(248 days)
No
The summary describes a dental implant system made of titanium with a specific surface treatment. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties, sterilization, and MRI safety, not on algorithmic performance.
Yes
The device is described as an "Implant System" used to restore "masticating function" in partially edentulous patients and to support overdentures, directly addressing a health condition by replacing missing teeth and improving oral function.
No
The document describes a dental implant system used for restoring masticating function and supporting overdentures, not for diagnosing a medical condition.
No
The device description clearly states it is a "one-piece endosseous dental implant" made of "commercially pure titanium," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for dental procedures, specifically supporting prosthetic devices and overdentures. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed in the jawbone. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the INNO SLA Mini Plus® Implant System is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INNO SLA Mini Plus® Implant System is 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 stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exceed one hundred and eighty (180) days.
The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary lateral incisors, mandibular central and lateral incisors, partially or fully edentulous mandibles and maxillae.
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)
Performance Data (Non-Clinical): 8.
- Leveraged K201323 for sterilization validating and biocompatibility tests
- Leveraged K132242 for shelf life test and SLA surface treatment analysis
- Sterilization validation test for POM caps and Nylon caps in accordance with ISO 17665-1 and ISO 17665-2
- The endotoxin testing will be conducted on a random batch every two months for the subject device. The test method to verify pyrogen limit specifications will be the Limulus amebocyte lysate (LAL) test. We are planning to apply gel-clot technique (limit test and assay method) among currently three commonly accepted BET techniques (ANSVAAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Annex B).
- Fatigue testing was not required as there are no angled abutments in the subject submission.
- MRI Safety
A non-clinical worst-case MRI review was conducted to evaluate the INNO SLA Mini Plus® Implant System in an MRI environment. Various dental journals were utilized to ensure its stability, and scientific evidence from literature was considered, such as the study by Yong-Ha Kim, Manki Choi, and Jae-Won Kim titled 'Are titanium implants actually safe for magnetic resonance imaging examinations?' (Arch Plast Surg 2019;46:96-97). The study concluded that titanium, being a paramagnetic material, is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants. Based on this paper, the stability of the raw material of the INNO SLA Mini Plus® Implant System in an MRI environment was confirmed.
In the study conducted by Woods, Terry O., Jana G. Delfino, and Sunder Rajan titled "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), Titanium Grade 4 was evaluated using magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) tests by T. O. Woods et al. Based on this research, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
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.
K210161, K200827, K201323, K132242, K083067
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 U.S. Food & Drug Administration. 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.
Cowellmedi Co., Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine. California 92612
December 27, 2024
Re: K241127
Trade/Device Name: INNO SLA Mini Plus® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 14, 2024 Received: December 3, 2024
Dear Priscilla Chung:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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 -S
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
3
Indications for Use
510(k) Number (if known) K241127
Device Name
INNO SLA Mini Plus® Implant System
Indications for Use (Describe)
The INNO SLA Mini Plus® Implant System is divided into two types:
- Cemented Type
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors to serve as temporary support prosthetic devices during stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exeed one hundred and eighty (180) days.
The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| 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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4
510(k) Summary (K241127)
This summary of 510(k)-substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Dec 26, 2024
1. Applicant / Submitter:
Cowellmedi Co., Ltd. 48, Hakgam-daero 221beon-gil, Sasang-gu, Busan, 46986. Republic of Korea Tel. + 82-51-314-2028
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
Subject Device: 3.
Proprietary Name: INNO SLA Mini Plus® Implant System Common Name: Endosseous dental implant Device Classification: II Regulation Number: 21 CFR 872.3640 Device Name: Implant, Endosseous, Root-Form Classification Product Code: DZE, NHA
4. Predicate Devices:
- . Primary Predicate: S-Mini Implant System (K112540) by Neobiotech Co., Ltd.
- Reference Device: AnyOne Onestage Implant System (K210161) by MegaGen Implant Co., Ltd. .
- . Reference Device: The LOCATOR R-Tx® Attachment (K200827) System by Zest Anchors, LLC
- Reference Device: INNO SLA Submerged Implant System (K201323) by Cowellmedi Co., Ltd. .
- Reference Device: INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd. .
- · Reference Device: MS System (K083067) by Osstem Implant Co., Ltd.
5
5. Device Description:
The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.
6. Indications for Use:
The INNO SLA Mini Plus® Implant System is 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 stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exceed one hundred and eighty (180) days.
The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
7. Substantial Equivalence
Substantial Equivalence Discussion
The Cement Type of INNO SLA Mini Plus® Implant System has the same device characteristics as the predicate device, S-Mini Implant System (K112540) by Neobiotech Co., Ltd. and MS System (K083067) by Osstem Implant Co., Ltd. in terms of intended use, design and use concept. The size range of the predicate device and the reference devices encompasses the subject device.
Same for the Ball Type, the INNO SLA Mini Plus® Implant System has the same device characteristics as the predicate device, S-Mini Implant System (K112540) by Neobiotech Co., Ltd in terms of intended use, design and use concept. The size range of the predicate device encompasses the subject device.
For the implants, the difference is the surface treatment; however, the biocompatibility and chemical analysis were performed and the test results support substantial equivalence.
6
The subject cap and ball attachments have the same intended use, design, raw material, and the technical characteristics as the predicate device. We performed the biocompatibility test and determine the subject components does not raise a question in substantial equivalence.
Lastly, we presented two references devices which are made by our company to be leveraged for biocompatibility and shelf life tests.
Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate device.
Comparison Chart
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | K232104 | K112540 | K083067 |
| Device Name | Mini Plus Fixture - | ||
| Cement Type | |||
| INNO SLA Mini Plus® | |||
| Implant System | S-Mini Implant System | MS System | |
| Manufacturer | Cowellmedi Co., Ltd. | Neobiotech Co., Ltd. | Osstem Implant Co., Ltd. |
| Intended Use | The INNO SLA Mini Plus® | ||
| Implant System is 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 stage of
permanent endosseous
dental implant, such as
artificial teeth, in order to
restore masticating function
in partially edentulous
patients.
The Cemented Type implant
bodies are indicated for
immediate loading when
good primary stability is
achieved and with | The Cemented 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 restore chewing
function in partially
edentulous patients. | The MS System (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. MS System
(Narrow Ridge) is
intended for single use
only. It is not for
immediate loading. |
7.1. Mini Plus Fixture – Cement Type
7
| | appropriate occlusal
loading. | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: Dental implant | Image: Dental implant | Image: Dental implant |
| Diameters(Ø) | 2.5/3.0 | 2.0/2.5/3.0/3.5 | 3.0 |
| Lengths(mm) | 10.0/12.0/14.0 | 7.0/8.5/10.0/11.5/13.0/15.0 | 10.0/13.0/15.0 |
| Gingival
heights/cuffs(mm) | 2.0/4.0 | 2.0 | 2.5/4.0 |
| Product Code | DZE | DZE | DZE |
| Regulation | 872.3640 | 872.3640 | 872.3640 |
| Surface treatment | SLA | RBM | RBM |
| Sterility | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Angulation | 0° | 0° | 0° |
| Material | CP Ti Gr.4 | CP Ti Gr.4 | Ti 6Al 4V ELI |
| 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. |
8
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K232104 | K112540 |
| Device Name | Mini Plus Fixture - Ball Type | |
| INNO SLA Mini Plus® Implant | ||
| System | S-Mini Implant System | |
| Manufacturer | Cowellmedi Co., Ltd. | Neobiotech Co., Ltd |
| Intended Use | The INNO SLA Mini Plus® Implant | |
| System is divided into two types: |
- Ball Type
The Ball type is designed for use in
dental implant surgery. The Ball type
is intended for use in partially or fully
edentulous mandibles and maxillae, in
support of overdentures. The use of
the Ball type implants is not to exceed
one hundred and eighty (180) days.
The Ball Type implant bodies are
indicated for immediate loading when
good primary stability is achieved and
with appropriate occlusal loading. | 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. |
| Design | Image: Mini Plus Fixture - Ball Type | Image: S-Mini Implant System |
| Diameters(Ø) | 2.5/3.0 | 2.0/2.5/3.0/3.5 |
| Lengths(mm) | 10.0/12.0/14.0 | 7.0/8.5/10.0/11.5/13.0/15.0 |
| Gingival
heights/cuffs | 2.0/4.0 | 3.0/4.0 |
| Product Code | DZE | DZE |
| Regulation | 872.3640 | 872.3640 |
| Surface treatment | SLA | RBM |
| Sterility | Gamma Sterilization | Gamma Sterilization |
| Angulation | 0° | 0° |
| Material | CP Ti Gr.4 | CP Ti Gr.4 |
| 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. |
| | Subject Device | Predicate Device |
| 510(k) Number | K232104 | K210161 |
| Device Name | Protection Cap
INNO SLA Mini Plus® Implant
System | Solid Post Cap
For AnyOne Onestage Implant
System |
| Manufacturer | Cowellmedi Co., Ltd. | MegaGen Implant Co., Ltd. |
| Intended Use | The INNO SLA Mini Plus® Implant
System is 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 stage of
permanent endosseous dental
implant, such as artificial teeth, in
order to restore masticating function
in partially edentulous patients. - Ball Type
The Ball type is designed for use in
dental implant surgery. The Ball
type is intended for use in partially
or fully edentulous mandibles and
maxillae, in support of overdentures.
The use of the Ball type implants is
not to exceed one hundred and
eighty (180) days.
The Cemented Type and Ball Type
implant bodies are indicated for
immediate loading when good
primary stability is achieved and
with appropriate occlusal loading. | The AnyOne Onestage Implant
System is intended to be surgically
placed in the maxillary or
mandibular arches for the purpose of
providing prosthetic support for
dental restorations (Crown, bridges,
and overdentures) in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function
in the following situations and with
the clinical protocols:
-Delayed loading.
-Immediate loading when good
primary stability is achieved and
with appropriate occlusal loading.
Larger implants are dedicated for the
molar region. |
| Design | Image: Cylinder shape | Image: U shape |
| Diameters(Ø) | 4.05 mm | 5.3 mm |
| Lengths(mm) | 6.8 mm | 6.5, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5,
11.5 mm |
| Regulation | 872.3640 | 872.3640 |
| Sterility | Steam Sterilization | Steam Sterilization |
| Single Use | Yes | Yes |
| Material | POM | POM |
| Principle of
operation | The Protection Cap is used for
protecting a MiniPlus cemented type
fixture, and minimizing irritation to
tongue, gingiva and oral mucosa. | The Solid Post Cap is used for
protecting a Solid Post Abutment
after taking impression, and
minimizing irritation to tongue and
oral mucosa. |
7.2. Mini Plus Fixture - Ball Type
9
7.3. Protection Cap
10
7.4. Ball Attachment (Ball outer Cap, Ball Inner Cap)
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K232104 | K200827 |
| Device Name | Ball outer cap, Ball Inner cap | |
| INNO SLA Mini Plus® Implant | ||
| System | The LOCATOR R-Tx® | |
| Attachment System | ||
| Manufacturer | Cowellmedi Co., Ltd. | Zest Anchors, LLC |
| Intended Use | The INNO SLA Mini Plus® | |
| Implant System is 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 stage of permanent
endosseous dental implant, such as
artificial teeth, in order to restore
masticating function in partially
edentulous patients. - Ball Type
The Ball type is designed for use in
dental implant surgery. The Ball | The LOCATOR R-Tx®
Attachment System is designed
for use with overdentures or
partial dentures, retained in
whole or in part, by endosseous
implants in the mandible or
maxilla. |
11
| | | type is intended for use in partially
or fully edentulous mandibles and
maxillae, in support of
overdentures. The use of the Ball
type implants is not to exceed one
hundred and eighty (180) days.
The Cemented Type and Ball Type
implant bodies are indicated for
immediate loading when good
primary stability is achieved and
with appropriate occlusal loading. | |
|------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Abutment
Diameter
(mm) | 3.4 | 2.75 - 6.0 |
| | Abutment
Angle | Straight | Straight |
| Material | Abutment | Image: Abutment | Ti-6Al-4V ELI |
| | Prosthetic
Retention
Component | Image: Prosthetic Retention Component | Nylon or Peek |
| Product Code | | NHA | NHA |
| Regulation | | 872.3630 | 872.3630 |
| Principle of operation | | Abutment design that connects to a
housing embedded in a denture
ridge, which nylon inserts are used
to allow connection and
disconnection of the denture to the
abutment for "removable" denture
solution for the patient | Abutment design that connects
to a housing embedded in a
denture ridge, which nylon
inserts are used to allow
connection and disconnection of
the denture to the abutment for
"removable" denture solution for
the patient |
Performance Data (Non-Clinical): 8.
- Leveraged K201323 for sterilization validating and biocompatibility tests
- . Leveraged K132242 for shelf life test and SLA surface treatment analysis
- Sterilization validation test for POM caps and Nylon caps in accordance with ISO 17665-1 ● and ISO 17665-2
- . The endotoxin testing will be conducted on a random batch every two months for the subject device. The test method to verify pyrogen limit specifications will be the Limulus amebocyte lysate (LAL) test. We are planning to apply gel-clot technique (limit test and assay method) among currently three commonly accepted BET techniques (ANSVAAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Annex B).
- . Fatigue testing was not required as there are no angled abutments in the subject submission.
12
- MRI Safety ●
A non-clinical worst-case MRI review was conducted to evaluate the INNO SLA Mini Plus® Implant System in an MRI environment. Various dental journals were utilized to ensure its stability, and scientific evidence from literature was considered, such as the study by Yong-Ha Kim, Manki Choi, and Jae-Won Kim titled 'Are titanium implants actually safe for magnetic resonance imaging examinations?' (Arch Plast Surg 2019;46:96-97). The study concluded that titanium, being a paramagnetic material, is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants. Based on this paper, the stability of the raw material of the INNO SLA Mini Plus® Implant System in an MRI environment was confirmed.
In the study conducted by Woods, Terry O., Jana G. Delfino, and Sunder Rajan titled "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), Titanium Grade 4 was evaluated using magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) tests by T. O. Woods et al. Based on this research, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
9. Conclusion:
Based on the information provided herein, Cowellmedi Co., Ltd. concludes that the INNO SLA Mini Plus® Implant System is substantially equivalent to the predicate.