(248 days)
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.
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.
The provided text is a 510(k) summary for the INNO SLA Mini Plus® Implant System, which establishes substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study for performance. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.
However, I can extract the non-clinical performance data and related information as presented.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of acceptance criteria with corresponding device performance metrics from a formal study. Instead, it describes various non-clinical tests conducted or leveraged to demonstrate substantial equivalence to predicate devices. These tests primarily focus on material properties, manufacturing processes, and safety aspects.
| Acceptance Criteria (Implied) | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | Leveraged K201323; Biocompatibility tests performed and results support substantial equivalence. |
| Shelf Life | Leveraged K132242. |
| Sterilization Validation | Leveraged K201323. Sterilization validation test conducted for POM caps & Nylon caps per ISO 17665-1 and ISO 17665-2. |
| Endotoxin Limit | Endotoxin testing to be conducted on random batch every two months using Limulus amebocyte lysate (LAL) test (gel-clot technique). |
| Fatigue Testing | Not required as no angled abutments in the submission. |
| MRI Safety | Non-clinical worst-case MRI review conducted. Scientific literature (Kim et al., Woods et al.) and ASTM standards (F2052, F2213, F2182, F2119) referenced to confirm stability of CP Ti Gr.4 in MRI environment and address FDA guidance. |
| Material (CP Ti Gr.4) | Confirmed stability in MRI environment. |
| Material (POM caps, Nylon caps) | Sterilization validation achieved. |
| Manufacturing (SLA surface treatment) | Leveraged K132242. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes non-clinical tests, and for those, the "sample size" would refer to the number of units tested. This detail is not present. Data provenance (country of origin, retrospective/prospective) is also not applicable or not disclosed for these non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. This document focuses on demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of characteristics, not through a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple readers or assessors, which is not described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. The device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental implant system, not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Biocompatibility/Chemical Analysis: The ground truth would be established by industry standards and regulatory requirements for safe material interaction with biological systems.
- Sterilization Validation: Ground truth is established by meeting the sterility assurance level (SAL) defined by ISO standards.
- Shelf Life: Ground truth is established by assessing material degradation over time under specific conditions.
- Endotoxin Testing: Ground truth is established by meeting specified pyrogen limits.
- MRI Safety: Ground truth is established by referenced scientific literature and adherence to ASTM standards and FDA guidance for MR safety, which define acceptable parameters for magnetic field interaction, heating, and artifact generation.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would have involved a sample size of the physical device components, but these details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
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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.
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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.
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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
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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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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.
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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.
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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 TypeINNO 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 dividedinto two types:- Cemented TypeThe Cement type isindicated for use in thetreatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to serve astemporary supportprosthetic devices duringthe healing stage ofpermanent endosseousdental implant, such asartificial teeth, in order torestore masticating functionin partially edentulouspatients.The Cemented Type implantbodies are indicated forimmediate loading whengood primary stability isachieved and with | The Cemented type isindicated for use in thetreatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to serve astemporary support prostheticdevices during the healingphase of permanentendosseous dental implant,such as artificial teeth, inorder to restore chewingfunction in partiallyedentulous patients. | The MS System (NarrowRidge) is intended to usein the treatment of missingmandibular central andlateral incisors to supportprosthetic device, such asartificial teeth, in order torestore chewing functionin partially edentulouspatients. MS System(Narrow Ridge) isintended for single useonly. It is not forimmediate loading. |
7.1. Mini Plus Fixture – Cement Type
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| appropriate occlusalloading. | |||
|---|---|---|---|
| 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 |
| Gingivalheights/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 ofoperation | This product is a root-type fixture which isinserted in the alveolarbone. It replaces thefunctions of the missingteeth as a dental implantfixture. | This product is a root-typefixture which is inserted inthe alveolar bone. It replacesthe functions of the missingteeth as a dental implantfixture. | This product is a root-typefixture which is inserted inthe alveolar bone. It replacesthe functions of the missingteeth as a dental implantfixture. |
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| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K232104 | K112540 |
| Device Name | Mini Plus Fixture - Ball TypeINNO SLA Mini Plus® ImplantSystem | S-Mini Implant System |
| Manufacturer | Cowellmedi Co., Ltd. | Neobiotech Co., Ltd |
| Intended Use | The INNO SLA Mini Plus® ImplantSystem is divided into two types:- Ball TypeThe Ball type is designed for use indental implant surgery. The Ball typeis intended for use in partially or fullyedentulous mandibles and maxillae, insupport of overdentures. The use ofthe Ball type implants is not to exceedone hundred and eighty (180) days.The Ball Type implant bodies areindicated for immediate loading whengood primary stability is achieved andwith appropriate occlusal loading. | The Ball type is designed for use indental implant surgery. Ball type isintended for use in partially or fullyedentulous mandibles and maxillae,in support of overdentures. Ball typeimplants 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 |
| Gingivalheights/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 ofoperation | This product is a root-type fixturewhich is inserted in the alveolar bone.It replaces the functions of the missingteeth as a dental implant fixture. | This product is a root-type fixturewhich is inserted in the alveolar bone.It replaces the functions of themissing teeth as a dental implantfixture. |
| Subject Device | Predicate Device | |
| 510(k) Number | K232104 | K210161 |
| Device Name | Protection CapINNO SLA Mini Plus® ImplantSystem | Solid Post CapFor AnyOne Onestage ImplantSystem |
| Manufacturer | Cowellmedi Co., Ltd. | MegaGen Implant Co., Ltd. |
| Intended Use | The INNO SLA Mini Plus® ImplantSystem is divided into two types:- Cemented TypeThe Cement type is indicated for usein the treatment of missing maxillarylateral incisors or the mandibularcentral and lateral incisors to serveas temporary support prostheticdevices during the healing stage ofpermanent endosseous dentalimplant, such as artificial teeth, inorder to restore masticating functionin partially edentulous patients.- Ball TypeThe Ball type is designed for use indental implant surgery. The Balltype is intended for use in partiallyor fully edentulous mandibles andmaxillae, in support of overdentures.The use of the Ball type implants isnot to exceed one hundred andeighty (180) days.The Cemented Type and Ball Typeimplant bodies are indicated forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading. | The AnyOne Onestage ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular arches for the purpose ofproviding prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated for themolar 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 ofoperation | The Protection Cap is used forprotecting a MiniPlus cemented typefixture, and minimizing irritation totongue, gingiva and oral mucosa. | The Solid Post Cap is used forprotecting a Solid Post Abutmentafter taking impression, andminimizing irritation to tongue andoral mucosa. |
7.2. Mini Plus Fixture - Ball Type
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7.3. Protection Cap
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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 capINNO SLA Mini Plus® ImplantSystem | 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 twotypes:- Cemented TypeThe Cement type is indicated for usein the treatment of missingmaxillary lateral incisors or themandibular central and lateralincisors to serve as temporarysupport prosthetic devices duringthe healing stage of permanentendosseous dental implant, such asartificial teeth, in order to restoremasticating function in partiallyedentulous patients.- Ball TypeThe Ball type is designed for use indental implant surgery. The Ball | The LOCATOR R-Tx®Attachment System is designedfor use with overdentures orpartial dentures, retained inwhole or in part, by endosseousimplants in the mandible ormaxilla. |
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| type is intended for use in partiallyor fully edentulous mandibles andmaxillae, in support ofoverdentures. The use of the Balltype implants is not to exceed onehundred and eighty (180) days.The Cemented Type and Ball Typeimplant bodies are indicated forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading. | |||
|---|---|---|---|
| Design | AbutmentDiameter(mm) | 3.4 | 2.75 - 6.0 |
| AbutmentAngle | Straight | Straight | |
| Material | Abutment | Image: Abutment | Ti-6Al-4V ELI |
| ProstheticRetentionComponent | Image: Prosthetic Retention Component | Nylon or Peek | |
| Product Code | NHA | NHA | |
| Regulation | 872.3630 | 872.3630 | |
| Principle of operation | Abutment design that connects to ahousing embedded in a dentureridge, which nylon inserts are usedto allow connection anddisconnection of the denture to theabutment for "removable" denturesolution for the patient | Abutment design that connectsto a housing embedded in adenture ridge, which nyloninserts are used to allowconnection and disconnection ofthe denture to the abutment for"removable" denture solution forthe 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.
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- 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.
§ 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.