ALLONUS Tech Prosthetics

K241616 · Allonus Tech Co., Ltd. · NHA · Dec 17, 2024 · Dental

Device Facts

Record IDK241616
Device NameALLONUS Tech Prosthetics
ApplicantAllonus Tech Co., Ltd.
Product CodeNHA · Dental
Decision DateDec 17, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2

Intended Use

ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations. It is compatible with the following systems: · Astra OsseoSpeed EV(K130999) 3.0 · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm · Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini, Regular) · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1) · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) · Nobel Active 3.0 (K102436) 3.0 · Nobel Active Internal Connection Implant (K071370) NP RP · Nobelactive Wide Platform (Wp) (K133731) WP · Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB) · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC) · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC) · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) · (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7) All digitally designed abutments and or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

Device Story

System of endosseous dental implant abutments including pre-milled blanks, Ti-base abutments, and multi-unit components (straight/angled abutments, healing caps, temporary cylinders). Inputs: patient-specific dental implant interface; CAD/CAM digital design data. Transformation: pre-manufactured titanium alloy (Ti-6Al-4V ELI) interface connects to implant; custom superstructure milled at validated center. Output: prosthetic support for dental restorations. Used in dental clinics by clinicians. Output enables restoration of chewing function and soft tissue shaping. Benefits: provides patient-specific prosthetic rehabilitation compatible with various commercial implant systems.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including fatigue testing (ISO 14801:2016), biocompatibility testing (ISO 10993), and dimensional analysis/reverse engineering of implant-to-abutment interfaces.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI, ASTM F136) and Zirconia Oxide (InCoris Zi). Sensing/Actuation: Mechanical prosthetic support. Connectivity: Digital design data sent to validated milling centers. Sterilization: Non-sterile (requires sterilization). Design: Pre-milled blanks, Ti-base, and multi-unit abutments with engaging/non-engaging interfaces.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit prosthetic restorations (cemented, screw-retained, or overdenture) supported by compatible dental implants in the maxilla or mandible.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. ALLONUS Tech Co., LTD. Daniel Kwon Director 23-3, Sanmakgongdannam 4-gil Yangsan-si, 50568 REPUBLIC OF KOREA December 17, 2024 Re: K241616 Trade/Device Name: ALLONUS Tech Prosthetics Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 20, 2024 Received: November 20, 2024 Dear Daniel Kwon: 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 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) #### K241616 Device Name ALLONUS Tech Prosthetic Indications for Use (Describe) ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, or overdenture restorations. It is compatible with the following systems: - · Astra OsseoSpeed EV(K130999) 3.0 - · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm - · Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm - · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm - · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm - · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (6.0), 7.0 (6.8) mm (Mini, Regular) - · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1) - · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) - · Nobel Active 3.0 (K102436) 3.0 - · Nobel Active Internal Connection Implant (K071370) NP RP - · Nobelactive Wide Platform (Wp) (K133731) WP - Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB) - · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC) - Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC) - · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) - · (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7) All digitally designed abutments and or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture. Type of Use (Select one or both, as applicable) X 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 K241616 ## 1) Submitter | Submitter | ALLONUS Tech Co., Ltd. | | | | | |-----------------|-------------------------------------------------------------------|--|--|--|--| | | 23-3, Sanmakgongdannam 4-gil, Yangsan-si, Gyeongsangnam-do, Repub | | | | | | | lic of Korea | | | | | | Contact | Daniel Kwon | | | | | | Email | allonustech@gmail.com | | | | | | Phone | +1 949 232 7117 | | | | | | Date prepared : | 12/16/2024 | | | | | # 2) Device Information | Trade Name | ALLONUS Tech Prosthetic | |-----------------------|---------------------------------------| | Common Name | Endosseous dental implant abutment | | Classification Name | Abutment, Implant, Dental, Endosseous | | Regulation Number | 21 CFR 872.3630 | | Device Classification | Class II | | Product Code | NHA | ## 3) Predicate Device ## Primary Predicate: - K150203 Medentika CAD/CAM Abutment, Medentika GmbH ## Reference Devices: | K120414 | Astra OsseoSpeed EV by Astra Tech, Inc. | |---------|-------------------------------------------------------------------------------| | K093321 | BioHorizons Laser-Lok Implant System | | K071638 | Tapered Internal Implants | | K143022 | BioHorizons Tapered Internal Implants by BIOHORIZONS IMPLANT<br>SYSTEMS, INC. | {5}------------------------------------------------ - K113779 Conelog Screw-Line by CAMLOG Biotechnologies GmbH. K121995 OSSTEM TS Fixture System, OSSTEM Implant Co., Ltd. K182091 Osstem Abutment System, Osstem Implant Co., Ltd. K140091 Xpeed AnyRidge Internal Implant System, MegaGen Implant Co., Ltd. AnyRidge Internal Implant System, MegaGen Implant Co., Ltd. K110955 Neodent Implant System - GM Helix K163194 Neodent Implant System - GM Helix K180536 K102436 Nobel Active 3.0, Nobel Biocare AB 15 Esthetic Abutment NobelActive 03.0 1.5mm, 15 Esthetic Abutment NobelA K11581 ctive 03.0 3mm, 15 Esthetic Abutment NobelActive, Nobel Biocare AB K162890 BLT 02.9mm SC, SLA Or SLActive, RXD, Loxim, SC Closure Cap And Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment, Straumann USA, LLC K140878 Straumann® Bone Level Tapered Implants (NC, RC) K173961 Straumann BLX Implant (RB, WB) Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments K181703 by Institut Straumann AG K191256 Straumann BLX Ø3.5 mm Implants by Institut Straumann AG Zimmer 3.1mm Dental Implant;2.9mm Angled Abutment; Straight Hex, K142082 2.9mm Contour Abutment, Zimmer Dental Inc. K013227 Screw Vent® and Tapered Screw Vent K241485 TruAbutment DS, TruAbutment Inc. TiGEN Abutment, PMMA Abutment and Scan Healing Abutment, MegaGen K234142 Implant Co., Ltd. K072570 NOBELACTIVE MULTI UNIT ABUTMENT by NOBEL BIOCARE AB K171142 Healing Cap Multi-Unit Titanium by NOBEL BIOCARE AB K123988 ANYONETM INTERNAL IMPLANT SYSTEM by MEGAGEN IMPLANT CO., LTD {6}------------------------------------------------ ## 4) General Description #### Pre-Milled Blank ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) inte nded for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment. It has a pre-manufactured connection interface that fits directly to an endosseo us dental implant. The connection platform design includes both engaging and non-engag ing designs. Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface. All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture. Image /page/6/Figure/5 description: This image shows the pre-milled blank design limitations. There are two diagrams of dental implants with labels such as 'Max. Angulation', 'Gingival Height', 'Diameter', 'Total Length', 'Post Height', and 'Minimum Thickness'. There is a table that shows the design parameters for when machined at an angle of 0 degrees and when machined at any angle above 0 degrees. For example, the total length when machined at an angle of 0 degrees is 12mm, and when machined at any angle above 0 degrees is 11.077mm (Astra EV). Pre-Milled Blank Design Limitation: {7}------------------------------------------------ | | | 11.37 (BioHorizon) | |--------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------| | | | 11.191 (BLX) | | | | 11.225 (Bone Level) | | | | 11.228 (ConeLog) | | | | 11.247 (Osstem, Megagen) | | | | 11.002 (Neodent GM) | | | | 11.008 (NobelActive) | | | | 11.05 (Zimmer Eztetic) | | Minimum Gingival Height (mm) | 0.5 | 0.5 | | Maximum Gingival Height (mm) | 5.0 | 6.0 (Astra EV, BioHorizon, Conelog,<br>BLX, Bone Level, Osstem, Megagen,<br>NobelActive, Neodent GM, Zimmer<br>Eztetic) | | Minimum Wall Thickness (mm) | 0.4 | 0.3 (Astra EV)<br>0.37 (BLX)<br>0.4 (BioHorizon, Conelog, Bone<br>Level, Osstem, NobelActive, Neodent<br>GM)<br>0.5 (Megagen)<br>0.6 (Zimmer Eztetic) | | Minimum post height for single-unit<br>restorations (length above the<br>abutment collar / gingival height): | 4.0 | 4.0 (Astra EV, BioHorizon, Conelog,<br>BLX, Osstem, Megagen,<br>NobelActive, Neodent GM, Zimmer<br>Eztetic)<br>4.3 (Bone Level) | ## Ti-Base Abutment Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment. Ti Base is provided non-sterile therefore must be sterilized after the cementation of the patientspecified superstructure. Raw material blanks • InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. Cement · RelyX Unicem 2Automix by 3M ESPE, cleared under K100756. {8}------------------------------------------------ Design Limitation for Zirconia superstructure: Image /page/8/Figure/1 description: The image shows a diagram of a design limitation for Zirconia superstructure. The diagram includes measurements for the diameter, cuff height, post length, and thickness. A table below the diagram lists the design parameters and their limits, including a post angle of 0-15 degrees, gingival height of 0.5-5.0 mm, post height of 4.0-6.0 mm, diameter of 5.0-8.0 mm, and thickness of 0.4 mm. #### Multi-unit Abutment and Components Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multiunit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm. {9}------------------------------------------------ ## 5) Indications for Use ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations. It is compatible with the following systems: - · Astra OsseoSpeed EV(K130999) 3.0 - · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm - Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm - · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm - · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm - Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular) - · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1) - · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) - · Nobel Active 3.0 (K102436) 3.0 - · Nobel Active Internal Connection Implant (K071370) NP RP - · Nobelactive Wide Platform (Wp) (K133731) WP - Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB) - · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC) - · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC) - · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) - (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7) All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture. {10}------------------------------------------------ ## 6) Substantial Equivalence Comparison #### Pre-Milled Blank | Attributes | Subject Device | Primary Predicate Device | Reference Device | Reference Device | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Part Name | Pre-Milled Blank | Medentika Preface CAD/CAM Abutments | TiGEN Abutment; PMMA Abutment and<br>Scan Healing Abutment | TruAbutment DS | | 510(K) No. | K241616 | K150203 | K234142) | K241485 | | Applicant | ALLONUS Tech Co., Ltd. | Medentika GmbH | MegaGen Co., Ltd. | TruAbutment Inc | | Trade Name | ALLONUS Tech Prosthetic | Medentika CAD/CAM Abutment | TiGEN Abutment; PMMA Abutment and<br>Scan Healing Abutment | TruAbutment DS | | Classification<br>Name | Endosseous Dental Implant<br>Abutments (872.3630) | Endosseous Dental Implant Abutments<br>(872.3630) | Endosseous Dental Implant Abutments<br>(872.3630) | Endosseous Dental Implant Abutments<br>(872.3630) | | Product Code | NHA | NHA | NHA | NHA | | Material | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI<br>(ASTM F136) | Ti-6Al-4V ELI | Ti-6Al-4V ELI | | Surface<br>Treatment | None | None | None | None | | Indications For<br>Use/ Intended<br>Use | ALLONUS Tech Prosthetic is<br>intended for use with dental<br>implants as a support for single<br>or multiple-unit prosthetic<br>restorations in the maxilla or<br>mandible of partially or fully<br>edentulous patient. It is<br>including; cemented retained,<br>screw-retained, or overdenture<br>restorations.<br>It is compatible with the<br>following systems:<br>• Astra OsseoSpeed<br>EV(K130999) 3.0<br>• Astra OsseoSpeed<br>EV(K120414) 3.6, 4.2, 4.8, 5.4<br>mm<br>• Tapered Internal Implants<br>(K071638) (K143022) 3.4,<br>3.8, 4.6, 5.8 mm | Medentika Preface CAD/CAM Abutments<br>are intended for use with dental implants as<br>a support for single or multiple tooth<br>prostheses in the maxilla or mandible of a<br>partially or fully edentulous patient.<br>Implant<br>Implant<br>Platform Diameter<br>Series<br>System<br>Diameter<br>(mm)<br>Compatibility<br>(mm)<br>Nobel Biocare<br>3.5, 4.3, 5.0,<br>3.5, 4.3, 5.0, 6.0<br>Replace™<br>E<br>6.0<br>Select<br>Nobel Biocare<br>3.0, 3.5, 4.3,<br>3.0, 3.5, 3.9 (4.3),<br>F<br>NobelActive™<br>5.0<br>3.9 (5.0)<br>Biomet 3i<br>3.25, 4.0, 5.0<br>3.4, 4.1, 5.0<br>Osseotite®<br>H<br>Certain®<br>Biomet 3i<br>3.25, 3.75,<br>3.4, 4.1, 5.0<br>Osseotite®<br>I<br>4.0, 5.0<br>Nobel Biocare<br>3.3, 3.75, 4.0,<br>3.5, 4.1, 4.1, 5.1<br>K<br>Brånemark<br>5.0<br>Straumann<br>3.3, 4.1, 4.8<br>3.3, 4.1, 4.8<br>L<br>Bone Level | The TiGEN Abutment, PMMA Abutment<br>and Scan Healing Abutment are intended<br>for use on endosseous dental implants in<br>the edentulous or partially edentulous<br>maxilla or mandible, as an aid in<br>prosthetic rehabilitation.<br>The PMMA Abutment is indicated to be<br>used prior to the insertion of the final<br>components to maintain, stabilize and<br>shape<br>the soft tissue during the healing phase.<br>They must be placed out of occlusion and<br>are for temporary use (3 months).<br>For TiGEN Abutment and PMMA<br>Abutment, all digitally designed<br>abutments for use with PMMA Abutment<br>and TiGEN<br>Abutment are intended to be sent to a<br>MegaGen-validated milling center for<br>manufacture. | TruAbutment DS is a patient-specific CAD/CAM<br>abutment,<br>directly connected to endosseous dental implants and is<br>intended for use as an aid in prosthetic rehabilitation. It<br>is<br>compatible with the following systems:<br>Astra OsseoSpeed EV (K130999, K120414)<br>: 3.0, 3.6, 4.2, 4.8, 5.4 mm.<br>Biomet 3i Full OSSEOTITE Tapered Certain<br>(K130949)<br>: 3.25, 4.0, 5.0, 6.0 mm.<br>DIO UF(II) Internal Submerged (K161987, K170608,<br>K173975)<br>: 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow,<br>Regular)<br>mm.<br>Neoss ProActive® (K083561)<br>: 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.<br>Osstem TS (K161604)<br>: 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0),<br>7.0 (6.8)<br>(Mini, Regular) mm.<br>Camlog Screw-Line (K083496) | | Attributes | Subject Device | Primary Predicate Device | Reference Device | Reference Device | | Part Name | Pre-Milled Blank | Medentika Preface CAD/CAM Abutments | TiGEN Abutment; PMMA Abutment and<br>Scan Healing Abutment | TruAbutment DS | | | • BioHorizons Laser-Lok<br>Implant System (K093321)<br>3.0 mm<br>• Conelog Screw-Line<br>(K113779) 3.3, 3.8, 4.3, 5.0<br>mm<br>• Osstem TSIII SA (K121995)<br>3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) ,<br>5.0 (5.1), 6.0 (6.0), 7.0 (6.8)<br>mm (Mini, Regular)<br>• Megagen AnyRidge Internal<br>Implant System (K140091) 4.0,<br>4.4, 4.9, 5.4 (3.1)<br>• Neodent Implant System -<br>GM Helix (K163194, K180536)<br>3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0<br>(3.0)<br>• Nobel Active 3.0 (K102436)<br>3.0<br>• Nobel Active Internal<br>Connection Implant (K071370)<br>NP RP<br>• Nobelactive Wide Platform<br>(Wp) (K133731) WP<br>• Straumann BLX Implant<br>(K173961, K181703, K191256)<br>3.5, 3.75, 4.5, 5.5, 6.5 (RB,<br>WB)<br>• Straumann 02.9 mm Bone<br>Level Tapered Implants, SC<br>CARES Abutments (K162890)<br>2.9 (SC)<br>• Straumann® Bone Level<br>Tapered Implants (K140878)<br>3.3, 4.1, 4.8 (NC, RC) | Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5<br>Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1,<br>4.7, 6.0 3.5, 4.5, 5.7<br>Astra Tech OsseoSpeed™ S 3.0, 3.5, 4.0, 3.0, 3.5, 4.0, 4.5,<br>4.5, 5.0 5.0<br>Dentsply Friadent®<br>Frialit/XiVE® T 3.4, 3.8, 4.5,<br>5.5 3.4, 3.8, 4.5, 5.5<br>Medentika PreFace is intended for use with<br>the Straumann® CARES® System. All<br>digitally designed abutments for use with<br>Medentika CAD/CAM Abutments are<br>intended to be manufactured at a<br>Straumann® CARES® validated milling<br>center. | | : 3.3, 3.8, 4.3, 5.0, 6.0 mm.<br>Conelog Screw-Line (K113779)<br>: 3.3, 3.8, 4.3, 5.0 mm.<br>Implant Direct Legacy2 (K192221)<br>: 3.2 mm.<br>BioHorizons Internal (K093321, K071638, K143022)<br>: 3.0, 3.4, 3.8, 4.6, 5.8 mm.<br>MegaGen AnyRidge Internal Implant (K140091)<br>: 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm.<br>All digitally designed abutments and/or copings for use<br>with<br>the TruAbutment DS abutments are intended to be sent<br>to a<br>TruAbutment-validated milling center for manufacture.<br>TruAbutment DS is compatible with the following<br>devices:<br>Astra OsseoSpeed EV (K130999, K120414)<br>Implant Body Diameter (mm): 3.0 /Implant Platform<br>(mm):<br>3.0 / Internal Spline connection.<br>Implant Body Diameter (mm): 3.6 /Implant Platform<br>(mm):<br>3.6 / Internal Spline connection.<br>Implant Body Diameter (mm): 4.2 /Implant Platform<br>(mm):<br>4.2 / Internal Spline connection.<br>Implant Body Diameter (mm): 4.8 /Implant Platform<br>(mm):<br>4.8 / Internal Spline connection.<br>Implant Body Diameter (mm): 5.4 /Implant Platform<br>(mm):<br>5.4/ Internal Spline connection.<br>Biomet 3i Full OSSEOTITE Tapered Certain<br>(K130949)<br>Implant Body Diameter (mm): 3.25 / Implant Platform<br>(mm): 3.4 / Internal Hex connection.<br>Implant Body Diameter (mm): 4.0 / Implant Platform<br>(mm): 4.1 / Internal Hex connection.<br>Implant Body Diameter (mm): 5.0 / Implant Platform<br>(mm): 5.0 / Internal Hex connection.<br>Implant Body Diameter (mm): 6.0 / Implant Platform | | Attributes | Subject Device | Primary Predicate Device | Reference Device | Reference Device…
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