>Equivalence |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | To be used as a temporary<br>post to support the<br>provisional prostheses for<br>single or multiple<br>restorations | To be used as a temporary<br>post to support the<br>cemented prostheses for<br>single or multiple<br>restorations | √ |
| General Design | 2.3-2.7mm hex engaging<br>feature with a straight post | 2.0mm hex engaging<br>feature with a straight post | √ |
| Material | PEEK | PEEK | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0mm | √ |
### Temporary Titanium Non-Engaging Abutments XI.
| Technological Characteristics | InterActive<br>Temporary Titanium<br>Abutments | Predicate Devices:<br>P/N 36661 and 36662<br>(K071370) | Substantial<br>Equivalence |
|-------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | To be used as a temporary<br>post to support the<br>provisional prostheses for<br>multiple restorations | To be used as a temporary<br>post to support the<br>provisional prostheses for<br>multiple restorations | √ |
| General Design | 3.0 - 3.4 non-engaging<br>interface with a straight<br>post | 3.0 - 3.4 non-engaging<br>interface with a straight<br>post | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0, 3.4mm | √ |
The InterActive/SwishPlus2 implants were shown to be substantially equivalent to the predicate devices:
### 7. Non-clinical Performance Testing:
The devices in this submission have mechanical safety (strength) equivalent to the predicate devices. Laboratory testing was conducted for the worst-case devices following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801 in static compression bending and fatigue, as well as implant driving torque and abutment/screw torque to failure tests. The components have shown to exhibit equivalent mechanical strength as the predicate devices and the implant/abutment combinations were able to withstand loads that were higher than the functional masticatory loads. Sterilization Validation was carried out in accordance with ISO 17665 -1&2 meeting the requirements and complying with the standards.
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Image /page/14/Picture/0 description: The image shows a logo for Implant Direct. The logo has the words "Implant Direct" in bold black letters. Below that, in smaller letters, it says "simply smarter." Underneath that, it says "Sybron Dental Specialties".
Image /page/14/Figure/1 description: The image shows the text 'InterActive/SwishPlus2 Implant System'. The text is in a simple font and is located at the bottom of the image. The background of the image is white, and the text is black.
### Clinical Performance Testing 8.
No clinical testing was performed. The clinical evaluation was used to support this decision.
#### Conclusion: 9.
The information submitted in this 510(k) for the interActive/SwishPlus2 Implant System have shown that the devices are substantial equivalent to the device systems identified as predicates and it is considered that the new devices are compatible and perform as well as the predicate device.
{15}------------------------------------------------
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, with three abstract figures representing the human form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
Implant Direct Sybron Manufacturing LLC Ms. Ines Aravena Senior Director of Product Design and Regulatory Affairs 27030 Malibu Hills Road CALABASAS HILLS, CA 91301
Re: K130572
Trade/Device Name: InterActive / SwishPlus 2 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 25, 2013 Received: November 26, 2013
Dear Ms. Aravena:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Aravena
· Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
**Kwame Q. Ulmer**
-s FDA
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/17/Picture/0 description: The image is a logo for Implant Direct, a dental company. The logo features the company name in bold, black letters, with the tagline "our simply smarter" underneath. Below that is "Sybron Dental Specialties". The logo is surrounded by a black oval shape.
Image /page/17/Picture/1 description: The image shows a rectangular box with the text "InterActive/Swish Plus2 Implant System" written on the bottom. The text is in a sans-serif font and is black. The background of the box is white. The text is slightly blurry, but still legible.
# Indications for Use
510(k) Number (if known): K130572
Device Name: InterActive/SwishPlus2 Implant System
Indications for Use:
InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Runge
Mary S. Runner -S
DOS, M. 2013.12.23
11 08:09:12 -05'00'
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