Predicate Devices

K102436, K071370, K090234, K081101, K081396, K061319, K092035, K073368, K030007

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a dental implant system and its mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing and sterilization validation.

Therapeutic

Yes
The device is described as an implant system intended for use in the jaws to support dental restorations, which directly addresses a medical condition (edentulism) by restoring function and structure.

Diagnostic

No

This device is an implant system used for supporting dental restorations in patients with missing teeth, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as implants, abutments, healing components, and screws, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes a surgical implant system for supporting dental restorations in the upper and lower jaws. This is a medical device intended for direct use in the human body for structural support.
Device Description: The description details the physical components of the implant system (implants, abutments, screws, etc.) and their design features.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.

The device described is a dental implant system, which is a type of medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DZE, NHA

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).

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaws, mandible, maxilla

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Clinical Performance Testing:
No clinical testing was performed. The clinical evaluation was used to support this decision.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102436, K071370, K090234, K081101, K081396, K061319, K092035, K073368, K030007

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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).

1

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:

2

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.

3

Implant Direct
Sybron Dental Speciality

nterActive/SwishPlus2 Implant System

Traditional 510(K) Submission

| Specific
Feature | InterActive and
SwishPlus2 | Predicate Device NobelActive 3.0
(K102436) & NobelActive NP/RP
(K071370) | Predicate Device:
Legacy+ (K090234) | Predicate Device:
SwissPlant
(K081396) | Predicate Device:
Bicon Implants
(K073368 and
K092035) | Predicate Device:
Straumann
(K030007) | Substantial
Equivalence |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 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): Indicated for
single-tooth replacement of
mandibular central and
lateral incisors and maxillary
lateral incisors. Also
indicated for multiple tooth
replacements or denture
stabilization. | Nobel Biocare's NobelActive implants
are endosseous implants intended to
be surgically placed in the bone of the
upper or lower jaw arches to provide
support for prosthetic devices, such as
an artificial tooth, in order to restore
patient esthetics and chewing function.
Nobel Biocare's NobelActive implants
are indicated for single or multiple unit
restorations in splinted or non-splinted
applications. Nobel Biocare's
NobelActive implants may be placed
immediately and put into immediate
function provided that initial stability
requirements detailed in the manual
are satisfied.

The NobelActive.3.0mm Implant Is
Indicated for use In the treatment of
missing maxillary lateral incisors or the
mandibular central and lateral incisors
to support prosthetic devices, such as
artificial teeth, In order to restore
chewing function in partially
edentulous patients. The NobelActive
3.0 implants may be put into
immediate function provided that
stability requirements detailed in the
manual are satisfied | Spectra-System Dental
Implants 2008 are
comprised of dental
implant fixtures and
prosthetic devices that
compose a two-piece
implant system. The
implants are intended for
use in the mandible and
maxilla, in support of
single unit or multiple
unit cement or screw-
receiving restorations
and for the retention and
support of overdentures.

The implants are
intended for immediate
placement and function
for the support of
singletooth or multiple-
tooth restorations,
recognizing bone
stability and appropriate
occusal load
requirements. | The SwissPlant
Dental Implant
system consists of
two-piece implants
for one or two-stage
surgical procedures
that are intended for
use in partially or fully
edentulous
mandibles and
maxillae, in support
of single or multiple-
unit restorations
including: cement
retained, screw
retained or
overdenture
restorations and in
terminal or immediate
abutment support for
fixed bridgework. The
SwissPlant dental
implants are intended
for immediate
placement and
function on single
tooth and/or | The 5.0 x 5.0mm
and the 6.0 x
5.0mm implants
are designed as a
one stage or two
stage surgical
procedure implant
for use in
edentulous sites in
the mandible or
maxilla for support
of a complete
denture prosthesis,
a terminal or
intermediate
abutment for fixed
bridgework, partial
dentures, or a
single tooth
replacement. | The ITI dental
implants are
intended for
immediate
placement and
function on single-
tooth and/or
multiple tooth
applications when
good primary
stability is achieved
and with
appropriate
occlusal loading, to
restore chewing
function. Multiple
tooth applications
may be rigidly
splinted. In the
case of edentulous
patients 4 or more
implants must be
used. | ✓ |

4

nterActive/SwishPlus2 Implant System

・・・・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Implant Direct
sybron Dental Specialis

."

SwissPlus2 Implant System

Traditional 510(K) Submission
InterActive/SwishPlus2 Dental Implants
Specific
Feature	InterActive and
SwishPlus2	1.	Indications for Use (Cont'd)	Substantial
Equivalence
		Predicate Device NobelActive 3.0
(K102436) & NobelActive NP/RP
(K071370)
		Predicate Device:
Legacy+ (K090234)	multiple tooth
applications
recognizing initial
implant stability and
appropriate occlusal
loading, to restore
normal masticatory
function.
		Predicate Device:
SwissPlant
(K081396)
		Predicate Device:
Bicon Implants
(K073368 and
K092035)	The Bicon implant
is designed for use
in edentulous sites
in the mandible or
maxilla for support
of a complete
denture prosthesis,
a final or
intermediate
abutment for fixed
bridgework or for
partial dentures, or
as a single tooth
replacement.
		Predicate Device:
Straumann
(K030007)		may be rigidly
splinted. In case of
edentulous patients
4 or more implants
must be used.
Specific
Feature	Indication	General
Design	Placement
Method	Material	Substantial
Equivalence
I. InterActive/SwishPlus2 Dental Implants
InterActive and
SwishPlus2	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 and
K092035)	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	√

5

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

6

Implant Direct.
Sybron Dental Speciality

nterActive/SwishPlus2 Implant System 1

"ve/Swish Plus2 Implant System

Traditional 510(K) Submission

| Specific
Feature | Implant Body Diameters and lengths | Interface
Name | | | Implant/
Abutment Interface | Engaging
Feature | Substantial
Equivalence |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----|--------------------------------------------------------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| InterActive and
SwishPlus2 | InterActive:
3.2mm Dia. X 8-16mm L
3.7mm Dia, X 6-
16mm L
4.3mm Dia. X 6-
16mm L
5.0mm Dia. X 6-
16mm L
SwishPlus2:
3.3mm Dia. X 8-
16mm L
4.1mm Dia. X 6-
16mm L
4.8mm Dia. X 6-
16mm L
5.7mm Dia. X 6-
16mm L | 3.0 Platform, 3.4mm Platform | i. | InterActive/SwishPlus2 Dental Implants | | | |
| I. InterActive/SwishPlus2 Dental Implants | | | | InterActive and
SwishPlus2 | 3.0mm and 3.4mm | Single 2.3 hex with M1.6
threads,
Single 2.7mm hex with M2
threads | |
| Predicate Device NobelActive 3.0
(K102436) & NobelActive NP/RP
(K071370) | 3.0mm Dia. X 10-15mm L
3.5mm Dia.X 8.5-18mm L
4.3mm Dia.X 8.5-18mm L
5.0mm 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
i

| P |

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
Feature | InterActive and
SwishPlus2 | Predicate Device NobelActive 3.0
(K102436) & NobelActive NP/RP
(K071370) | Predicate Device:
Legacy+ (K090234) | Predicate Device:
SwissPlant
(K081396) | Predicate Device:
Bicon Implants
(K073368 and
K092035) | Predicate Device:
Straumann
(K030007) | Substantial
Equivalence |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|----------------------------|
| Surface Treatment | SBM : Soluable Blasted
Media surface with
roughness between 1.5 μm
and 2.3 μm
or
HA: Soluable Blasted Media
surface with roughness
between 1.5 μm and 2.3 μm
at 3.5mm coronal section and
HA coated surface with
thickness of 5-15 microns on
the rest of the body length | TiUnite: Nobel Biocare's proprietary
titanium oxide dental implant surface | SBM : Soluable Blasted
Media surface with
roughness between 1.5
μm and 2.3 μm
or
HA: Soluable Blasted
Media surface with
roughness between 1.5
μm and 2.3 μm at 3mm
coronal section and HA
coated surface with
thickness of 35-60
microns on the rest of
the body length | SBM: Dual Soluable
Blasted Media
surface with
roughness between
0.3 μm and 0.9 μm in
the collar section and
1.5 μm and 2.3 μm in
the body section | Integra-Ti and
Integra-CP | SLA and SLActive | ✓ |

9

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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| | | |
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| | | |

| Specific
Feature | | Predicate Device:
Legacy+ (K090234) | Predicate Device:
SwissPlant (K081396) | Predicate Device:
Bicon Implants
(K073368 and K092035) | Predicate Device:
Straumann (K030007) | Substantial
Equivalence |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------|------------------------------------------|----------------------------|
| | I.
InterActive/SwishPlus2 Dental Implants | | | | | |
| InterActive and
SwishPlus2 | Predicate Device NobelActive 3.0
(K102436) & NobelActive NP/RP
(K071370) | N/A | N/A | N/A | N/A | √ |
| Compatibility with Abutments | 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 | Nobel Biocare conical connection
NobelActive™ NP (Narrow Platform –
3.0mm diameter) and NobelActive™
RP (Regular Platform – 3.4mm
diameter) abutments | N/A | N/A | N/A | |

10

、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 Cement
Retained Angled
Abutments	Predicate Devices:
36668, 36673
(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 2.7 mm hex
engaging feature with a
15 degree post and a
prosthetic margin	2.3 or 2.7mm hex engaging
feature with a 15 degree
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:
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	InterActive
Screw-Receiving
Overdenture Abutments	Predicate Devices:
P/N 36611, 36616
(K071370)	Substantial
Equivalence
Intended Use	To be used as a
transmucosal extension for
the fabrication of screw-
retained multiple-unit
prosthesis	To be used as a
transmucosal extension for
the fabrication of screw-
retained multiple-unit
prosthesis	√
General Design	Screw-in abutment that
does not engage the
internal hex connection of
the implant	Screw-in abutment that
does not engage the
internal hex connection of
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
Screw-Receiving
Overdenture Angled
Abutments with optional
Ball Tops	Predicate Devices:
P/N 6035-65-30
(K081101)	Substantial
Equivalence
Intended Use	To be used as a
transmucosal extension for
the fabrication of screw-
retained multiple-unit
prosthesis	To be used as a
transmucosal extension for
the fabrication of screw-
retained multiple-unit
prosthesis	√
General Design	Implant engaging feature
with a 30 degree angled
base and a threaded top to
received the overdenture
prosthetics	Implant engaging feature
with 30 degree angled
base and a threaded top to
received the overdenture
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
Gold Engaging
Abutments	Predicate Devices:
P/N 36728, 36729
(K071370)	Substantial
Equivalence
Intended Use	To be used as a castable	To be used as a castable

T

.

12

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
multiple restorations	abutment for single or
multiple restorations	√
General Design	Gold cylinder with hex
engaging feature and
castable plastic sheath	Gold cylinder with hex
engaging feature and
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
Gold None-Engaging
Abutments	Predicate Devices:
P/N 36726, 36727
(K071370)	Substantial
Equivalence
Intended Use	To be used as a castable
abutment for single or
multiple restorations	To be used as a castable
abutment for single or
multiple restorations	√
General Design	Gold cylinder with castable
plastic sheath	Gold cylinder with castable
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
Ball Abutments	Predicate Device:
8530-71
(K090234)	Substantial
Equivalence
Intended Use	To be used for cap
attachment overdenture
applications	To be used for cap
attachment overdenture
applications	√
General Design	Ball receiving cap
attachment systems with
thread engaging feature	Ball receiving cap
attachment systems with
thread engaging feature	√
Material	Titanium alloy	Titanium alloy	√

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . IX. Straight Full Contour Abutments

Implant/abut Interface

| Technological Characteristics | InterActive
Straight Full Contour
Abutments | Predicate Devices:
P/N 8530-30L
(K090234) | 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, 2.7mm hex engaging
feature with a straight post | 2.0mm hex engaging
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
Temporary Plastic
Abutments | Predicate Devices:
P/N 8530-47
(K090234) | Substantial
Equivalence |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | To be used as a temporary
post to support the
provisional prostheses for
single or multiple
restorations | To be used as a temporary
post to support the
cemented prostheses for
single or multiple
restorations | √ |
| General Design | 2.3-2.7mm hex engaging
feature with a straight post | 2.0mm hex engaging
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
Temporary Titanium
Abutments | Predicate Devices:
P/N 36661 and 36662
(K071370) | Substantial
Equivalence |
|-------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | To be used as a temporary
post to support the
provisional prostheses for
multiple restorations | To be used as a temporary
post to support the
provisional prostheses for
multiple restorations | √ |
| General Design | 3.0 - 3.4 non-engaging
interface with a straight
post | 3.0 - 3.4 non-engaging
interface with a straight
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.

14

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.

16

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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