(83 days)
No
The device description and performance studies focus on the physical properties, materials, and mechanical testing of a dental implant, with no mention of AI or ML.
Yes
The device (S-mini active Fixture) is indicated for use in the treatment of missing teeth to restore chewing function, which addresses a medical condition (missing teeth/partial edentulism) and provides a direct health benefit by restoring function. This aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "temporary support prosthetic device" and a "mini implant" used to "restore chewing function". Its function is to support artificial teeth during healing, not to diagnose a condition or disease.
No
The device description clearly states it is a physical implant made of Ti-6Al-4V ELI, designed to be placed in bone. It also details physical characteristics like dimensions, surface treatment, and mechanical testing. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in the treatment of missing teeth to serve as temporary support for prosthetic devices during the healing phase of permanent implants. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant made of titanium alloy that is placed in the alveolar bone. This is an implantable medical device.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as:
- Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L) .
- Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
- . Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors or the mandibular central and lateral incisors, alveolar bone, mandibular or maxillary bone
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 testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- . Bench testing such as visual test, dimension test, compressive loads, fatigue, adaptation accuracy, and torque tests
- Fatigue Testing according to ISO 14801:2007 under the worst-case scenario
- . Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device. Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K112540. Fatigue evaluation was performed with the angled abutment of the predicate device under the worstcase scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". The SLA surface assessment such as SEM and Chem Analysis was provided in our reference predicate device, K120503 and it is exactly same for the subject device. Sterilization Validation and Shelf Life testing performed on device with the same raw material, surface treatment method, cleaning condition and packing methods as the the subject device and it demonstrates the sterilization and packing validation safety of the subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2018
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K181178
Trade/Device Name: S-mini active Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 26, 2018 Received: May 2, 2018
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Expiration Date: 06/30/2020 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known) K181178
Device Name S-mini active Fixture
Indications for Use (Describe)
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
Submitter
Neobiotech Co., Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: kylee@neobiotech.com Tel. +82-2-582-2885 Fax. +82-2-582-2883
Device Information
- Trade Name: S-mini active Fixture
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form
- . Primary Product Code: DZE
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: 07/23/2018
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
. K112540, S-Mini Implant system manufactured by Neobiotech Co., Ltd.
Reference Predicates -
K122171, MS SA Implant System by OSSTEM Implant Co.,Ltd. .
-
K120503, CMI IMPLANT IS II ACTIVE by Neobiotech Co., Ltd. ●
Indication for Use:
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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Device Description
S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136.
The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching).
It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping.
The fixtures' diameters and lengths are available as:
- Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L) .
- Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
- . Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.
Materials:
The fixture is fabricated from Ti-6A1-4V ELI of ASTM F136.
Summary of Technological Characteristics
1) S-mini active Fixture
| Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd | OSSTEM Implant Co.,Ltd. |
| Device Name | S-mini active Fixture | S-Mini Implant system | MS SA Implant System |
| 510(k) Number | K181178 | K112540 | K122171 |
| Device | |||
| Classification | |||
| Name | Implant, Endosseous, | ||
| Root-Form | Implant, Endosseous, | ||
| Root-Form | Endosseous, Dental Implant | ||
| Product Code | DZE | DZE | DZE |
| Regulation | 872.3640 | 872.3640 | 872.3640 |
| Intended Use | The S-mini active Fixture is | ||
| indicated for use in the | |||
| treatment of missing maxillary | |||
| lateral incisors or the | |||
| mandibular central and lateral | |||
| incisors to serve as temporary | |||
| support prosthetic devices | |||
| during the healing phase of | |||
| permanent endosseous dental | |||
| implant, such as artificial | |||
| teeth, in order to restore | |||
| chewing function in partially | |||
| edentulous patients. | The S-Mini Implant System | ||
| divided into two types: | |||
| Cemented Type |
The Cement type is indicated
for use in the treatment of
missing maxillary lateral
incisors or the mandibular
central and lateral incisors to
serve as temporary support
prosthetic devices during the
healing phase of permanent
endosseous dental implant, such
as artificial teeth, in order to | The MS SA Implant(Narrow
Ridge) is intended to use in
the treatment of missing
mandibular central and
lateral incisors to support
prosthetic device, such as
artificial teeth, in order to
restore chewing function in
partially edentulous patients.
The MS SA Implant(Narrow
Ridge) is intended for single
use only. It is intended for
delayed loading |
5
| | | restore chewing function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery.
Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only. | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI of ASTM F136 | Pure Titanium of ASTM F67 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: dental implant | Image: dental implant | Image: dental implant |
| Diameters (Ø) | 2.5/3.0/3.5 | 2.0/2.5/3.0/3.5 | 2.5/2.9 |
| Lengths (mm) | 7.0/8.5/10.0/11.5/13.0/15.0 | 7.0/8.5/10.0/11.5/13.0/15.0 | 8.5/10.0/11.5/13.0 |
| Surface
Treatment | SLA | RBM | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of
Operation | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. |
| Shelf Life | 5 Years | 5 Years | 5 Years |
Similarities:
The S-mini active Fixture has same device characteristics with the Primary predicate devices, S-Mini Implant System (K112540) such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar.
The subject device has been supposed to performance and product validations prior to release. Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance.
Differences:
The differences between the subject device and the primary predicate device are indications for use, surface treatment and dimensions. The indications for use of the subject and predicates are different because of the removal of ball abutments in the subject device.
The surface treatment method of the subject fixture is SLA (Sandblasted with Large-grit and Acidetching) and the surface treatment method of the primary Predicate device is RBM (Resorbable Blasting Media) To support this discrepancy, K122171 was selected as reference predicate for the fixtures and biocompatibility testing was performed on the subject device. The dimension is slightly different from the predicate devices. However, this dimensional difference doesn't affect device safety and effectiveness.
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Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- . Bench testing such as visual test, dimension test, compressive loads, fatigue, adaptation accuracy, and torque tests
- Fatigue Testing according to ISO 14801:2007 under the worst-case scenario
- . Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K112540.
Fatigue evaluation was performed with the angled abutment of the predicate device under the worstcase scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The SLA surface assessment such as SEM and Chem Analysis was provided in our reference predicate device, K120503 and it is exactly same for the subject device.
Sterilization Validation and Shelf Life testing performed on device with the same raw material, surface treatment method, cleaning condition and packing methods as the the subject device and it demonstrates the sterilization and packing validation safety of the subject device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
S-mini active Fixture constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, S-mini active Fixture and its predicates are substantially equivalent.