(295 days)
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.
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).
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.
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.
The InterActive/ SwishPlus2 implants are available with two surface coatings: SBM Blast and HA Coating.
Here's an analysis of the acceptance criteria and supporting studies for the InterActive/SwishPlus2 Implant System, based on the provided 510(k) summary:
The InterActive/SwishPlus2 Implant System is a dental implant system. The application does not describe an AI/ML device.
Therefore, most of the requested information (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission. The 510(k) primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a dental implant device and not an AI/ML system, "acceptance criteria" here refers to demonstrating substantial equivalence to predicate devices across various technological characteristics and meeting relevant mechanical safety standards. There isn't a direct "performance metric" in the way one would define it for an AI/ML model (e.g., accuracy, sensitivity, AUC). Instead, performance is demonstrated by meeting or exceeding the mechanical properties of the predicate devices.
| Feature / Acceptance Criteria Category | Reported Device Performance (as demonstrated by comparison or testing) |
|---|---|
| Indications for Use | Substantially equivalent to multiple predicate devices. Intended for use in partially and fully edentulous upper and lower jaws for single or multiple-unit restorations, fixed bridgework support, and immediate loading when primary stability is achieved. Narrow diameter implants are indicated for specific single or multiple tooth replacements and denture stabilization. |
| Material | InterActive and SwishPlus2 implants: Titanium 6Al-4V ELI (Substantially equivalent to predicate devices including CP Titanium Grade 4 and Titanium 6Al-4V). Various abutments: Titanium alloy or Gold Alloy 6019. Temporary abutments: PEEK or Titanium alloy. |
| General Design (Implants) | Threaded groove, root form endosteal implant (Substantially equivalent to predicate devices). InterActive: tapered screw-type with double-lead and mini-threads. SwishPlus2: screw-type with single lead and micro-grooves. Both have conical leading bevel and internal hex. |
| Placement Method | Two-stage surgery (Substantially equivalent to predicate devices, some of which also allow single-stage). |
| Surface Treatment | SBM (Soluble Blasted Media) with roughness between 1.5-2.3 μm or HA (Hydroxyapatite) coated surface (Substantially equivalent to predicate devices including TiUnite, SBM, HA, Integra-Ti, Integra-CP, SLA, SLActive). |
| Implant Body Diameters & Lengths | Varying diameters (3.2mm to 5.7mm) and lengths (6mm to 16mm) provided, comparable to ranges offered by predicate devices. |
| Interface Name & Diameters | 3.0 Platform, 3.4mm Platform (identical to NobelActive implants' NP and RP interfaces). |
| Engaging Feature (Implants) | Single 2.3 hex with M1.6 threads, Single 2.7mm hex with M2 threads (comparable to predicate devices). |
| Compatibility with Abutments | Prosthetically compatible with InterActive 3.0/3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP/RP abutments. |
| Mechanical Safety (Strength) | Devices have mechanical safety (strength) equivalent to predicate devices, able to withstand loads higher than functional masticatory loads as per FDA guidance and ISO 14801 in static compression bending, fatigue, implant driving torque, and abutment/screw torque to failure tests. |
| Sterilization Validation | Validated in accordance with ISO 17665 -1&2. |
2. Sample Sizes Used for the Test Set and Data Provenance
This is not an AI/ML device, so there is no "test set" in that context. The "testing" involved non-clinical performance and mechanical safety testing on the device prototypes/samples. The document does not specify the exact number of units tested for each mechanical test, but mentions "worst-case devices."
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, located in Calabasas Hills, CA, USA. This is not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is not an AI/ML device requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO 14801 for mechanical properties of dental implants).
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are typically evaluated against pre-defined engineering thresholds and standards, not through expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The Type of Ground Truth Used
For the non-clinical performance testing (mechanical strength, fatigue, torque tests), the "ground truth" is derived from established international and FDA-recognized engineering standards and guidance documents, specifically:
- FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments"
- ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants)
- ISO 17665 -1&2 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
The device's performance is compared against the performance of similar predicate devices (physical products) that have already been cleared by the FDA.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device. There is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study to demonstrate the device meets acceptance criteria was a non-clinical performance testing program. This program involved:
- Mechanical Safety (Strength) Testing: Conducted on "worst-case devices" following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. This included:
- Static compression bending tests
- Fatigue tests
- Implant driving torque tests
- Abutment/screw torque to failure tests
The results showed that the components exhibited equivalent mechanical strength to the predicate devices and that the implant/abutment combinations could withstand loads higher than functional masticatory loads.
- Sterilization Validation: Carried out in accordance with ISO 17665 -1&2, meeting the requirements and complying with the standards.
- Substantial Equivalence Comparison: Detailed comparison of the InterActive/SwishPlus2 Implant System's technological characteristics (indications for use, general design, placement method, material, surface treatment, body dimensions, interface, engaging features, and abutment compatibility) against multiple legally marketed predicate devices (e.g., NobelActive 3.0, NobelActive Internal Connection Implants, Spectra-System Dental Implants, SwissPlant Dental Implant System, Bicon Implants, Straumann ITI Dental Implant System). The submission argues that the new device has the same intended use, same technological characteristics, implant/abutment interface, and similar materials and surface treatments as the predicates.
No clinical testing was performed; the decision was supported by clinical evaluation based on the established safety and effectiveness of the predicate devices and the documented substantial equivalence.
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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))
- 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
| SpecificFeature | InterActive andSwishPlus2 | Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | Predicate Device:Legacy+ (K090234) | Predicate Device:SwissPlant(K081396) | Predicate Device:Bicon Implants(K073368 andK092035) | Predicate Device:Straumann(K030007) | SubstantialEquivalence |
|---|---|---|---|---|---|---|---|
| Indications for Use | InterActive/SwishPlus2Implant System consists oftwo-piece implants for one-stage or two-stage surgicalprocedures. These implantsare intended for use inpartially and fully edentulousupper and lower jaws insupport of single or multiple-unit restorations and terminalor intermediate abutmentsupport for fixed bridgework.Implants can be indicated forimmediate loading whengood primary stability hasbeen achieved and withappropriate occlusalloading. Narrow Diameter(3.2, 3.3mm): Indicated forsingle-tooth replacement ofmandibular central andlateral incisors and maxillarylateral incisors. Alsoindicated for multiple toothreplacements or denturestabilization. | Nobel Biocare's NobelActive implantsare endosseous implants intended tobe surgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, such asan artificial tooth, in order to restorepatient esthetics and chewing function.Nobel Biocare's NobelActive implantsare indicated for single or multiple unitrestorations in splinted or non-splintedapplications. Nobel Biocare'sNobelActive implants may be placedimmediately and put into immediatefunction provided that initial stabilityrequirements detailed in the manualare satisfied.The NobelActive.3.0mm Implant IsIndicated for use In the treatment ofmissing maxillary lateral incisors or themandibular central and lateral incisorsto support prosthetic devices, such asartificial teeth, In order to restorechewing function in partiallyedentulous patients. The NobelActive3.0 implants may be put intoimmediate function provided thatstability requirements detailed in themanual are satisfied | Spectra-System DentalImplants 2008 arecomprised of dentalimplant fixtures andprosthetic devices thatcompose a two-pieceimplant system. Theimplants are intended foruse in the mandible andmaxilla, in support ofsingle unit or multipleunit cement or screw-receiving restorationsand for the retention andsupport of overdentures.The implants areintended for immediateplacement and functionfor the support ofsingletooth or multiple-tooth restorations,recognizing bonestability and appropriateoccusal loadrequirements. | The SwissPlantDental Implantsystem consists oftwo-piece implantsfor one or two-stagesurgical proceduresthat are intended foruse in partially or fullyedentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding: cementretained, screwretained oroverdenturerestorations and interminal or immediateabutment support forfixed bridgework. TheSwissPlant dentalimplants are intendedfor immediateplacement andfunction on singletooth and/or | The 5.0 x 5.0mmand the 6.0 x5.0mm implantsare designed as aone stage or twostage surgicalprocedure implantfor use inedentulous sites inthe mandible ormaxilla for supportof a completedenture prosthesis,a terminal orintermediateabutment for fixedbridgework, partialdentures, or asingle toothreplacement. | The ITI dentalimplants areintended forimmediateplacement andfunction on single-tooth and/ormultiple toothapplications whengood primarystability is achievedand withappropriateocclusal loading, torestore chewingfunction. Multipletooth applicationsmay be rigidlysplinted. In thecase of edentulouspatients 4 or moreimplants must beused. | ✓ |
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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 | |||||
| SpecificFeature | InterActive andSwishPlus2 | 1. | Indications for Use (Cont'd) | SubstantialEquivalence | |
| Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | |||||
| Predicate Device:Legacy+ (K090234) | multiple toothapplicationsrecognizing initialimplant stability andappropriate occlusalloading, to restorenormal masticatoryfunction. | ||||
| Predicate Device:SwissPlant(K081396) | |||||
| Predicate Device:Bicon Implants(K073368 andK092035) | The Bicon implantis designed for usein edentulous sitesin the mandible ormaxilla for supportof a completedenture prosthesis,a final orintermediateabutment for fixedbridgework or forpartial dentures, oras a single toothreplacement. | ||||
| Predicate Device:Straumann(K030007) | may be rigidlysplinted. In case ofedentulous patients4 or more implantsmust be used. | ||||
| SpecificFeature | Indication | GeneralDesign | PlacementMethod | Material | SubstantialEquivalence |
| I. InterActive/SwishPlus2 Dental Implants | |||||
| InterActive andSwishPlus2 | Immediate Load | Threaded groove, root form endosteal implant | Two stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | Immediate Load | Threaded groove, root form endosteal implant | Two stage surgery | CP Titanium Grade 4 | √ |
| Predicate Device:Legacy+ (K090234) | Immediate Load | Threaded, root form implant | Two or single stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device:SwissPlant(K081396) | Immediate Load | Threaded, root form implant | Two or single stage surgery | Titanium 6Al-4V ELI | √ |
| Predicate Device:Bicon Implants(K073368 andK092035) | 10-12 weeks | Groove type implant | Two or single stage surgery | Titanium 6Al-4V | √ |
| Predicate Device:Straumann(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
| SpecificFeature | Implant Body Diameters and lengths | InterfaceName | Implant/Abutment Interface | EngagingFeature | SubstantialEquivalence | ||
|---|---|---|---|---|---|---|---|
| InterActive andSwishPlus2 | InterActive:3.2mm Dia. X 8-16mm L3.7mm Dia, X 6-16mm L4.3mm Dia. X 6-16mm L5.0mm Dia. X 6-16mm LSwishPlus2:3.3mm Dia. X 8-16mm L4.1mm Dia. X 6-16mm L4.8mm Dia. X 6-16mm L5.7mm Dia. X 6-16mm L | 3.0 Platform, 3.4mm Platform | i. | InterActive/SwishPlus2 Dental Implants | |||
| I. InterActive/SwishPlus2 Dental Implants | InterActive andSwishPlus2 | 3.0mm and 3.4mm | Single 2.3 hex with M1.6threads,Single 2.7mm hex with M2threads | ||||
| Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | 3.0mm Dia. X 10-15mm L3.5mm Dia.X 8.5-18mm L4.3mm Dia.X 8.5-18mm L5.0mm Dia.X 8.5-18mm L | 3.0 Platform, NP, RP | Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | 2.5mm, 3.0mm, 3.4mm | Single < 2.3mm hex with M1.6threads,Single 2.3 hex with M1.6 threads,Single 2.7mm hex with M2 threads | ||
| Predicate Device:Legacy+ (K090234) | 3.2mm Dia. X8-16mm L3.7mm Dia. X8-16mm L4.2mm Dia. X8-16mm L4.7mm Dia. X8-16mm L5.2mm Dia. X8-16mm L5.7mm Dia. X8-16mm L | 3.0mm, 3.5mm,4.5mm,5.7mm | Predicate Device:Legacy+ (K090234) | 3.0mm, 3.5mm,4.5mm,5.7mm | 2.0mm and 2.25mm hexwith M1.6 threads,2.5mm hex with 1-72thread,3.0mm hex with 1-72threads | ||
| Predicate Device:Swiss Plant(K081396) | 4.1mm Dia.6-16mm L4.8mm Dia.6-16mm L | 4.8mm and 6.5mm | Predicate Device:SwissPlant(K081396) | 4.8mm and 6.5mm | 3.10mm Octagonwith M2 threads | ||
| Predicate Device:Bicon Implants(K073368 andK092035) | Ø3.0mmx 8mmLØ 3.5mmx 8-11mmLØ4.0mmx 5-11mmLØ4.5mmx 6-11mmLØ5.0mmx 5-11mmLØ6.0mmx 5-8mmL | 2.0, 2.5, 3.0mmWell | Predicate Device:Bicon Implants(K073368 andK092035) | 2.0, 2.5, 3.0mm | Single 2.0. 2.5,and 3.0mmInternal TaperLock with friction fitfor antirotation andretention | ||
| Predicate Device:Straumann(K030007) | 3.3mm x8-14mmL(3.5mmPlatform)3.3mm x 8-14mmL(4.8mm Platform)4.1mm x 6-14mmL(4.8mm Platform)4.8mm x 6-14mmL(4.8mm Platform)4.8mm x 6-14mmL(6.5mm Platform) | 4.8 and 6.5mmPlatforms | Predicate Device:Straumann(K030007) | 4.8 and 6.5mm | Single 3.1mmInternal Octagonwith M2 Threads forretention | ✓ | |
| SubstantialEquivalence |
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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.
| SpecificFeature | InterActive andSwishPlus2 | Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | Predicate Device:Legacy+ (K090234) | Predicate Device:SwissPlant(K081396) | Predicate Device:Bicon Implants(K073368 andK092035) | Predicate Device:Straumann(K030007) | SubstantialEquivalence |
|---|---|---|---|---|---|---|---|
| Surface Treatment | SBM : Soluable BlastedMedia surface withroughness between 1.5 μmand 2.3 μmorHA: Soluable Blasted Mediasurface with roughnessbetween 1.5 μm and 2.3 μmat 3.5mm coronal section andHA coated surface withthickness of 5-15 microns onthe rest of the body length | TiUnite: Nobel Biocare's proprietarytitanium oxide dental implant surface | SBM : Soluable BlastedMedia surface withroughness between 1.5μm and 2.3 μmorHA: Soluable BlastedMedia surface withroughness between 1.5μm and 2.3 μm at 3mmcoronal section and HAcoated surface withthickness of 35-60microns on the rest ofthe body length | SBM: Dual SoluableBlasted Mediasurface withroughness between0.3 μm and 0.9 μm inthe collar section and1.5 μm and 2.3 μm inthe body section | Integra-Ti andIntegra-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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| SpecificFeature | Predicate Device:Legacy+ (K090234) | Predicate Device:SwissPlant (K081396) | Predicate Device:Bicon Implants(K073368 and K092035) | Predicate Device:Straumann (K030007) | SubstantialEquivalence | |
|---|---|---|---|---|---|---|
| I.InterActive/SwishPlus2 Dental Implants | ||||||
| InterActive andSwishPlus2 | Predicate Device NobelActive 3.0(K102436) & NobelActive NP/RP(K071370) | N/A | N/A | N/A | N/A | √ |
| Compatibility with Abutments | Prosthetically compatible withInterActive 3.0 and 3.4mmabutments and NobelBiocare conical connectionNobelActive™ NP (NarrowPlatform – 3.0mm diameter)and NobelActive™ RP(Regular Platform – 3.4mmdiameter) abutments | Nobel Biocare conical connectionNobelActive™ NP (Narrow Platform –3.0mm diameter) and NobelActive™RP (Regular Platform – 3.4mmdiameter) 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.
| +1 | ||
|---|---|---|
| nter Schivel Swish Plus 2 Imniant System |
Traditional 510(K) Submission
: 上一篇:
. .
| II. | Cement Retained Angled Contoured Abutments | ||
|---|---|---|---|
| Technological Characteristics | InterActive CementRetained AngledAbutments | Predicate Devices:36668, 36673(K071370) | SubstantialEquivalence |
| Intended Use | To be used as a post tosupport the cementedprostheses for single ormultiple restorations | To be used as a post tosupport the cementedprostheses for single ormultiple restorations | √ |
| General Design | 2.3 or 2.7 mm hexengaging feature with a15 degree post and aprosthetic margin | 2.3 or 2.7mm hex engagingfeature with a 15 degreepost 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:P/N 36665, 36669(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 | InterActiveScrew-ReceivingOverdenture Abutments | Predicate Devices:P/N 36611, 36616(K071370) | SubstantialEquivalence |
| Intended Use | To be used as atransmucosal extension forthe fabrication of screw-retained multiple-unitprosthesis | To be used as atransmucosal extension forthe fabrication of screw-retained multiple-unitprosthesis | √ |
| General Design | Screw-in abutment thatdoes not engage theinternal hex connection ofthe implant | Screw-in abutment thatdoes not engage theinternal hex connection ofthe 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 | InterActiveScrew-ReceivingOverdenture AngledAbutments with optionalBall Tops | Predicate Devices:P/N 6035-65-30(K081101) | SubstantialEquivalence |
| Intended Use | To be used as atransmucosal extension forthe fabrication of screw-retained multiple-unitprosthesis | To be used as atransmucosal extension forthe fabrication of screw-retained multiple-unitprosthesis | √ |
| General Design | Implant engaging featurewith a 30 degree angledbase and a threaded top toreceived the overdentureprosthetics | Implant engaging featurewith 30 degree angledbase and a threaded top toreceived the overdentureprosthetics | √ |
| Material | Titanium alloy | Titanium alloy | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.5 - 6.0 mm | √ |
| VI. | Gold Engaging Abutments | ||
| Technological Characteristics | InterActiveGold EngagingAbutments | Predicate Devices:P/N 36728, 36729(K071370) | SubstantialEquivalence |
| 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 ormultiple restorations | abutment for single ormultiple restorations | √ | |
| General Design | Gold cylinder with hexengaging feature andcastable plastic sheath | Gold cylinder with hexengaging feature andcastable 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 | InterActiveGold None-EngagingAbutments | Predicate Devices:P/N 36726, 36727(K071370) | SubstantialEquivalence |
| Intended Use | To be used as a castableabutment for single ormultiple restorations | To be used as a castableabutment for single ormultiple restorations | √ |
| General Design | Gold cylinder with castableplastic sheath | Gold cylinder with castableplastic 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 | InterActiveBall Abutments | Predicate Device:8530-71(K090234) | SubstantialEquivalence |
| Intended Use | To be used for capattachment overdentureapplications | To be used for capattachment overdentureapplications | √ |
| General Design | Ball receiving capattachment systems withthread engaging feature | Ball receiving capattachment systems withthread engaging feature | √ |
| Material | Titanium alloy | Titanium alloy | √ |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . IX. Straight Full Contour Abutments
Implant/abut Interface
| Technological Characteristics | InterActiveStraight Full ContourAbutments | Predicate Devices:P/N 8530-30L(K090234) | SubstantialEquivalence |
|---|---|---|---|
| Intended Use | To be used as a post tosupport the cementedprostheses for single ormultiple restorations | To be used as a post tosupport the cementedprostheses for single ormultiple restorations | √ |
| General Design | 2.3, 2.7mm hex engagingfeature with a straight post | 2.0mm hex engagingfeature 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 | InterActiveTemporary PlasticAbutments | Predicate Devices:P/N 8530-47(K090234) | SubstantialEquivalence |
|---|---|---|---|
| Intended Use | To be used as a temporarypost to support theprovisional prostheses forsingle or multiplerestorations | To be used as a temporarypost to support thecemented prostheses forsingle or multiplerestorations | √ |
| General Design | 2.3-2.7mm hex engagingfeature with a straight post | 2.0mm hex engagingfeature with a straight post | √ |
| Material | PEEK | PEEK | √ |
| Implant/abut Interface | 3.0, 3.4mm | 3.0mm | √ |
Temporary Titanium Non-Engaging Abutments XI.
| Technological Characteristics | InterActiveTemporary TitaniumAbutments | Predicate Devices:P/N 36661 and 36662(K071370) | SubstantialEquivalence |
|---|---|---|---|
| Intended Use | To be used as a temporarypost to support theprovisional prostheses formultiple restorations | To be used as a temporarypost to support theprovisional prostheses formultiple restorations | √ |
| General Design | 3.0 - 3.4 non-engaginginterface with a straightpost | 3.0 - 3.4 non-engaginginterface with a straightpost | √ |
| 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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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'
Page 1 of 1
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.