(289 days)
No
The summary describes a mechanical device (an orthodontic mini implant) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: The device is a mini implant used as an anchorage point for orthodontic appliances. It facilitates the movement of teeth but does not directly treat a disease or condition itself. Its function is primarily mechanical support during orthodontic treatment.
No
The device is described as an orthodontic mini implant used as a fixed anchorage point for orthodontic appliances, which facilitates the movement of teeth. It serves as a physical support for treatment and there is no mention of it diagnosing any condition or disease.
No
The device description clearly states it is a "screw-shaped product" and mentions physical and mechanical fixing, indicating it is a hardware device. The performance studies also focus on mechanical properties and biocompatibility, which are relevant to a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The Bio-TackS Orthodontic Mini Implant is a physical device that is implanted into the jawbone to provide anchorage for orthodontic treatment. It is used in vivo (within the body) and does not involve testing samples from the body.
The description clearly indicates a surgical implant used for mechanical support, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Bio-TackS Orthodontic Mini Implant is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Product codes
OAT
Device Description
Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only - qualified dentists. Strictly reserved to specialized and trained users.
Use only by professional orthodontists
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
Non-clinical performance tests were performed according to the test standard, ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
The following tests for performance of the subject device have been conducted; Sterilization and Shelf Life, Insertion-Removal torque test, Rotational fracture torque strength test, and Axial pull-out strength testing.
Sterilization validation was performed according to ISO 11137-1. ISO 11137-2, and ISO 11137-3 using the VDmax25 method. Shelf life of the packaging was demonstrated by accelerated aging of the product with evaluations for seal peeling (ASTM F88), dye penetration (ASTM F1929), and sterility testing.
Insertion torque / removal torque testing was performed to evaluate the mechanical stability of orthodontic mini implants. The largest diameter (1.8mm) and longest (10mm) screws were tested as the worst case; BSH1810S (BioTackS), OSSH1810 (Osstem Mini Implant). Both samples demonstrated almost equivalent torque values when inserted and removed at 1440 degrees at 1 rpm.
Rotational fracture torque testing was performed to determine the material yield strength. The smallest diameter (1.4mm) with a 10mm length; BSH1408S (BioTacks), OSSH1408 (Osstem mini implant) were tested. Both implants are made from the same raw material (titanium alloy-ELI grade 23), so the material yield strengths of both products are the same. In addition, all screw-head types, with the same diameter and length, are tested.
Axial pull-out strength testing was performed for the effectiveness of the mechanical design of the orthodontic mini implant and its elimination. The screw samples with the shortest (6mm) and smallest diameter (1.4mm) were tested: BSH1406S (BioTackS). OSSH1406 (Osstem mini implant). The test data demonstrated similar results.
Bench Test included rotational fracture torque strength testing for all screw-head types, with the same diameter and length. The test results were similar. Differences of Head structure do not affect effectiveness or safety of the Bio-TackS Orthodontic Mini Implant and Predicate Device. The results of the bench testing demonstrate similar performance for Bio-TackS Orthodontic Mini Implant and the predicate device.
Biocompatibility testing accordance with ISO 10993-1 has been conducted for Bio-TackS Orthodontic Mini Implant. Tests included Cytotoxicity, Acute Systemic Toxicity, Intracutaneous (Intradermal) Reactivity, and Local Lymph Node Assay (LLNA). All results were favorable (Non-cytotoxic, Non-acute systemic toxicity, None Irritation, Do not show any hypersensitivity).
Clinical testing was not required to demonstrate the substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2020
BIO CETEC CO., LTD. % Dave Kim Medical Device Regulatory Affairs MTech Group Inc. 8310 Buffalo Speedway Houston, Texas 77025
Re: K190871
Trade/Device Name: Bio-TackS Orthodontic Mini Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: December 17, 2019 Received: December 17, 2019
Dear Dave Kim:
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 (OS) 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.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190871
Device Name Bio-TackS Orthodontic Mini Implant
Indications for Use (Describe)
The Bio-TackS Orthodontic Mini Implant is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K190871 510(k) Summary
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: January 17, 2020
1. 510K Applicant / Submitter:
BIO CETEC CO., LTD. RM 1001-1002 New T Castle, 108, Gasan digital 2-ro, Geumcheon-gu, Seoul, REPUBLIC OF KOREA Tel: +82-2-704-2876 Fax: +82-2-704-2877
2. Submission Contact Person
MTech Group Inc. 7707 Fannin St. Ste 200, V111, Houston, TX 77054 Mr. Dave Kim Phone: 713-467-2607 Email: davekim@mtech-inc.net
3. Device
- Trade / Device Name : Bio-TackS Orthodontic Mini Implant
- Classification Name : Implant, Endosseous, Orthodontic
- Regulation Number : 21 CFR 872.3640
- Regulation Name : Endosseous dental implant
- Regulatory Class : II
- Product Code : OAT
4. Predicate Device
- Trade / Device Name : Orthodontic Screw
- 510(k) Number : K161197
- Regulation Number : 21 CFR 872.3640
- Regulation Name : Endosseous dental implant
- Regulatory Class : II
- Product Code : OAT
5. Description:
Fixed on jawbone the Bio-TackS Orthodontic Mini Implant is a screw-shaped product used as a fixed point for orthodontic treatment and it is applied in order to secure sufficient physical and mechanical fixing source for treatment.
6. Indications for Use
The Bio-TackS Orthodontic Mini Implant is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
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7. Substantial Equivalence Discussion:
The Bio-TackS Orthodontic mini implant is substantially equivalent to Osstem Orthodontic Screw (K161197). The following comparison table is presented to demonstrate substantial equivalence.
| | Subject Device | Predicate 1 | SE
Analysis |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 510(k) Number | K190871 | K161197 | - |
| Device Name | Bio-TackS Orthodontic Mini Implant | Orthodontic Screw | - |
| Common Name | Orthodontic mini implant | Orthodontic mini implant | - |
| Manufacturer | BIOCETEC CO., LTD. | OSSTEM Implant Co., Ltd. | - |
| Design | Details refer to below Table(*) | - | - |
| Indication for Use | The Bio-TackS Orthodontic mini implant is indicated for
use as a fixed anchorage point for attachment of
orthodontic appliances to facilitate the orthodontic
movement of teeth. It is used temporarily and is removed
after orthodontic treatment has been completed. Screws are
intended for single use only. | The Orthodontic Screw is indicated for use
as a fixed anchorage point for attachment of
orthodontic appliances to facilitate the
orthodontic movement of teeth. It is used
temporarily and is removed after
orthodontic treatment has been completed.
Screws are intended for single use only. | SE |
| Head Structure | Simple Head, Through Hole, Small Head, Bracket Head,
Hex Head, Hex Cross, Hex Open Cross, Simple Head Hex
Stopper, Small Head Hex Stopper, Through Hole Stopper | Simple Head, Through Hole, Small Head,
Bracket Head | Different |
| Body Diameter | Ø 1.4mm,
Ø 1.6mm, Ø 1.8mm | Ø1.2mm, Ø 1.4mm,
Ø 1.6mm, Ø 1.8mm | SE |
| Length | 6mm, 8mm, 10mm | 6mm, 8mm, 10mm | SE |
| Material of Fixture | Ti-6Al-4V ELI
[ASTM F136] | Ti-6Al-4V ELI
[ASTM F136] | SE |
| Surface Treatment | Machined | Machined | SE |
| Sterilization | Radiation | Radiation | SE |
| Shelf-life | 5 years | 8 years | - |
| Target Population | Professional use only - qualified dentists. Strictly reserved
to specialized and trained users. | Professional use only - qualified dentists.
Strictly reserved to specialized and trained
users. | SE |
| Principles of
operation | Orthodontic screw is inserted into either jaw to help the
orthodontist move the correct teeth and stop the wrong
teeth from moving in the wrong direction. | Orthodontic screw is inserted into either jaw
to help the orthodontist move the correct
teeth and stop the wrong teeth from moving
in the wrong direction. | SE |
| Single use | Yes | Yes | SE |
| Sterile Packaging | Yes | Yes | SE |
| Target Population | Patients in need of Dental orthodontics, maxillofacial
surgery | Patients in need of Dental orthodontics,
maxillofacial surgery | SE |
| Anatomical Site | Teeth | Teeth | SE |
| Location of Use | Use only by professional orthodontists | Use only by professional orthodontists | SE |
| Bio-compatibility | All user directly contacting materials are compliance with
ISO10993 requirements. | All user directly contacting materials are
compliance with ISO10993 requirements. | SE |
(※) Images(Photos) of each type
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| No | Type | External Appearance |
|---|---|---|
| 1 | Orthodontic Screw Simple Head | |
| type | Image: Orthodontic Screw Simple Head | |
| 2 | Orthodontic Screw Through Hole | |
| type | Image: Orthodontic Screw Through Hole | |
| 3 | Orthodontic Screw Small head | |
| type | Image: Orthodontic Screw Small head | |
| 4 | Orthodontic Screw Bracket Head | |
| type | Image: Orthodontic Screw Bracket Head | |
| 5 | Orthodontic Screw Hex Head | |
| type | Image: Orthodontic Screw Hex Head | |
| 6 | Orthodontic Screw Hex Cross | |
| type | Image: Orthodontic Screw Hex Cross |
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Image /page/6/Picture/1 description: The image shows a close-up of an orthodontic screw. The screw has a hex open cross type head. The number 7 is also present in the image, likely indicating a product or item number.
Diameter-Length Combinations (in mm) for the Proposed Device:
Ø 1.6mm, Ø 1.8mm
-
- 1.4x6. 1.4x8
-
- 1.6x6, 1.6x8, 1.6x10
-
- 1.8x6. 1.8x8. 1.8x10
Bio-TackS Orthodontic Mini Implant and the predicate device (Osstem Orthodontic Screw (K161197)) have identical indication for use statements and the same intended use.
It shows equivalent specifications with the predicate devices in most of parameters.
| However, there are differences in the device design characteristics (Head structure). | ||
|---|---|---|
| Bio-TackS | Orthodontic Screw (K161197) | |
| Body Diameter | Ø 1.4mm. | |
| 011 1 1 1 0 1 0 1 0 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Ø1.2mm. Ø 1.4mm. | |
| 011 1 1 1 0 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
The different head structure for the subject device include Hex Head, Hex Cross, Hex Open Cross, Simple Head Hex Stopper, Small Head Hex Stopper, Through Hole Stopper.
Ø 1.6mm, Ø 1.8mm
8. Performance Tests (Non-clinical)
Non-clinical performance tests were performed according to the test standard, ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
The following tests for performance of the subject device have been conducted;
Sterilization and Shelf Life:
Sterilization validation was performed according to ISO 11137-1. ISO 11137-2, and ISO 11137-3 using the VDmax25 method. Shelf life of the packaging was demonstrated by accelerated aging of the product with evaluations for seal peeling (ASTM F88), dye penetration (ASTM F1929), and sterility testing.
Insertion-Removal torque test
According to the test standard (ASTM F543-07 A1), Insertion torque / removal torque testing is performed to evaluate the mechanical stability of orthodontic mini implants. The largest diameter (1.8mm) and longest (10mm) screws are tested as the worst case; BSH1810S (BioTackS), OSSH1810 (Osstem Mini Implant). With the same diameter and length, both samples demonstrated almost equivalent torque values when inserted and removed at 1440 degrees at 1 rpm. A slight difference in the results is due to the different in drill-bit design and thread design.
Rotational fracture torque strength test
According to the test standard (ASTM F543-07 A1), Rotational fracture torque testing is performed to determine the material yield strength. The smallest diameter (1.4mm) with a 10mm length; BSH1408S (BioTacks), OSSH1408 (Osstem mini implant) were tested. The tapered implant fracture occurred in the same tread section. Both implants are made from the same raw material (titanium alloy-ELI grade 23), so the material yield strengths of both products are the same.
7
In addition, all screw-head types, with the same diameter and length, are tested.
Axial pull-out strength testing
According to the test standard (ASTM F543-07 A1), Pull-out strength testing is performed for the effectiveness of the mechanical design of the orthodontic mini implant and its elimination. The screw samples with the shortest (6mm) and smallest diameter (1.4mm) were tested: BSH1406S (BioTackS). OSSH1406 (Osstem mini implant). The test data demonstrated similar results due to the similar pitch tread thickness of the samples.
| Test | Type | Diameter | Length | Shape |
|---|---|---|---|---|
| Insertion-Removal torque testing | BSH1810S | |||
| (BioTackS) | 1.8 mm | 10 mm | Taper | |
| OSSH1810 | ||||
| (Osstem) | 1.8 mm | 10 mm | Taper | |
| Rotational fracture torque testing | BSH1408S | |||
| (BioTackS) | 1.4 mm | 8 mm | Taper | |
| OSSH1408 | ||||
| (Osstem) | 1.4 mm | 8 mm | Taper | |
| Axial Pull-out strength testing | BSH1406S | |||
| (BioTackS) | 1.4 mm | 6 mm | Taper | |
| OSSH1406 | ||||
| (Osstem) | 1.4 mm | 6 mm | Taper |
Table 1. Description of orthodontic mini implant Used in This Study
Bench Test included rotational fracture torque strength testing for all screw-head types, with the same diameter and length. The test results were similar. Differences of Head structure do not affect effectiveness or safety of the Bio-TackS Orthodontic Mini Implant and Predicate Device.
The results of the bench testing demonstrate similar performance for Bio-TackS Orthodontic Mini Implant and the predicate device.
Biocompatibility testing accordance with ISO 10993-1 has been conducted for Bio-TackS Orthodontic Mini Implant.
- Category : Implant Device for Tissue / Bone
- Contact duration: C-permanent (>30d)
| Human
| Contact Part | Test Item | Test Report Number | Test Standard | Test Result |
|---|---|---|---|---|
| Tissue / Bone | Cytotoxicity | 180600062 PPT-18-0028-01(E) | ISO 10993-5 | Non-cytotoxic |
| Acute Systemic Toxicity | 180600062 PPT-18-0028-02(E) | ISO 10993-11 | Non-acute systemic toxicity | |
| Intracutaneous | ||||
| (Intradermal) Reactivity | 180600062 PPT-18-0028-03(E) | ISO 10993-10 | None Irritation | |
| Local Lymph Node | ||||
| Assay (LLNA) | 180600062 PPT-18-0028-04(E) | ISO 10993-10 | Do not show any hypersensitivity |
Biocompatibility testing including Cytotoxicity, Sensitization or Intracutaneous Reactivity, Systemic Toxicity was completed according to the following standards:
ISO 10993-1:2009 Biological Evaluation of Medical Devices -Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5 Cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity test
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The biocompatibility test results demonstrated that there is no new concern in the cytotoxicity, acute systemic toxicity, intracutaneous reactivity, local lymph node assay (LLNA).
Subchronic Toxicity Test, Genotoxicity Test, Implantation were not conducted due to the reasons as follows;
Products with titanium materials tested according to the contents of ASTM F 136, X2. BIOCOMPATIBILITY in Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications of ASTM F136 do not have side effects on safety after a procedure.
X2. BIOCOMPATIBILITY
- X2.1
The alloy composition covered by this specification has been employed successfully in human implant annlications in contact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981.
SUMMARY OF CLINICAL TESTS 9.
Clinical testing was not required to demonstrate the substantial equivalence of the Bio-TackS Orthodontic Mini Implant to its predicate device.
10. Conclusions:
Based on the information above, Bio-TackS Orthodontic Mini Implant has same indications for use and intended use. Both the subject device and the predicate / reference devices have shown similar performance results in these bench tests
In conclusion, Bio-TackS Orthodontic Mini Implant is substantially equivalent to the predicate device as described herein.