(268 days)
Not Found
No
The summary describes a physical dental implant system and its associated components, focusing on materials, dimensions, surgical procedures, and performance testing related to mechanical properties and sterilization. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is used to replace missing masticatory units (teeth), which restores a physiological function.
No
This device is a dental implant system used to replace missing teeth, acting as an artificial root structure, rather than diagnosing a condition.
No
The device description clearly states it consists of physical components like root form dental implants and associated abutment systems made from Ti-Al-V alloy, which are surgically implanted. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that is surgically implanted into the body to replace missing teeth. This is a therapeutic and structural function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a physical implant and associated components for surgical placement and prosthetic attachment. It does not mention any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples like blood, urine, tissue, etc., which are hallmarks of IVD devices. The device's function is entirely mechanical and biological integration within the patient's body.
Therefore, the Touareg NP CloseFit™ Dental Implant System is a medical device, but it falls under a different classification than IVD.
N/A
Intended Use / Indications for Use
Intended use for Touareg NP CloseFit™ Dental Implant System:
- To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
- For single-stage or two-stage procedures.
- For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
- The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
- The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.
Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touareg TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).
The system includes accessories :laboratory analogs, impression copings, drivers for implants insertion (Class l exempt, not a subject of this submission) intended to facilitate the preparation of prosthetic restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla (oral cavity)
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)
For a determination of substantial equivalence, the following analysis and bench performance test was performed on Subject Devices and Predicate Devices:
- Touareg NP CloseFit™ Dental Implant System was analyzed to identify worst-case test samples. These worst-case test samples (rational for choosing the Worst case is at Section 18) were subject to fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document" Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants". The test was done with angled abutments to demonstrate the design changes did not change the fatigue properties. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device. The testing represent that the implants and abutments are substantially equivalent to the identified predicates.
- Further. NP CloseFit™ Dental Implant System also underwent extensive validation activities for cleaning. packaging, shelf-life and sterilization in accordance with Guidance for industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and all applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 11137-1, Sterilization of health care products -- Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In addition, NP CloseFit™ Dental abutments also underwent extensive validation activities for moist heat sterilization for achieving a Sterility Assurance Level of 10 (according to the FDA consensus standards) by using the parameters: Moist-Heat Sterilization at gravity fed autoclave 132 C° For 15 minutes exposure time, 20 minutes drying time, using the Overkill method. The sterlization was made in accordance with applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 17665-1:2006 Sterilization of health care products - Moist heat -- Part 1: Requirement, validation and routine control of a sterilization process for medical devices and ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
- Results of risk analysis, case studies, sterilization validation, and packaging testing have demonstrated that Touareg NP CloseFit™ Dental Implant System equivalent to the predicate device implants tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31,2014
Adin Dental Implant Systems Limited Ms. Iman Khorshid VP Regulatory Affairs Industrial Zone Alon Tavor POB 1128 Afula Elit, 1811101 ISRAEL
Re: K140293
Trade/Device Name: Touareg NP CloseFit™ Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 16, 2014 Received: September 26, 2014
Dear Ms. Khorshid:
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.
1
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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside a blue circle, followed by the text "ADIN" in bold, dark blue letters. Below the text, the words "ADIN DENTAL IMPLANT SYSTEMS LTD" are written in a smaller font.
Section 010- Indication For Use Statement
An Indication for Use Statement for the Touareg NP CloseFit™ Dental Implants System is provided below.
510(k) Number (if known): K140293
Device Name:
Touareg NP CloseFit™ Dental Implants System
Indications for Use:
Intended use for Touareg NP CloseFit™ Dental Implant System:
- 0 To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
- For single-stage or two-stage procedures. O
- For immediate implantation in extraction sites or implantation in 0 partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
- . The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
- The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, ● screw-retained restorations, and may be used in combination with an implant level framework design.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
| Prescription Use | |
|---|---|
| ------------------ | -- |
Over-The-Counter Use
(21 CFR 801 Subpart D)
AND/OR
(21 CFR 801 Subpart C)
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Center for Devices and Radiological Health / CDRH
3
Image /page/3/Picture/1 description: The image shows the logo for ADIN Dental Implant Systems LTD. The logo features a blue circular graphic on the left, followed by the text "ADIN" in bold, dark blue letters. Below "ADIN" is the text "ADIN DENTAL IMPLANT SYSTEMS LTD" in a smaller font size. A curved line extends over the logo.
Section 003- 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92 And according with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
Submitter Information
ADIN DENTAL IMPLANT SYSTEMS LTD Industrial Zone Alon Tavor POB 1128 Afula Elit, 1811101, Israel Tel: (+972)-4-9116162, Cell :( +972)-548-070-138, Fax: (+972) 4-6426733 iman@adin-implants.com Establishment Reg. Number: 3007518363
Submission contact person:
Iman Khorshid VP Regulatory Affairs Tel: (+972)-4-9116162, Cell :( +972)-548-070-138, Fax: (+972) 4-6426733 iman@adin-implants.com
Date of Submission: 21-
January-2014 Device
Classification
| Trade/Proprietary Device Name: | Touareg NP CloseFit TM Dental Implant | Common | |||
|---|---|---|---|---|---|
| name: | Endosseous Dental Implant | 21 CFR 872.3640 | |||
| Product Code: | DZE (subsequent code NHA) | ||||
| Classification Name: | Endosseous Dental Implant | ||||
| Classification Regulation: | 21 CFR §872.3640 | ||||
| Classification Panel: | Dental Devices | ||||
| Regulatory Class: | II |
4
Image /page/4/Picture/1 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with a curved line extending from the top of the "A" to the right. The word "ADIN" is written in bold, dark blue letters to the right of the "A" symbol. Below "ADIN" is the text "Dental Implants Sys. LTD." in a smaller font size.
Identification of Primary Legally Marketed Predicate Devices
-
- ADIN Dental Implant Systems, Endosseous Dental Implant cleared under K081751, (product code DZE, Regulation No. 872.3640).
-
- Asstra Tech AB OsseoSpeed™ Narrow Endosseous Dental Implant cleared under K080396 (product code DZE, Regulation No. 872.3640).
Device Description and function
Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.
Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are
taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around
the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).
Flat connection abutments
Abutments with flat connection for screw retained restoration. Cement retained
abutments
These abutments are providing support to prosthetic restoration. The abutments are intended for cemented restorations. The abutment screw intends for securing the abutment to endosseous implant.
Healing Abutments
Healing abutments of specific diameters and shapes are fixated on the implants to displace the gingiva from the space above the implant during the Implant healing time and serve for proper gingiva shaping. They are available in diameters of 3.0 and 4.5mm.
Ball Attachment
Ball abutments are used for implant-retained mucosa-supported restorations, such as dentures.
The device is a prescription use, labeled "Rx only", the device is qualifies for exemption per 21 CFR 801 Subpart D.
5
Image /page/5/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with the letters "DIN" in bold, dark blue font to the right of the "A". Below the letters "ADIN" is the text "Dental Implants Sys. LTD." in a smaller, lighter font. The logo has a professional and modern look.
The system includes accessories :laboratory analogs, impression copings, drivers for implants insertion (Class l exempt, not a subject of this submission) intended to facilitate the preparation of prosthetic restorations.
Additional description of specific items
The submission contains drawings of abutments compatible with 3.0mm diameter implant.
- · The difference between the NP tapered cover screw (NP-0073) and the NP implant cover screw (NP-0002) is: NP-0002 is covering the outer diameter of the implant and NP-0073 is covering only the opening of the implant.
- · The use of the NP Flat Connection Abutments (NP-0030 NP-0031) is: these are transmucosal abutments for retaining screw restoration.
- · The use of the NP Locator Abutments 2-6mm (for example, NP-0052) is for "locator" attachment for Overdenture.
- The use of the NP-Angled Trans Mucosal Abutments (NP-0035 NP-0038) is for: Correct angulations of dental implants, it is for the multi-unit, screw retained restorations. Used to elevate seating platform of restoration when restoration to implant level not practical.
Intended use for Touareg NP (Narrow-Platform) CloseFit™ Dental Implant system
The implants and the TMA abutments are intended to be used to:
- . Replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
- For single-stage or two-stage procedures.
- For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations, when a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved, and the functional load is appropriate.
- The Touareg NP CloseFit™ Dental Implant shall only be used to replace Maxillary lateral incisors and mandibular lateral and central incisors.
- The Trans Mucosal Abutment System (TMA) is indicated for multiple-unit, screw-retained restorations, and ● may be used in combination with an implant level framework design.
Principle of Operation
Each Touareg NP CloseFit™ Dental Implant System has a unique design characteristic for matching implants. abutments and prosthetics once assembled.
When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. The Touareg NP CloseFit™ Dental Implant system shall only be used to replace maxillary lateral incisors and mandibular Lateral and central incisors.
Performance Standards
The performance standards which were utilized for demonstrating potential equivalence in this submission were: ISO 14801, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, ISO 11737-2, ISO 11138-1, ISO 11138-3, ISO 14644-1, ISO 14644-3, ISO 14644-4, ISO 14971,ISO 14161, ISO 10993-1, ASTM F136-12,ASTM F2338, AAMI ST79. AAMI TIR33. USP 71. USP 85. USP161. under Section 514 of the Federal Food. Drug, and Cosmetic Act.
6
Image /page/6/Picture/0 description: The image is a logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with a swoosh above the letters "ADIN". The text "Dental Implants Sys. LTD." is written in a smaller font below the letters "ADIN". The logo is simple and modern, and it is likely used to represent the company's brand.
Guidance
Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff
Comparison to the predicate device:
The Touareg NP CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System, K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg NP CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. In addition, its indications were extended (please see comparison table, in the Indication for use info).
| Characteristic | Subject Dental Implant System | Predicate Dental
Implant System | Predicate Dental
Implant System |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K080396 | K081751 |
| Manufacturer | Adin Dental Implant Systems | ASTRA TECH AB | Adin Dental
Implants System |
| Item | Touareg NP CloseFit™
Dental Implant and abutments | OsseoSpeed™
Narrow | Dental Implant
System |
| Indication for
use | •Replacement for missing
masticatory functional units
(teeth) in single or multiple
unit applications within the
mandible or maxilla.
•For single-stage or two-stage
procedures.
•For immediate implantation in
extraction sites or implantation
in partially healed or completely
healed alveolar ridge situations,
when a one-stage surgical
approach is applied, the implant
maybe immediately | •To replace missing
masticatory
functional units
(teeth) in single or
multiple unit
applications within
the mandible or
maxilla.
•The device may be
used equally well in a
single stage or
two-stage surgical
procedure.
•For immediate
implantation in | • Dental Implants
are intended for
surgical placement
in the maxillary
and/or mandibular
arch to support
crowns, bridges, or
overdentures in
edentulous or
partially
edentulous
patients.
• The Dental
Implants may be
immediately |
| Characteristic | Subject Dental Implant System | Predicate Dental Implant System | Predicate Dental Implant System |
| | loaded when good primary
stability is achieved, and the
functional load is appropriate.
The Touareg NP CloseFitTM Dental Implant shall only be
used to replace Maxillary lateral incisors and mandibular lateral
and central incisors. The Trans Mucosal Abutment System (TMA) is indicated for
multiple-unit, screw-retained restorations, and may be used in
combination with an implant level framework design. | extraction sites or
implantation in
partially healed or
completely healed
alveolar ridge
situations.
When a one-stage surgical approach is
applied, the implant may be immediately
loaded when good primary stability is
achieved and the functional load is
appropriate. The OsseoSpeed Narrow product line
shall be used only to replace maxillary
lateral incisors and mandibular lateral
and central incisors. | loaded when good
primary stability is
achieved and with
appropriate
occlusal loading |
| Performance
specification | The Implants were subjected to
fatigue testing. | The Implants were
subjected to analysis of
mechanical strength. | The Implants were
subjected to analysis
of mechanical
strength. |
| Summary of the
technological
characteristics | The implants are Surgically
implanted in partially healed or
completely healed alveolar ridge
situations When a one- stage
surgical approach is applied, the
implant may be immediately
loaded when | Immediate loading of
single tooth
restorations may not be
appropriate in such
situations. | The implants are
Surgically inserted
into the upper and/or
lower jawbone and
are left to heal
(osseointegrate) |
| Characteristic | Subject Dental Implant System | Predicate Dental Implant System | Predicate Dental Implant System |
| | good primary stability is achieved and the functional load is appropriate | | with the bone for a period of up to six months |
| Angulations of dental system | 17, 30 | Not known | 17 |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Diameter | 3.0mm | 3.0mm | |
| Manufacturing technology | Machining | Machining | Machining |
Comparison Table for Dental Implant System:
7
Image /page/7/Picture/0 description: The image is a logo for ADIN Dental Implants Sys. LTD. The logo features a blue circle with a white "A" inside of it. To the right of the circle is the word "ADIN" in large, bold, blue letters. Below the word "ADIN" is the phrase "Dental Implants Sys. LTD." in smaller, blue letters.
8
Image /page/8/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter A inside of a blue circle. The company name is written in bold, blue letters to the right of the circle.
Packaging/Labeling/Product
Advertising material to be used for promotion of the Touareg NP CloseFit™ Dental Implants will be consistent with the indications for use and other materials shown herein.
All materials, suppliers, processing, packaging methods remain the same as those utilized for the predicate (K081751). Touareg NP CloseFit™ Dental Implants are packaged in a radiation sterilizable package. Sterilization is accomplished by means of Co 60 gamma irradiation.
Sterilization is validated by the bioburden method. The sterility assurance level (SAL) that Adin Dental Implant Systems Ltd. intends to meet for the Touareg NP CloseFit™ Dental Implants is 10 °. The device is not represented to be "pyrogen-free".
Abutments and instruments will be packaged non-sterile in plastic bags.
Safety & Effectiveness
The intended use of the submitted Toureg NP CloseFit™ Dental Implant System is identical to the legally marked devices Adin Dental Implants System - K081751
Similarity of intended use and technological features demonstrated, therefore, the risks and benefits are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of modified Touareg NP CloseFit™ Dental Implants.
Substantial Equivalence Statement:
Adin Dental Implant Systems Ltd. demonstrated that, for the purposes of FDA's regulation of medical devices, the Touareg NP CloseFit™ Dental Implant system is substantially equivalent in indications, design and functional features to predicate devices.
Brief Discussion and conclusions drawn from the Non-Clinical Tests Submitted
For a determination of substantial equivalence, the following analysis and bench performance test was performed on Subject Devices and Predicate Devices:
9
Image /page/9/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" inside a blue circle on the left. To the right of the circle, the word "ADIN" is written in large, bold, blue letters. Below the word "ADIN", the words "Dental Implants Sys. LTD." are written in smaller letters.
- · Touareg NP CloseFit™ Dental Implant System was analyzed to identify worst-case test samples. These worst-case test samples (rational for choosing the Worst case is at Section 18) were subject to fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document" Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants". The test was done with angled abutments to demonstrate the design changes did not change the fatigue properties. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device. The testing represent that the implants and abutments are substantially equivalent to the identified predicates.
- · Further. NP CloseFit™ Dental Implant System also underwent extensive validation activities for cleaning. packaging, shelf-life and sterilization in accordance with Guidance for industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and all applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 11137-1, Sterilization of health care products -- Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In addition, NP CloseFit™ Dental
abutments also underwent extensive validation activities for moist heat sterilization for achieving a
Sterility Assurance Level of 10 (according to the FDA consensus standards) by using the parameters: Moist-Heat Sterilization at gravity fed autoclave 132 C° For 15 minutes exposure time, 20 minutes drying time, using the Overkill method. The sterlization was made in accordance with applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 17665-1:2006 Sterilization of health care products - Moist heat -- Part 1: Requirement, validation and routine control of a sterilization process for medical devices and ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
- · Results of risk analysis, case studies, sterilization validation, and packaging testing have demonstrated that Touareg NP CloseFit™ Dental Implant System equivalent to the predicate device implants tested.