(310 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of dental implants, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to restore chewing function and provide support for prosthetic devices, which are therapeutic interventions for patients with missing teeth.
No
The device is described as a dental implant intended for surgical placement to support crowns, bridges, or overdentures, restoring chewing function. Its purpose is mechanical support, not diagnosis.
No
The device description clearly states it is a physical dental implant made of Titanium 6AL-4V-ELI Alloy, which is a hardware component.
Based on the provided information, 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 Adin Dental Implants are surgically placed in the jawbone to support prosthetic devices and restore chewing function. This is a physical implant used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Adin Dental Implant is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.
Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows:
The TouaregTM-S and SwellTM short implants with internal hexagon in 6.25mm length are available in diameters of 4.20mm, 5.0 mm and 6.0mm. The implants surface treatment is AB/AE (Alumina Oxide Blast/Acid Etched) for both of them. The Touareg-S short implant has a spiral tapered design and the SwellTM short implant has a straight, parallel walled, slightly tapered V-shape thread design.
The Touareg-OS short implant with internal hexagon in 6.25mm length is available in diameters of 4.20mm, 5.0mm and 6.0mm. The implants surface treatment is OsseoFixTM (Calcium Phosphate). The TouaregTM-OS short implant has the same design as the Touareg 10-S. The only difference between them is the surface treatment.
As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch (upper or lower jaw)
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)
A series of safety and performance tests and evaluations were performed to demonstrate that Adin Short Implants do not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations included:
a) Pull-Out Testing: The test was performed to determining the axial pull-out strength of the Adin Short Implants as compared to the proposed predicate devices: MIS short implants (K103089) for the TouaregTM-S and OS short implants and Blue Sky Bio Dental Implant System (K102034) for the SwellTM short implant. The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device.
b) Comparative Bone to Implant Contact Surface Area Analysis: Contact surface area was analyzed in comparison to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation.
c) Comparative Surface Analysis Before Surface Treatment: Implant actual surface area before surface treatment was compared to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation.
d) Biocompatibility: Biocompatibility tests were conducted in accordance with FDA Guidance for Use of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, September 4, 2020, and; ISO 10993-1 for biological evaluation and: ISO 7405:2018 for evaluation of medical devices used in dentistry. In-vitro Cytotoxicity test of each surface treatment type, using the ISO Elution Method was conducted as well as Pyrogenic Material-Mediated and chemical extractions. ISO 10993-5. ISO 10993-11 and ISO 10993-18 were used for the Cytotoxicity, Pyrogen Material-Mediated and chemical extractions, respectively. Tests have been conducted using representative final implants with both surface treatments which went through Adin's entire production process, including packaging and sterilization (Gamma irradiation).
e) Surface Analysis After Surface Treatment: The implants' surface after surface treatments was tested for each surface treatment type (AB/EA and OsseoFixTM) using the SEM/EDS (Scanning Electron Microscope / Energy Dispersive X-ray Spectroscopy) which are valid, conventional and known methods to evaluate the quality of the treated surface area.
f) Gamma sterilization validation: Sterilization validation was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 for Sterilization of health care products Radiation - Part 2: Establishing the sterilization dose in conjunction with ISO/TS 13004, in order to assure SAL (Sterility Assurance Level) of 10-6. The sterilization validation includes both the implants and the cover screw.
g) Shelf-life validation: Shelf-life validation was performed in accordance with ISO 11607-1 for Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems standard. This validation confirmed that the sterility of Adin's sterile products will remain throughout the device shelf life.
h) MR Environment Condition: Non-clinical worst-case MRI review was performed to evaluate the metallic Adin Short Implants in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices", Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
All performance tests’ results and worst-case MRI review, support Adin’s labeling claims in order to establish substantial equivalency with the selected predicate devices.
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Adin Dental Implants Systems Ltd. % Tali Hazan RA Consultant Talmed Ltd Ramot-Naftali, M.P. Upper Galilee 1383000 ISRAEL
Re: K212775
Trade/Device Name: Adin Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 4, 2022 Received: June 9, 2022
Dear Tali Hazan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212775
Device Name Adin Short Implants
Indications for Use (Describe)
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use (R1-SFR, R1-Duplex) |
|---|
| On-Site Composting (R1-SFR only) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY FOR ADIN SHORT IMPLANTS K212775
DATE PREPARED: JULY 07, 2022
1. 510(K) OWNER NAME
Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone P.O. Box 1128, Afula 1811101, Israel Phone: +972-4-642-6732, Fax: +972-4-642-6732 Email: ilana.lutvak@adin-implants.com
Contact person name: Tali Hazan, RA Consultant, Talmed Ltd. Phone: +972-50-5292304, Fax: +972-72-2448981, Email: tali.hazan@talmed.co.il.
2. DEVICE NAME
- 2.1 Device's Trade name: Adin Short Implants
- 2.2 Classification Name: Implant, Dental, Endosseous, Root-Form
- 2.3 Device's Common Name: Endosseous dental implant
- 2.4 Regulation Number: 21 CFR 872.3640
- 2.5 Class: II
- 2.6 Product Code: DZE
3. PREDICATE DEVICES
Adin Short Implants are substantially equivalent to the following Predicate Devices:
- 3.1 Primary predicate device: Adin's Dental Implants System, cleared under 510(k) number K081751 on December 19, 2008.
- 3.2 Reference device: Adin's Touareg CloseFit™ Dental Implant System, cleared under 510(k) number K112585 on May 24, 2012.
- 3.3 Reference device: MIS's Short Implants, cleared under 510(k) number K103089 on September 15, 2011.
- 3.4 Reference device: Blue Sky Bio's Dental Implant System, cleared under 510(k) number K102034 on April 19, 2011.
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Image /page/4/Picture/0 description: The image contains four icons inside of circles. The first icon is a purple hexagon. The second icon is a blue triangle pointing downwards. The third icon is a green six-pointed star. The fourth icon is a gray symbol that looks like the letters VA.
4. DEVICE DESCRIPTION
Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.
Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows:
The Touareg™-S and Swell™ short implants with internal hexagon in 6.25mm length are available in diameters of 4.20mm, 5.0 mm and 6.0mm. The implants surface treatment is AB/AE (Alumina Oxide Blast/Acid Etched) for both of them. The Touareg-S short implant has a spiral tapered design and the Swell™ short implant has a straight, parallel walled, slightly tapered V-shape thread design.
The Touareg-OS short implant with internal hexagon in 6.25mm length is available in diameters of 4.20mm, 5.0mm and 6.0mm. The implants surface treatment is OsseoFix™ (Calcium Phosphate). The Touareg™-OS short implant has the same design as the Touareg 10-S. The only difference between them is the surface treatment.
As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Body contact materials were evaluated for biocompatibility in accordance with FDA's Guidance document for Use of ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, dated September 4, 2020 together with ISO 10993-1:2018 and ISO 7405:2018 standards.
5. INTENDED USE
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
5
Image /page/5/Figure/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle with a line above it inside of a circle. The third icon is a green six-pointed star inside of a circle. The fourth icon is a gray symbol inside of a circle.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Adin Short Implants have the same intended use as the MIS short implants that were cleared under 510(k) K103089, Adin's Touareg™-S and Swell™ implants cleared under 510(k) number K081751, Adin's Touareg CloseFit™ K112585 and Blue Sky Bio's Dental Implant System cleared under 510(k) number K102034 (excluding the one-piece implant model).
Adin Short Implants are available in three models: Touareg™-S, Touareg™-OS and Swell™. Two types of surface treatments are utilized for the short implants: AB/AE (Alumina Oxide Blast/Acid Etched), also used for Touareg™-S and Swell™ cleared implants and; OsseoFix™ (Calcium Phosphate), as cleared under 510(k) K112585, for Adin's Touareg CloseFit™ Dental Implant System.
For the purpose of substantial equivalency, the Touareg™-S, Touareg™-OS and Swell™ short implants are supported by Adin's 510(k) K081751 while the Touareg™-OS is further supported by 510(k) K112585 only to cover the OsseoFix™ surface treatment method. The MIS short implants cleared under K103089 support the 6.25mm length dimension of all Adin Short Implants' models. The Blue Sky Bio Dental Implant System cleared under 510(k) K102034, was used for additional support of Adin's Swell™ pullout force.
The subject device and its predicate devices have the same technology and basic performance characteristics. Except for the length dimensions, the design of the subject Touareg-STM and Swell™ short implants are exactly the same as the cleared Touareg-STM and Swell™ implants. The subject and predicate devices are manufactured from the same biocompatible Titanium alloy and undergo same machining, surface treatment and sterilization processes.
It was therefore concluded that Adin Short Implants are substantially equivalent to the predicate devices.
NON-CLINICAL PERFORMANCE DATA 7.
A series of safety and performance tests and evaluations were performed to demonstrate that Adin Short Implants do not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations included:
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Image /page/6/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a blue triangle with a line above it inside of a circle. The third icon is a green six-pointed star inside of a circle. The fourth icon is a gray symbol that looks like two letter V's inside of a circle.
a) Pull-Out Testing
The test was performed to determining the axial pull-out strength of the Adin Short Implants as compared to the proposed predicate devices: MIS short implants (K103089) for the Touareg™-S and OS short implants and Blue Sky Bio Dental Implant System (K102034) for the Swell™ short implant. The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device.
b) Comparative Bone to Implant Contact Surface Area Analysis-
Contact surface area was analyzed in comparison to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation.
c) Comparative Surface Analysis Before Surface Treatment -
Implant actual surface area before surface treatment was compared to both legally marketed devices (MIS short implants and Blue Sky Bio Dental Implant System, cleared under 510(k) K103089 and K102034, respectively), at worst case implant variation.
d) Biocompatibility -
Biocompatibility tests were conducted in accordance with FDA Guidance for Use of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, September 4, 2020, and; ISO 10993-1 for biological evaluation and: ISO 7405:2018 for evaluation of medical devices used in dentistry. In-vitro Cytotoxicity test of each surface treatment type, using the ISO Elution Method was conducted as well as Pyrogenic Material-Mediated and chemical extractions.
ISO 10993-5. ISO 10993-11 and ISO 10993-18 were used for the Cytotoxicity, Pyrogen Material-Mediated and chemical extractions, respectively. Tests have been conducted using representative final implants with both surface treatments which went through Adin's entire production process, including packaging and sterilization (Gamma irradiation).
e) Surface Analysis After Surface Treatment -
The implants' surface after surface treatments was tested for each surface treatment type (AB/EA and OsseoFix™) using the SEM/EDS (Scanning Electron Microscope / Energy Dispersive X-ray Spectroscopy) which are valid, conventional and known methods to evaluate the quality of the treated surface area.
7
Image /page/7/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle with a line above it inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is a gray VA inside of a circle.
Gamma sterilization validation f)
Sterilization validation was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 for Sterilization of health care products Radiation - Part 2: Establishing the sterilization dose in conjunction with ISO/TS 13004, in order to assure SAL (Sterility Assurance Level) of 10-6. The sterilization validation includes both the implants and the cover screw.
g) Shelf-life validation -
Shelf-life validation was performed in accordance with ISO 11607-1 for Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems standard.
This validation confirmed that the sterility of Adin's sterile products will remain throughout the device shelf life.
h) MR Environment Condition -
Non-clinical worst-case MRI review was performed to evaluate the metallic Adin Short Implants in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices", Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
All performance tests' results and worst-case MRI review, support Adin's labeling claims in order to establish substantial equivalency with the selected predicate devices.
8. SUBSTANTIAL EQUIVALENCE
Adin Short Implants are substantial equivalent to the predicate devices selected in terms of indication for use, technology, performances, design, place of use, patient population and nature of body contact.
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Image /page/8/Picture/0 description: The image contains four different symbols inside circles. The first symbol is a purple hexagon. The second symbol is a teal triangle pointing downwards. The third symbol is a green six-pointed star. The fourth symbol is a gray abstract symbol.
The Substantial equivalent decision was received based on the following comparison with the predicate devices:
| Feature | Adin Short
Implants
(Touareg-STM,
TouaregTM-OS,
SwellTM) | Adin's Touareg-S
and SwellTM
Dental Implants,
cleared under
K081751 | Adin's
CloseFitTM
Dental Implant
System, cleared
under K112585 | MIS'S MIS
Short
Implants,
cleared under
K103089 | Blue Sky Bio's
Dental Implant
System, cleared
under K102034 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Subject Device - | - Primary
Predicate Device - | - Reference
Device - | - Reference
Device - | - Reference
Device - |
| 510(k) number | K212775 | K081751 | K112585 | K103089 | K102034 |
| Classification | Class: II
Product code:
DZE
Regulation No.:
872.3640 | Class: II
Product code:
DZE (primary)
NHA (secondary)
Regulation No.:
872.3640 | Class: II
Product code:
DZE
(primary),
NHA
(secondary)
Regulation
No.: 872.3640 | Class: II
Product code:
DZE
(primary),
NHA
(secondary)
Regulation
No.: 872.3640 | Class: II
Product code:
DZE (primary),
NHA
(secondary)
Regulation No.:
872.3640 |
| Indications For
Use | Adin Dental
Implants are
intended for
surgical
placement in the
maxillary and/or
mandibular arch
to support crowns,
bridges, or
overdentures in
fully or partially
edentulous
patients in order
to restore a
patient's chewing
function. Adin
Dental Implants
may be
immediately
loaded when good
primary stability
is achieved and
with appropriate
occlusal loading.
Adin short
implants are to be
used only with
straight
abutments. | Adin 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.
Adin Dental
Implants may be
immediately
loaded when good
primary stability is
achieved and with
appropriate
occlusal loading. | Touareg
CloseFitTM
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.
Touareg
CloseFitTM
Dental
Implants may
be
immediately
loaded when
good primary
stability is
achieved and | MIS dental
implants are
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.
When a one
stage surgical
procedure is
applied, the
implant may be
immediately
loaded when
good primary
stability is
achieved and
the occlusal | Intended Use for
Two-Piece
Implant
Systems:
• For
implantation
into any area of
the fully
edentulous
maxilla and
mandible for
the support of a
removable or
fixed dental
prosthesis
• For single
tooth or
multiple unit
prosthesis
• For single
stage or two
stage surgical
procedure
• For immediate
placement and
immediate
function when
multiple units
are splinted |
| Feature | Adin Short
Implants
(Touareg-STM,
TouaregTM-OS,
SwellTM)
- Subject Device - | Adin's Touareg-S
and SwellTM
Dental Implants,
cleared under
K081751 - Primary
Predicate Device - | Adin's
CloseFitTM
Dental Implant
System, cleared
under K112585 - Reference
Device -
with
appropriate
occlusal
loading. | MIS'S MIS
Short
Implants,
cleared under
K103089 - Reference
Device -
load is
appropriate.
MIS short
implants are to
be used only
with straight
abutments. | Blue Sky Bio's
Dental Implant
System, cleared
under K102034 - Reference
Device -
and for single
units when
adequate initial
stability is
achieved in
type I or type II
bone and under
appropriate
occlusal
loading.
Multiple units
may be
splinted with a
bar. In
edentulous
cases restored
with a fixed
prosthesis, four
or more
implants must
be used. |
| Patient
population | Edentulous or
partially
edentulous
patients | Edentulous or
partially
edentulous patients | Edentulous or
partially
edentulous
patients | Edentulous or
partially
edentulous
patients | Edentulous or
partially
edentulous
patients |
| Sterility | Sterile using
Gamma
Irradiation | Sterile using
Gamma Irradiation | Sterile using
Gamma
Irradiation | Sterile using
Gamma
Irradiation | Sterile using
Gamma
Irradiation |
| Nature of body
contact | Implant in
bone/tissue
contact for long
term duration
(>30 d) | Implant in
bone/tissue contact
for long term
duration (>30 d) | Implant in
bone/tissue
contact for long
term duration
(>30 d) | Implant in
bone/tissue
contact for long
term duration
(>30 d) | Implant in
bone/tissue
contact for long
term duration
(>30 d) |
| Prescription or
Over-the-
Counter (OTC) | Prescription | Prescription | Prescription | Prescription | Prescription |
| Single use | Yes | Yes | Yes | Yes | Yes |
| Operation
Principle | Single or Two-
Stages procedure
(immediate or
delayed loading) | Single or Two-
Stages procedure
(immediate or
delayed loading) | Single or Two-
Stages
procedure
(immediate or | Single or Two-
Stages
procedure
(immediate or | Single or Two-
Stages
procedure |
| Feature | Adin Short
Implants
(Touareg-STM,
TouaregTM-OS,
SwellTM) - Subject Device - | Adin's Touareg-S
and SwellTM
Dental Implants,
cleared under
K081751 - Primary Predicate Device - | Adin's
CloseFitTM
Dental Implant
System, cleared
under K112585 - Reference Device - | MIS'S MIS
Short
Implants,
cleared under
K103089 - Reference Device - | Blue Sky Bio's
Dental Implant
System, cleared
under K102034 - Reference Device - |
| Placement
Method | Placing the
implant in the jaw
bone immediately
after drilling | Placing the implant
in the jaw bone
immediately after
drilling | Placing the
implant in the
jaw bone
immediately
after drilling | Placing the
implant in the
jaw bone
immediately
after drilling | Placing the
implant in the
jaw bone
immediately
after drilling |
| Self-Tapping | Yes | Yes | Yes | Yes | Yes |
| Implant
Material | Titanium Alloy -
6Al-4V-ELI | Titanium Alloy -
6Al-4V-ELI | Titanium
Alloy -
6Al-4V-ELI | Titanium Alloy - 6A1-4V-ELI | Titanium Alloy
- 6Al-4V |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Biocompatible |
| Shape | Screw type | Screw type | Screw type | Screw type | Screw type |
| Connection | Internal hexagon | Internal hexagon | Conical
hexagon | Internal
hexagon | Internal hexagon
with taper,
Internal Square
with taper (anti-
rotational
feature) |
| Surface
Treatment | AB/AE and
OsseoFixTM | AB/AE | OsseoFixTM
Calcium
Phosphate | Sand blasting
& Acid
Etching | Blasted with
resorbable
medium or
Aluminum
Oxide and Acid
Etched |
| Implanted
Length | 6.25 mm | 8, 10, 11.5, 13, 16,
18 mm | 8, 10, 11.5, 13,
16, 18 mm | 6.0 mm | 6-16 mm |
| Outer Diameter
(OD) | 4.2, 5, 6 mm | Swell Implant
Model: 3.30, 3.75,
4.2, 5, 6mm
Touareg-S Model:
3.5, 3.75, 4.2, 5,
6mm | 3.5, 3.75, 4.2,
5, 6mm | 4.2, 5, 6 mm | 3.25-5.0 mm |
| Abutment
Angulation | Straight abutment
only | Straight and up to
25° | Straight and up
to 25° | Straight
abutment only | Straight and up
to 30° |
| Packaging
(Microbial
Barrier) | Sterile barrier
Protective Tube | Sterile barrier
Protective Tube | Sterile barrier
Protective
Tube | Sterile barrier
Protective
Tube | Sterile barrier |
| Feature | Adin Short
Implants
(Touareg-STM,
TouaregTM-OS,
SwellTM) | Adin's Touareg-S
and SwellTM
Dental Implants,
cleared under
K081751 | Adin's
CloseFitTM
Dental Implant
System, cleared
under K112585 | MIS's MIS
Short
Implants,
cleared under
K103089 | Blue Sky Bio's
Dental Implant
System, cleared
under K102034 |
| | - Subject Device - | - Primary
Predicate Device - | - Reference
Device - | - Reference
Device - | - Reference
Device - |
| Shelf-Life | 5 years | 5 years | 5 years | Information
not available | Information not
available |
July 07, 2022
9
Image /page/9/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow-green star inside of a circle. The fourth icon is a gray VA inside of a circle.
July 07, 2022
10
Image /page/10/Picture/0 description: The image contains four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow-green six-pointed star inside of a circle. The fourth icon is the letters VA in gray inside of a circle.
July 07, 2022
11
Image /page/11/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow star inside of a circle. The fourth icon is a gray image of the letters VA inside of a circle.
Substantial Equivalence Discussion:
The proposed Adin Short Implants have same indications for use, technological characteristics, mode of operation and, performance specifications as the above identified predicate devices. The proposed device utilizes same intended use as the predicate devices and is placed using the same methodology as all selected predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw. Similarities and differences were addressed by Adin. It can be seen that certain differences presented in the comparison table, are all within the range of one or more predicate device(s).
For the purpose of the comparison with Adin Short Implants, several aspects were removed from the indications for use of the Blue Sky Bio dental implant System, since are referring to Blue Sky Bio's one-piece model, two-piece narrow implants, angled abutments, as well as device adjustments to other companies products. These features are not included in any of Adin's claims within this submission and therefore, these parts were removed from the indications for use column of the comparison table. Blue Sky Bio's implants served only for the purpose of comparing the pull-out force, surface area and bone-to-implant (BIC) measurements. It can be seen from the comparison table that this implant, like the other predicates, has the same or highly similar technological characteristics. It has a similar material, screw type shape, similar dimensions and internal hexagon connection. Some minor differences do not raise new questions of safety and effectiveness.
Therefore, it was concluded that Adin Short Implants and the predicate devices are substantially equivalent.
12
Image /page/12/Picture/0 description: The image shows four different icons. The first icon is a purple hexagon inside of a circle. The second icon is a teal triangle pointing downwards inside of a circle. The third icon is a yellow-green six-pointed star inside of a circle. The fourth icon is a gray image of the letters 'VA' inside of a circle.
9. CONCLUSIONS
Adin Short Implants, which are the subject of this 510(k) Submission, are substantially equivalent to the predicate devices cited above. The device has met its requirements and labeling claims per its intended use. The device does not introduce new risks and does not present any new adverse health effects or safety potential risks to patients when used as intended.
Therefore, it was concluded that the overall evaluation of our device performances demonstrates that it is as safe and as effective as the predicate devices and therefore substantially equivalent.