(191 days)
No
The summary describes a dental implant system with specific physical characteristics and materials, and mentions fatigue testing. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is a dental implant intended to replace missing teeth, which restores a physical function rather than providing a therapeutic effect like treating a disease or condition.
No
The device is a dental implant intended to replace missing teeth, not to identify or diagnose a medical condition.
No
The device description clearly details a physical dental implant made of Ti6AL4V ELI, along with associated hardware components like cover screws, healing abutments, and abutments. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a dental implant intended to replace missing teeth in the mandible or maxilla. It is a physical implant placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, the TOUAREG CloseFit™ UNP 2.75mmD dental implant is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.
The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.
All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment. The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.
The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.
The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or 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 Data
Fatigue test was performed according to ISO 14801:2007 on the TOUAREG CloseFit™ UNP 2.75mmD dental implants and showed equivalence to the predicate devices.
Clinical Performance Data
No clinical performance data is provided in this submission.
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.
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 stylized eagle or bird symbol, with three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Adin Dental Implants Systems Ltd. c/o Iman Khorshid CEO, Founder ORS Industrial Park Tefen Tefen 2495900 ISRAEL
Re: K153111
Trade/Device Name: TOUAREG CloseFit™ UNP 2.75mmD Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 31, 2016 Received: April 6, 2016
Dear Iman 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. 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina Kiang
-s
for 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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name TOUAREG CloseFit™ UNP 2.75mmD
Indications for Use (Describe)
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.
The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Image /page/3/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.
510(k) Summary:
TOUAREG CloseFit™ UNP 2.75mmD Implants
Company Name: Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone P.O.Box 1128, Afula Hazafon, 1811101 ISRAEL Telephone: + 972-4-6426732 Fax: +972-4- -6426733
Establishment Registration Number: 3007518363
| Contact Name: | Iman Khorshid – Regulatory Consultant
QRS |
|---------------|----------------------------------------------|
| | Mobile: +972-54-3023043 |
| | Telephone: + 972-4-6860006 |
| | Fax: +972-4-6860006 |
| | E-mail: iman@qrs-global.com |
US Agent: Markus Weitz Adin Implants USA 657 Central Ave Cedarhurst , NY 11516 Phone: 212 7642900 212 7642349 Fax: E-mail: info@adinimplants.com
Date prepared: May 5, 2016
Trade Name: TOUAREG CloseFit™ UNP 2.75mmD
Classification name: Endosseous Dental Implant
Common/usual name: Dental Implant
Product Code: DZE; NHA
Regulation No.: 872.3640
Class: II
Panel identification: Dental Devices Panel
510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 1 of 5
4
Image /page/4/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a blue circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.
Predicate Devices:
Primary Predicate: Adin Dental Implant Systems Ltd. dental implants Touareg CloseFit™ NP, cleared under 510(k) K140293.
Reference Predicates: Anthogyr SAS' Axiom 2.8 implant cleared under 510(k) K141450 and Adin Dental Implant Systems Ltd. dental implants Touareg CloseFit™, cleared under 510(k) K112585.
Description of the device:
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).
The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.
All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.
The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.
The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 2 of 5
5
Image /page/5/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 on the left, followed by the word "ADIN" in large, bold, dark blue letters. Below the word "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller font size. There is also a curved line above the word "ADIN".
Indications for Use:
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 thefunctional load is appropriate.
The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
Substantial Equivalence:
Technological Characteristics
The TOUAREG CloseFit™ UNP 2.75mmD implants have the same intended use as Adin Dental Implant Systems Ltd. TOUAREG NP CloseFit™ Dental Implants, cleared under 510(k) K140293 with the exception of the elimination of the specific indications for the TMA Abutment cleared in the primary predicate K140293 but is not included in the current submission device. Further the indications for the submission device are identical to the reference predicate K141450. The material used for the TOUAREG CloseFit™ UNP 2.75mmD dental implants and abutment (Ti6AL4V ELI), as well as the surface treatment and other manufacturing methods, are identical to Adin's TOUAREG NP CloseFit™ Dental Implants as well as previously cleared Adin's TOUAREG CloseFit™ Dental Implants, cleared under 510(k) K112585. The sterility status of the implant bodies and abutments are identical to Adin's previously cleared TOUAREG NP CloseFit Dental Implants and the previous sterilization validation supports the sterility of the current submission. The available abutment designs are similar to the applicant's own previously cleared dental abutments and the maximum angulation of the abutment is the same as the applicant's own predicate devices as well as supported for substantial equivalence by fatigue test results.
The main differences between the submission device and the primary predicate 510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 3 of 5
6
Image /page/6/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.
are the reduction in implant body diameter for the submission device from 3.0mm to 2.75mm and the inclusion of an 18mm length implant body. The reference predicate Axiom 2.8 Implant K141450 supports the reduction in implant body diameter. The reference predicate K112585 supports the inclusion of a longer implant body.
| | Touareg CloseFitTM
UNP Dental
Implants from Adin
Dental Implant
Systems Ltd. | Touareg NP
CloseFitTM Dental
Implants from Adin
Dental Implant
Systems Ltd. | Axiom® 2.8
Implants from
Anthogyr SAS | Touareg CloseFitTM
Dental Implants
from Adin Dental
Implant Systems
Ltd. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Predicate | | Primary Predicate | Reference Predicate | Reference Predicate |
| 510(k)
number | | K140293 | K141450 | K112585 |
| Product
Code | DZE | DZE | DZE | DZE |
| Indications
For Use | TOUAREG
CloseFitTM UNP
2.75mmD implants | Intended use for
Touareg NP
CloseFitTM Dental | ANTHOGYR
Axiom® implants
are intended for use | Touareg CloseFitTM
Dental Implants are
intended for |
| Touareg CloseFit™
UNP Dental
Implants from Adin
Dental Implant
Systems Ltd. | Touareg NP
CloseFit™ Dental
Implants from Adin
Dental Implant
Systems Ltd. | Axiom® 2.8
Implants from
Anthogyr SAS | Touareg CloseFit™
Dental Implants
from Adin Dental
Implant Systems
Ltd. | |
| are indicated 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 an
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
CloseFit™ UNP
2.75mmDDental
Implant shall only
be used to replace
maxillary lateral
incisors and
mandibular lateral
and central incisors. | 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 may be
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 | as artificial
root structures for
replacement of
missing teeth. They
can be
used for fixation of
single tooth
restorations.
ANTHOGYR
dental systems are
indicated for one-
stage or two stage
surgery. It is up to
the practitioner to
decide whether
immediate or
delayed loading is
most appropriate,
based on
clinical factors like
good primary
stability and
appropriate
occlusal loading.
Axiom® 2.8
implants are
indicated for single
replacement of
mandibular incisors
and lateral
maxillary incisors
in cases
presenting a
restricted
mesiodistal space.
The prosthetic
components of the
Axiom 2.8 product
line are
intended to ensure
support for single | surgical placement
in the maxillary
and/or mandibular
arch to support
crowns, bridges, or
overdentures in
edentulous or
partially edentulous
patients.
Touareg CloseFit™
Dental Implants
may be immediately
loaded when good
primary stability is
achieved and with
appropriate occlusal
loading. | |
| | Touareg CloseFitTM
UNP Dental
Implants from Adin
Dental Implant
Systems Ltd. | Touareg NP
CloseFitTM Dental
Implants from Adin
Dental Implant
Systems Ltd.
restorations, and
may be used in
combination with
an implant level
framework design. | Axiom® 2.8
Implants from
Anthogyr SAS
crowns only. | Touareg CloseFitTM
Dental Implants
from Adin Dental
Implant Systems
Ltd. |
| Supplied
Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of
Construction | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Surface
Treatment | OsseoFixTM and
anodized | OsseoFixTM and
anodized | BCP® | OsseoFixTM and
anodized |
| Length | 10, 11.5, 13, 16 and
18 mm | 10, 11.5, 13 and 16
mm | 10, 12, and 14 mm | 8, 10, 11.5, 13, 15
and 18 mm |
| Thread
Diameter | 2.75 mm | 3.0 mm | 2.8 mm | 3.5, 4.3 and 5.0 mm |
| Abutment | Straight and up to 15° | Straight and up to 15° | Straight and up to 23° | Straight and up to 15° |
| Material of
Construction
of
Abutments | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI | Titanium Alloy –
Ti6Al4V ELI |
7
Image /page/7/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle on the left side of the logo. To the right of the circle is the company name, "ADIN", in large, bold, blue letters, with the words "DENTAL IMPLANT SYSTEMS LTD" in smaller letters underneath.
8
Image /page/8/Picture/0 description: The image is the logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle on the left, followed by the text "ADIN" in bold, dark blue letters. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller font size.
Non-Clinical Performance Data
Fatigue test was performed according to ISO 14801:2007 on the TOUAREG
CloseFit™ UNP 2.75mmD dental implants and showed equivalence to the predicate devices.
Clinical Performance Data
No clinical performance data is provided in this submission.
Conclusion:
The evaluation of the TOUAREG CloseFit™ UNP 2.75mmD dental implants may therefore be considered substantially equivalent to its predicate device.