Who is the manufacturer of STERI-OSS Implant System?

Zeros Co., Ltd. filed the 510(k) submission for STERI-OSS Implant System (K232268).

What is the FDA product code for STERI-OSS 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 STERI-OSS Implant System?

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

Who can help prepare an FDA 510(k) submission like STERI-OSS 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.

STERI-OSS Implant System

K232268 · Zeros Co., Ltd. · DZE · Mar 25, 2024 · Dental

Device Facts

Record ID	K232268
Device Name	STERI-OSS Implant System
Applicant	Zeros Co., Ltd.
Product Code	DZE · Dental
Decision Date	Mar 25, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.

Device Story

STERI-OSS Implant System consists of titanium fixtures and titanium alloy abutments; inserted into maxillary or mandibular alveolar bone to support dental prostheses; restores masticatory function. Fixtures are root-form, threaded, and SLA surface-treated. System includes various abutment types (straight, solid, angled, temporary) and screws to connect prosthetics to fixtures. Used in dental clinics by dentists; surgical placement in alveolar bone. Output is a stable foundation for artificial teeth. Benefits include recovery of masticatory function and aesthetic restoration for edentulous patients.

Clinical Evidence

Bench testing only. Includes fatigue testing (ISO 14801), surface evaluation (SEM/EDS), biocompatibility (ISO 10993), sterilization validation (ISO 11137/17665), and shelf-life testing (ASTM standards). MR compatibility assessed via scientific rationale and literature.

Technological Characteristics

Materials: Pure Titanium Grade 4 (ASTM F67) for fixtures; Ti6Al4V ELI (ASTM F136) for abutments/screws. Design: Threaded, root-form, internal hex connection. Surface: SLA treated fixtures. Sterilization: Gamma irradiation. Connectivity: None (mechanical).

Indications for Use

Indicated for partially or fully edentulous mandibles and maxilla in patients requiring single or multiple-unit restorations (cemented, screw-retained, or overdenture) and terminal or intermediate abutment support for fixed bridgework. Intended for single-stage surgical procedures and delayed loading.

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

TS Fixture System (K121995)

Reference Devices

CMI Implant IS II Active (K120503)
Honorst Implant System (K202039)
Osstem Abutment System (K182091)
OSSTEM Implant System - Abutment (K161689)
URIS OMNI System (K172100)
SNUCONE Bone Level Implant System (K210354)
Implantium Abutment (K052823)
HIOSSEN Implant System (K140934)
OSSTEM Implant System (K161604)

Related Devices

K240383 — Highness Implant System · Highness Co., Ltd. · Oct 31, 2024
K233163 — ZENEX Implant System_Short · Izenimplant Co., Ltd. · Dec 19, 2023
K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
K242753 — SD TL Implant System · Arum Dentistry Co., Ltd. · Jan 6, 2025

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 Food and Drug Administration (FDA). 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. Zeros Co., Ltd. Uk Joo CTO 138-13, Pyeonggang-ro 345beon-gil Gangseo-gu, Busan 46700 REPUBLIC OF KOREA March 25, 2024 Re: K232268 Trade/Device Name: STERI-OSS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 20, 2024 Received: February 20, 2024 Dear Uk Joo: 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. 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # 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) K232268 Device Name STERI-OSS Implant System #### Indications for Use (Describe) STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed 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 Date revised : March 24, 2024 ## I. SUBMITTER Zeros Co., Ltd. 138-13, Pyeonggang-ro 345beon-gil, Gangseo-gu, Busan, 46700, Rep, of Korea TEL: +82-51-831-0094 FAX: +82-51-831-0095 Contact Name: Uk Hyon Joo Email: ecometal@nate.com ## II. DEVICE INFORMATION - Device's Trade name: STERI-OSS Implant System ● - Classification Name: Implant, Endosseous, Root-Form - Device's Common Name: Endosseous Dental Implant - . Regulation Number 872.3640 - . Class: 2 - Primary Product Code: DZE - Secondary Product Code: NHA ### III. PREDICATE DEVICE Primary Predicate Device: - K121995, TS Fixture System, OSSTEM Implant Co., Ltd. 0 Reference Device: - K120503. CMI Implant IS II Active. Neobiotech Co., Ltd. 0 - K202039, Honorst Implant System, MEDIMECCA Co., Ltd. - K182091, Osstem Abutment System, Osstem Implant Co., Ltd. - K161689, OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. - . K172100, URIS OMNI System, TruAbutment Korea Co., Ltd. - K210354, SNUCONE Bone Level Implant System, SNUCONE Co., Ltd. - K052823, Implantium Abutment, Dentium Inc. - K140934, HIOSSEN Implant System, HiOSSEN Inc. - K161604, OSSTEM Implant System, Osstem Implant Co., Ltd. # IV. DEVICE DESCRIPTION STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function. STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost. ## V. INDICATION FOR USE STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla. in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. {5}------------------------------------------------ # VI. COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE REDICATE DEVICE | Item | Subject Device | Primary Predicate Device | Reference Device | Reference Device | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K232268 | K121995 | K120503 | K202039 | | Device Name | STERI-OSS Implant System | TS Fixture System | CMI Implant IS II Active | Honorst Implant System | | Manufacturer | Zeros Co., Ltd. | Osstem Implant Co., Ltd. | Neobiotech Co., Ltd. | MEDIMECCA Co., Ltd. | | Indications for Use Statement | STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading | The TS Fixture System is designed for dental implant surgery; it is placed in the maxillary or mandibular alveolar bone through a surgical procedure, and after osseointegration with the alveolar bone, it can replace a lost tooth by connecting the abutment post. The TS Fixture System & TSIII SA Ultra-Wide Fixture are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | The CMI Implant IS II active is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices. such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading | | Substantial Equivalence Discussion | Similarity : The subject device, "STERI-OSS Implant System", and primary predicate device, 'TS Fixture System' (K121995) and reference devices 'CMI Implant IS II Active' (K120503)', 'Hornorst Implant System' (K202039) are dental implants that can recover masticatory function when teeth are lost. | | | | # Table 1 : Substantial Equivalence – Indication for Use Statements {6}------------------------------------------------ Г | Difference : Indication for use of subject device is slight differences in phrase with the primary predicate device (K121995), reference device (K120503), but fundamental indication is same. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Therefore, Indication for Use statement of the subject device, "STERI-OSS Implant System" is identical and substantially equivalent to the identified primary predicate device, K121995 and reference devices, K202039. | # Table 2 : Substantial Equivalence - EQUIVALENCE DISCUSSION # 1. Fixture | Item | Subject Device | Primary Predicate Device | Reference Device | Reference Device | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------|-----------------------------------------|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | 510(k) Number | K2322685 | K121995 | K120503 | K202039 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Name | STERI-OSS Implant System | TS Fixture System | CMI Implant IS II Active | Honorst Implant System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Manufacturer | Zeros Co., Ltd. | Osstem Implant Co., Ltd. | Neobiotech Co., Ltd. | MEDIMECCA Co., Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Design | Image: Design of STERI-OSS Implant System | Image: Design of TS Fixture System | Image: Design of CMI Implant IS II Active | Image: Design of Honorst Implant System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Connection type | Internal Hex | Internal Hex | Internal Hex | Internal Hex | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Material | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Diameter & Length | TSII SA Fixture Diameter (mm) Length(mm) 3.8 8.5, 9, 10, 11, 11.5, 12, 13, 15 4.2 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13, 15 4.6 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13, 15 5.1 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13 5.5 7, 8, 8.5, 9, 10, 11, 11.5, 12, 13 6.0 7, 8, 8.5, 9, 10, 11, 11.5, 12 | | | | | | | | | | | | | | | TSII SA Fixture Diameter (mm) Length(mm) 3.5 8.5, 10, 11.5, 13, 15 4.2 7, 8.5, 10, 11.5, 13, 15 4.4 7, 8.5, 10, 11.5, 13, 15 4.9 7, 8.5, 10, 11.5, 13, 15 TSIII SA Fixture Diameter (mm) Length(mm) 3.75 10, 11.5, 13, 15 3.77 8.5 4.2 10, 11.5, 13, 15 4.25 7, 8.5 4.6 10, 11.5, 13, 15 4.63 8.5 | | | | | | | | | | | | | | | | | | | | | | | | | Diameter (mm) Length(mm) 4.5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 5.5 7.3, 8.5, 10.0, 11.5, 13.0, 15.0 6 7.3, 8.5, 10.0, 11.5, 13.0 7 7.3, 8.5, 10.0, 11.5, 13.0 | | | | | | | | | | | | | Diameter (mm) Length(mm) 3.75 8.5, 10.0, 11.5, 13.0 4.2 7.0, 8.5, 10.0, 11.5, 13.0 4.6 7.0, 8.5, 10.0, 11.5, 13.0 5.1 7.0, 8.5, 10.0, 11.5, 13.0 5.5 7.0, 8.5, 10.0, 11.5, 13.0 6 7.0, 8.5, 10.0, 11.5, 12.5 | | | | | | | | | | | | | | | ZEROS Co., Ltd. {7}------------------------------------------------ | 5.05 10, 11.5, 13, 15 5.08 8.5 5.1 7 TSIII SA Ultra-Wide Fixture Diameter (mm) Length(mm) 5.92 11.2 5.95 9.7 6 7.2, 8.2 6.8 7.2, 8.2, 9.7, 11.2 | | | | | | | | | | | | | | | | | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------|---------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | Surface Treatment | SLA | SLA | SLA | SLA | | | | | | | | | | | | | | | | | | | | Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | | | | | | | | | | | | | | | | | | | | Shelf life | 5 years | 8 years | 5 years | 5 years | | | | | | | | | | | | | | | | | | | | Substantial Equivalence Discussion | Similarity : The subject device, "STERI-OSS Implant System" has almost the same indications for use, raw material, and design when compared to the primary predicate device, 'TS Fixture System'(K121995). The fixture surface treatment method is the same as SLA, and the product is sterilized by gamma irradiation. In addition, the subject device is the same as the reference devices 'CMI Implant IS II Active'(K120503) and 'Hornorst Implant System'(K202039) in the raw material, design, surface treatment method (SLA), and sterilization method (gamma irradiation). Difference : In addition, although there is a slight difference between the dimensions of the subject device and that of the predicate device (K121995) and reference devices (K120503, K202039), it is judged that they exist within a similar dimensional range overall. Therefore, "STERI-OSS Implant System" is similar in that they are threaded, root form implants with SLA surface treated. The subject and predicate fixtures are a similar body shape design such as cylindrical body design, similar dimension range. The difference is very minor not affecting substantial equivalence. | | | | | | | | | | | | | | | | | | | | | | # 2. Abutment | Item | Subject Device | Reference Device | Reference Device | |------------------|-----------------------------|---------------------------|--------------------------------| | 510(k) Number | K232268 | K182091 | K172100 | | Device Name | STERI-OSS Implant System | Osstem Abutment System | URIS OMNI System | | Manufacturer | Zeros Co., Ltd. | Osstem Implant Co., Ltd. | TruAbutment Korea Co., Ltd. | ZEROS Co., Ltd. {8}------------------------------------------------ | Indication for use | STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. | Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part Name | Straight Abutment | Transfer Abutment | D Basis Abutment- Cemented Type | | Design | Image: Straight Abutment | Image: Transfer Abutment | Image: D Basis Abutment | | Principle of operation | Cement retained restoration | Cement retained restoration | Cement retained restoration | | Material | Ti6Al4V ELI (ASTM F136) | Ti6Al4V ELI (ASTM F136) | Ti6Al4V ELI (ASTM F136) | | Diameter (mm) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 4.0, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.5, 5.5, 6.5 | | Post Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5. 7.0 | 4.0, 5.5, 7.0 | | Gingival Height(mm) | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 | | Surface Treatment | None | TiN Coated (partially) | None | | Substantial Equivalence Discussion | Similarity : - Subject device, "Straight Abutment" is generally used for cement-retained restoration, and has the same function, indications for use, material compared to that of the reference device, 'Transfer Abutment' in Osstem Abutment System (K182091). Also, subject device has the similar design (dimension range) and appearance compared to that of the reference device (K182091). - Indication for use of subject device is slight differences in phrase with the reference device (K182091), but fundamental indication is same. - Subject device has the same function, indications for use, material, surface treatment compared to that of the reference device (K172100). Difference : The subject device, "Straight Abutment", has a machined surface without surface treatment and is similar to the reference device (K172100). The reference device (K172100) has a TiN coated surface. | | | {9}------------------------------------------------ (K182091) was partially coated with TiN. Therefore, the subject device, "Straight Abutment" is very similar to the reference device (K182091) in terms of function, purpose of use, raw materials (Ti alloys), design, etc., except for the different surface treatment. The difference is minor not affecting substantial equivalence. | Item | Subject Device | Reference Device | Reference Device | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K232268 | K161689 | K172100 | | Device Name | STERI-OSS Implant System | OSSTEM Implant System - Abutment | URIS OMNI System | | Manufacturer | Zeros Co., Ltd. | Osstem Implant Co., Ltd. | TruAbutment Korea Co., Ltd. | | Indication for use | STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. | The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | | Part Name | Solid Abutment | Rigid Abutment | D Basis Abutment - Direct Type | | Design | Image: Solid Abutment | Image: Rigid Abutment | Image: D Basis Abutment | | Principle of operation | Cement retained restoration | Cement retained restoration | Cement retained restoration | | Material | Ti6Al4V ELI (ASTM F136) | Ti6Al4V ELI (ASTM F136) | Ti6Al4V ELI (ASTM F136) | | Diameter (mm) | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 4.0, 4.6, 5.0, 6.0, 7.0 | 4.0, 4.5, 5.5, 6.5 | | Post Height(mm) | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | ZEROS Co., Ltd. {10}------------------------------------------------ | Gingival Height(mm) | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…