Who is the manufacturer of INNO SLA Mini Plus® Implant System?

Cowellmedi Co., Ltd. filed the 510(k) submission for INNO SLA Mini Plus® Implant System (K241127).

What is the FDA product code for INNO SLA Mini Plus® Implant System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for INNO SLA Mini Plus® Implant System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like INNO SLA Mini Plus® Implant System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INNO SLA Mini Plus® Implant System

Q: What are the predicate devices for INNO SLA Mini Plus® Implant System?

S-Mini Implant System (K112540).

K241127 · Cowellmedi Co., Ltd. · DZE · Dec 27, 2024 · Dental

Device Facts

Record ID	K241127
Device Name	INNO SLA Mini Plus® Implant System
Applicant	Cowellmedi Co., Ltd.
Product Code	DZE · Dental
Decision Date	Dec 27, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

One-piece endosseous dental implant system comprising implant and abutment sections; fabricated from commercially pure titanium with S.L.A. surface treatment. Used in dental implant surgery by clinicians to restore masticating function. Cemented type serves as temporary support during healing of permanent implants; Ball type supports overdentures in partially or fully edentulous patients. Implant inserted into alveolar bone; Ball type connects to housing embedded in denture ridge via nylon inserts for removable solutions. Clinicians evaluate stability and occlusal loading to determine suitability for immediate loading. Benefits include restoration of chewing function and prosthetic support. MRI safety confirmed via literature and non-clinical assessment of titanium material properties.

Clinical Evidence

Bench testing only. Includes biocompatibility testing, chemical analysis, sterilization validation (ISO 17665-1/2), and shelf-life testing. MRI safety evaluated via literature review and assessment of titanium material properties per ASTM F2052, F2213, F2182, and F2119. Endotoxin testing performed via LAL gel-clot technique.

Technological Characteristics

One-piece root-form endosseous dental implant. Material: Commercially pure titanium (Grade 4). Surface: S.L.A. treatment. Diameters: 2.5/3.0 mm. Lengths: 10.0/12.0/14.0 mm. Sterilization: Gamma (implants) and Steam (caps). Connectivity: Mechanical connection to denture housing. No software or electronics.

Indications for Use

Indicated for partially or fully edentulous patients requiring temporary prosthetic support (Cemented Type) or overdenture support (Ball Type) in the maxilla or mandible. Cemented type specifically for missing maxillary lateral incisors or mandibular central/lateral incisors. Ball type limited to 180 days use. Both types indicated for immediate loading given sufficient primary stability.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

S-Mini Implant System (K112540)

Reference Devices

AnyOne Onestage Implant System (K210161)
The LOCATOR R-Tx® Attachment System (K200827)
INNO SLA Submerged Implant System (K201323)
INNO SLA Submerged Implant System (K132242)
MS System (K083067)

Related Devices

K112540 — S-MINI IMPLANT SYSTEM · Neobiotech Co., Ltd. · Feb 3, 2012
K222131 — NB 1 SA Implant System · Arum Dentistry Co., Ltd. · Sep 19, 2022
K221910 — QRS Dental Implants System · Qrs Medical , Ltd. · Dec 14, 2022
K071161 — ENDOSSEOUS DENTAL IMPLANT SYSTEM · Southern Implants, Inc. · Nov 16, 2007
K133706 — ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM · Zl Microdent-Attachment GmbH & Co. KG · Aug 21, 2014

Submission Summary (Full Text)

{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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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…