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 Description

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

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 (Multi-unit 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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

Feature/Test	Acceptance Criteria (Based on Predicate/Standards)	Reported Device Performance (Subject Device)
Materials	Ti-6Al-4V ELI (ASTM F136) for metallic components, Zirconia Oxide for Ti-Base superstructure	Ti-6Al-4V ELI (ASTM F136) for Pre-Milled Blank, Multi-Unit Abutment, Healing Cap, Temporary Cylinder, Ti-Cylinder. Ti-6Al-4V ELI (ASTM F136) and Zirconia Oxide (InCoris Zi) for Ti Base.
Fatigue Test (ISO 14801:2016)	Met criteria of the standard.	Met criteria of the standard. (Page 23)
End-User Steam Sterilization (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010)	Met criteria of the standard.	Met criteria of the standard. (Page 23)
Biocompatibility (ISO 10993-1:2009, -5:2009, -10:2010)	Met criteria of the standard.	Met criteria of the standard. (Page 23)
Implant-to-Abutment Compatibility	Demonstrated by reverse engineering and assessment of OEM components.	Demonstrated compatibility with various OEM implant systems (listed in Indications for Use). Reverse engineering included assessment of maximum and minimum dimensions of critical design aspects and tolerances of OEM implant body, OEM abutment, OEM abutment screw, along with cross-sectional images of the subject device and compatible implant body. (Page 24)
MR Safety (FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment")	Demonstrated substantial equivalence to predicate devices using scientific rationale and published literature for magnetically induced displacement force and torque.	Non-clinical worst-case MRI review performed; rationale addressed parameters per FDA guidance. Results demonstrated substantial equivalence to predicate devices. (Page 24)
Design Limits (examples)	Pre-Milled Blank: Post Angle: 0-30°, Diameter: 3.0-7.0 mm (Predicate) Ti Base: Post Angle: 0-30°, Diameter: 3.0-7.0 mm (Predicate) Multi-Unit Abutment: Diameter: 4.8 mm, Gingival Height: 1.5-4.5 mm, Angle: 0, 17, 30° (Reference Device)	Pre-Milled Blank: Design limits are "slightly different" but within diameter and angle range of predicate. (Page 11) Specific limits are provided in a table on page 7 for various compatible systems (e.g., Min Gingival Height: 0.5 mm, Max Gingival Height: 5.0-6.0 mm, Min Wall Thickness: 0.3-0.6 mm, Min Post Height: 4.0-4.3 mm). Ti Base: Post Angle: 0-15°, Gingival Height: 0.5-5.0 mm, Post Height: 4.0-6.0 mm, Diameter: 5.0-8.0 mm, Thickness: 0.4 mm. These are "slightly different" but within diameter and angle range of predicate. (Page 17) Multi-Unit Abutment: Diameter: 4.8 mm, Gingival Height: 1, 2, 3, 4, 5, 6 mm, Angle: 0, 17, 29°. Diameter is "slightly big," gingival height "slightly different," angles "within the predicate device's range." (Page 18)
Sterility	Non-sterile (Predicate)	Non-sterile (All subject devices)
Indications for Use / Intended Use	Similar to predicate devices	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 patients, including cemented-retained, screw-retained, or overdenture restorations. Compatible with various specific implant systems. (Pages 3, 9, 10, 16, 17, 18, 19, 20, 21, 22)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test Set Sample Size:
- The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
Data Provenance:
- The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
- The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for a physical medical device.

Summary

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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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about 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

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Indications for Use

510(k) Number (if known)

K241616

Device Name

ALLONUS Tech Prosthetic

Indications for Use (Describe)

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)

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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 IMPLANTSYSTEMS, INC.

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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

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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:

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		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,BLX, Bone Level, Osstem, Megagen,NobelActive, Neodent GM, ZimmerEztetic)
Minimum Wall Thickness (mm)	0.4	0.3 (Astra EV)0.37 (BLX)0.4 (BioHorizon, Conelog, BoneLevel, Osstem, NobelActive, NeodentGM)0.5 (Megagen)0.6 (Zimmer Eztetic)
Minimum post height for single-unitrestorations (length above theabutment collar / gingival height):	4.0	4.0 (Astra EV, BioHorizon, Conelog,BLX, Osstem, Megagen,NobelActive, Neodent GM, ZimmerEztetic)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.

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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.

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5) Indications for Use

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.

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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 andScan 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 andScan Healing Abutment	TruAbutment DS
ClassificationName	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental Implant Abutments(872.3630)	Endosseous Dental Implant Abutments(872.3630)	Endosseous Dental Implant Abutments(872.3630)
Product Code	NHA	NHA	NHA	NHA
Material	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI	Ti-6Al-4V ELI
SurfaceTreatment	None	None	None	None
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic isintended for use with dentalimplants as a support for singleor multiple-unit prostheticrestorations in the maxilla ormandible of partially or fullyedentulous patient. It isincluding; cemented retained,screw-retained, or overdenturerestorations.It is compatible with thefollowing systems:• Astra OsseoSpeedEV(K130999) 3.0• Astra OsseoSpeedEV(K120414) 3.6, 4.2, 4.8, 5.4mm• Tapered Internal Implants(K071638) (K143022) 3.4,3.8, 4.6, 5.8 mm	Medentika Preface CAD/CAM Abutmentsare intended for use with dental implants asa support for single or multiple toothprostheses in the maxilla or mandible of apartially or fully edentulous patient.ImplantImplantPlatform DiameterSeriesSystemDiameter(mm)Compatibility(mm)Nobel Biocare3.5, 4.3, 5.0,3.5, 4.3, 5.0, 6.0Replace™E6.0SelectNobel Biocare3.0, 3.5, 4.3,3.0, 3.5, 3.9 (4.3),FNobelActive™5.03.9 (5.0)Biomet 3i3.25, 4.0, 5.03.4, 4.1, 5.0Osseotite®HCertain®Biomet 3i3.25, 3.75,3.4, 4.1, 5.0Osseotite®I4.0, 5.0Nobel Biocare3.3, 3.75, 4.0,3.5, 4.1, 4.1, 5.1KBrånemark5.0Straumann3.3, 4.1, 4.83.3, 4.1, 4.8LBone Level	The TiGEN Abutment, PMMA Abutmentand Scan Healing Abutment are intendedfor use on endosseous dental implants inthe edentulous or partially edentulousmaxilla or mandible, as an aid inprosthetic rehabilitation.The PMMA Abutment is indicated to beused prior to the insertion of the finalcomponents to maintain, stabilize andshapethe soft tissue during the healing phase.They must be placed out of occlusion andare for temporary use (3 months).For TiGEN Abutment and PMMAAbutment, all digitally designedabutments for use with PMMA Abutmentand TiGENAbutment are intended to be sent to aMegaGen-validated milling center formanufacture.	TruAbutment DS is a patient-specific CAD/CAMabutment,directly connected to endosseous dental implants and isintended for use as an aid in prosthetic rehabilitation. Itiscompatible with the following systems:Astra OsseoSpeed EV (K130999, K120414): 3.0, 3.6, 4.2, 4.8, 5.4 mm.Biomet 3i Full OSSEOTITE Tapered Certain(K130949): 3.25, 4.0, 5.0, 6.0 mm.DIO UF(II) Internal Submerged (K161987, K170608,K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow,Regular)mm.Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.Osstem TS (K161604): 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0),7.0 (6.8)(Mini, Regular) mm.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 andScan Healing Abutment	TruAbutment DS
	• BioHorizons Laser-LokImplant System (K093321)3.0 mm• Conelog Screw-Line(K113779) 3.3, 3.8, 4.3, 5.0mm• 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 InternalImplant 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 InternalConnection 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 BoneLevel Tapered Implants, SCCARES Abutments (K162890)2.9 (SC)• Straumann® Bone LevelTapered Implants (K140878)3.3, 4.1, 4.8 (NC, RC)	Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1,4.7, 6.0 3.5, 4.5, 5.7Astra Tech OsseoSpeed™ S 3.0, 3.5, 4.0, 3.0, 3.5, 4.0, 4.5,4.5, 5.0 5.0Dentsply Friadent®Frialit/XiVE® T 3.4, 3.8, 4.5,5.5 3.4, 3.8, 4.5, 5.5Medentika PreFace is intended for use withthe Straumann® CARES® System. Alldigitally designed abutments for use withMedentika CAD/CAM Abutments areintended to be manufactured at aStraumann® CARES® validated millingcenter.		: 3.3, 3.8, 4.3, 5.0, 6.0 mm.Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm.Implant Direct Legacy2 (K192221): 3.2 mm.BioHorizons Internal (K093321, K071638, K143022): 3.0, 3.4, 3.8, 4.6, 5.8 mm.MegaGen AnyRidge Internal Implant (K140091): 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm.All digitally designed abutments and/or copings for usewiththe TruAbutment DS abutments are intended to be sentto aTruAbutment-validated milling center for manufacture.TruAbutment DS is compatible with the followingdevices:Astra OsseoSpeed EV (K130999, K120414)Implant Body Diameter (mm): 3.0 /Implant Platform(mm):3.0 / Internal Spline connection.Implant Body Diameter (mm): 3.6 /Implant Platform(mm):3.6 / Internal Spline connection.Implant Body Diameter (mm): 4.2 /Implant Platform(mm):4.2 / Internal Spline connection.Implant Body Diameter (mm): 4.8 /Implant Platform(mm):4.8 / Internal Spline connection.Implant Body Diameter (mm): 5.4 /Implant Platform(mm):5.4/ Internal Spline connection.Biomet 3i Full OSSEOTITE Tapered Certain(K130949)Implant Body Diameter (mm): 3.25 / Implant Platform(mm): 3.4 / Internal Hex connection.Implant Body Diameter (mm): 4.0 / Implant Platform(mm): 4.1 / Internal Hex connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): 5.0 / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform
Attributes	Subject Device	Primary Predicate Device	Reference Device	Reference Device
Part Name	Pre-Milled Blank	Medentika Preface CAD/CAM Abutments	TiGEN Abutment; PMMA Abutment andScan Healing Abutment	TruAbutment DS
	• Zimmer 3.1mmD DentalImplant System (K142082) 3.1(2.9)			(mm): 6.0 / Internal Hex connection.DIO UF(II) Internal Submerged (K161987, K170608,K173975)
	All digitally designed abutmentsand/or coping for use with theabutments are intended to besent to a ALLONUS Tech-validated milling center formanufacture.			Implant Body Diameter (mm): 3.3 /Implant Platform(mm):Narrow / Internal Hex connection.
				Implant Body Diameter (mm): 3.8 /Implant Platform(mm):Regular / Internal Hex connection.
				Implant Body Diameter (mm): 4.0 /Implant Platform(mm):Regular / Internal Hex connection.
				Implant Body Diameter (mm): 4.5 /Implant Platform(mm):Regular / Internal Hex connection.
				Implant Body Diameter (mm): 5.0 /Implant Platform(mm):Regular / Internal Hex connection.
				Implant Body Diameter (mm): 5.5 /Implant Platform(mm):Regular / Internal Hex connection.
				Implant Body Diameter (mm): 6.0 /Implant Platform(mm):Wide / Internal Hex connection.
				Implant Body Diameter (mm): 6.5 /Implant Platform(mm):Wide / Internal Hex connection.
				Implant Body Diameter (mm): 7.0 /Implant Platform(mm):Wide / Internal Hex connection.
				Neoss ProActive® (K083561)Implant Body Diameter (mm): 3.25 / Implant Platform(mm): 3.5 / Internal Hex connection.
				Implant Body Diameter (mm): 3.5 /Implant Platform(mm):4.0 / Internal Hex connection.
				Implant Body Diameter (mm): 4.0 /Implant Platform(mm):4.0 / Internal Hex connection.
				Implant Body Diameter (mm): 4.5 /Implant Platform(mm):4.0 / Internal Hex connection.
Attributes	Subject Device	Primary Predicate Device	Reference Device	Reference Device
Part Name	Pre-Milled Blank	Medentika Preface CAD/CAM Abutments	TiGEN Abutment; PMMA Abutment andScan Healing Abutment	TruAbutment DS
				4.0 / Internal Hex connection.Implant Body Diameter (mm): 5.0 /Implant Platform(mm):
				4.0 / Internal Hex connection.Implant Body Diameter (mm): 5.5 /Implant Platform(mm):
				4.0 / Internal Hex connection.Implant Body Diameter (mm): 6.0 /Implant Platform(mm)
				4.0 / Internal Hex connection.Osstem TS (K161604)Implant Body Diameter (mm): 3.0 / Implant Platform(mm):
				2.1 / Internal Hex connection.Implant Body Diameter (mm): 3.5 / Implant Platform(mm):
				2.1 / Internal Hex connection.Implant Body Diameter (mm): 4.0 / Implant Platform(mm):
				2.5/ Internal Hex connection.Implant Body Diameter (mm): 4.5 / Implant Platform(mm):
				2.5 / Internal Hex connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm):
				2.5 / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform(mm):
				2.5 / Internal Hex connection.Implant Body Diameter (mm): 7.0 / Implant Platform(mm):
				2.5 / Internal Hex connection.Camlog Screw-Line (K083496)Implant Body Diameter (mm): 3.3 / Implant Platform(mm):
				3.3 / Tube-in-tube connection.Implant Body Diameter (mm): 3.8 /Implant Platform(mm):
				3.8 / Tube-in-tube connection.Implant Body Diameter (mm): 4.3 /Implant Platform(mm):
				4.3 / Tube-in-tube connection.
Attributes	Subject Device	Primary Predicate Device	Reference Device	Reference Device
Part Name	Pre-Milled Blank	Medentika Preface CAD/CAM Abutments	TiGEN Abutment; PMMA Abutment andScan Healing Abutment	TruAbutment DS
				Implant Body Diameter (mm): 5.0 /Implant Platform(mm):5.0 / Tube-in-tube connection.Implant Body Diameter (mm): 6.0 /Implant Platform(mm):6.0/ Tube-in-tube connection.Conelog Screw-Line (K113779)Implant Body Diameter (mm): 3.3 /Implant Platform(mm):3.3 / Conical abutment connection.Implant Body Diameter (mm): 3.8 /Implant Platform(mm):3.8 / Conical abutment connection.Implant Body Diameter (mm): 4.3 /Implant Platform(mm):4.3 / Conical abutment connection.Implant Body Diameter (mm): 5.0 /Implant Platform(mm):5.0 / Conical abutment connection.
Restoration	Single-unit, Multi-unit	Single-unit, Multi-unit	Single-unit	Single-unit, Multi-unit
Design Limits(Min.~Max.)	Image: Design Parameters	- Post Angle (°): 0~~30-Diameter (Ø, mm): 3.0~~7.0	Image: Minimum and Maximum	Minimum and Maximum abutment angle (°):0~~25Minimum and Maximum gingival (cuff)height (mm): 0.5~~6.0Minimum and Maximum diameter atabutment/implantinterface (mm): 3.3~~8.0Minimum and Maximum length of abutment(mm): 6.0~~11.0Minimum wall thickness at theabutment/implant interface(mm): 0.4Minimum and Maximum length of abutmentpost (lengthabove the abutment collar/gingival height)(mm): 4.0~7.0
Sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Attributes	Subject Device	Primary Predicate Device	Reference Device	Reference Device
Part Name	Pre-Milled Blank	Medentika Preface CAD/CAM Abutments	TiGEN Abutment; PMMA Abutment andScan Healing Abutment	TruAbutment DS
SubstatialEquivalence	The subject device, Pre-Milled Blank has similar indications for use and is made of the same material with no surface treatment, restoration, sterile comparedto that of the predicated Medentika Preface CAD/CAM Abutments. The design limits are slightly different. The design limits are slightly different. Thesubject device design limits are within the diameter range and angle range of the predicate device. Therefore, the Pre-Milled Blank and Medentika PrefaceCAD/CAM Abutments are substantially equivalent devices.The maximum gingival height of TruAbutment DS of K241485 was 6. The minimum thickness of the Megagen TiGEN Abutment in K234142 was 0.3.

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Ti Base

Attributes	Subject Device	Primary Predicate Device
Part Name	Ti Base	Medentika TiBase CAD/CAM Abutments
510(K) No.	K241616	K150203
Applicant	ALLONUS Tech Co., Ltd.	Medentika GmbH
Trade Name	ALLONUS Tech Prosthetic	Medentika CAD/CAM Abutment
ClassificationName	Endosseous Dental Implant Abutments(872.3630)	Endosseous Dental Implant Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)Zirconia Oxide	Ti-6Al-4V ELI(ASTM F136)
SurfaceTreatment	None	None
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic is intended for usewith dental implants as a support for single ormultiple-unit prosthetic restorations in themaxilla or mandible of partially or fullyedentulous patient. It is including; cementedretained, screw-retained, or overdenturerestorations.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 ImplantSystem (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 TaperedImplants, SC CARES Abutments (K162890)2.9 (SC)	Medentika TiBase CAD/CAM Abutments areintended for use with dental implants as asupport for single or multiple tooth prosthesesin the maxilla or mandible of a partially orfully edentulous patient.
	Implant SystemCompatibility Series Implant Diameter(mm) Platform Diameter(mm) Nobel BiocareReplace™Select E 3.5, 4.3, 5.0,6.0 3.5, 4.3, 5.0, 6.0 Nobel BiocareNobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3), 3.9(5.0) Biomet 3iOsseotite®Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3iOsseotite® I 3.25, 3.75,4.0, 5.0 3.4, 4.1, 5.0 Nobel BiocareBrånemark K 3.3, 3.75, 4.0,5.0 3.5, 4.1, 4.1, 5.1 StraumannBone Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 StraumannStandard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5 ZimmerTaperedScrew-vent® R 3.3, 3.7, 4.1,4.7, 6.0 3.5, 4.5, 5.7 Astra TechOsseoSpeed™ S 3.5, 4.0, 4.5,5.0 3.5, 4.0, 4.5, 5.0 DentsplyFriadent®Frialit/XiVE® T 3.4, 3.8, 4.5,5.5 3.4, 3.8, 4.5, 5.5 DentsplyFriadent®Ankylos® Y 3.5, 4.5, 5.5,7.0 3.5, 4.5, 5.5, 7.0
		Medentika TiBase is intended for use with theStraumann® CARES® System. All digitallydesigned abutments for use with MedentikaCAD/CAM Abutments are intended to bemanufactured at a Straumann® CARES®validated milling center.

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Attributes	Subject Device	Primary Predicate Device
Part Name	Ti Base	Medentika TiBase CAD/CAM Abutments
	• 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)• 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 copingfor use with the abutments are intended to besent to a ALLONUS Tech-validated milling
	center for manufacture.
ProsthesisAttachment	Cement-retained, Screw-retained	Cement-retained, Screw-retained
Restoration	Single-unit, Multi-unit	Single-unit, Multi-unit
Design Limits(Min.~Max.)	- Post Angle (°): 0~~15- Gingival Height (mm): 0.5~~5.0- Post Height (mm): 4.0~~6.0-Diameter (Ø, mm): 5.0~~8.0-Thickness (mm): 0.4	- Post Angle (°): 0~~30-Diameter (Ø, mm): 3.0~~7.0
Sterile	Non-sterile	Non-sterile
SubstatialEquivalence	The Subject device, Ti Base has similar indications for use, design limits and is made of thesame material with no surface treatment, restoration, sterile compared to that of the predicatedMedentika TiBase CAD/CAM Abutments. The design limits are slightly different. The subjectdevice design limits are within the diameter range and angle range of the predicate device. Andthat doesn't affect to intended use or function. Therefore, the Ti Base and Medentika TiBaseCAD/CAM Abutments are substantially equivalent devices.

Multi-Unit Abutment

Attributes	Subject Device	Reference Device
Part Name	Multi-unit Straight AbutmentMulti-unit Angled Abutment	Nobel Active Multi Unit Abutment
510(K) No.	K241616	K072570
Applicant	ALLONUS Tech Co., Ltd.	Nobel Biocare AB
Trade Name	ALLONUS Tech Prosthetic	NobelActive Multi Unit Abutment
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Titanium vanadium alloy
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic is intended foruse with dental implants as a support forsingle or multiple-unit prosthetic restorationsin the maxilla or mandible of partially or fullyedentulous patient. It is including; cemented	NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implantand is intended for use as an aid in prostheticrehabilitation.
Attributes	Subject Device	Reference Device
Part Name	Multi-unit Straight AbutmentMulti-unit Angled Abutment	Nobel Active Multi Unit Abutment
	retained, screw-retained, or overdenturerestorations.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 ImplantSystem (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 TaperedImplants, 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)All digitally designed abutments and/orcoping for use with the abutments areintended to be sent to a ALLONUS Tech-validated milling center for manufacture.
Diameter(mm)	4.8	4.8
GingivalHeight(mm)	1, 2, 3, 4, 5, 6	1.5, 2.5, 3.5, 4.5
Angle(°)	0, 17, 29	0, 17, 30
Sterile	Non-sterile	Non-sterile
Attributes	Subject Device	Reference Device
Part Name	Multi-unit Straight AbutmentMulti-unit Angled Abutment	Nobel Active Multi Unit Abutment
SubstatialEquivalence	The subject device, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment has similarindications for use and is made of same titanium alloy with no surface treatment, is suppliednon-sterile compared to that of Nobel Active Multi Unit Abutment. The subject device'sdiameter is slightly big, gingival height is slightly different, angles are within the predicatedevice's range. And that doesn't affect to intended use or function. Therefore, the Multi-UnitStraight Abutment, Multi-Unit Angled Abutment, and Nobel Active Multi Unit Abutment aresubstantially equivalent devices.

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Multi-Unit Healing Cap

Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Healing Cap	Healing Cap Multi-unit Titanium
510(K) No.	K241616	K171142
Applicant	ALLONUS Tech Co., Ltd.	Nobel Biocare AB
Trade Name	ALLONUS Tech Prosthetic	Healing Cap Multi-Unit Titanium
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic is intended for usewith dental implants as a support for single ormultiple-unit prosthetic restorations in themaxilla or mandible of partially or fullyedentulous patient. It is including; cementedretained, screw-retained, or overdenturerestorations.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)	The Healing Cap Multi-unit Titanium is apremanufactured prosthetic component to bedirectly connected to the dental abutmentduring soft tissue healing to protect the internalconnection of the abutments and prepare thesoft tissue for the prosthetic procedure.Maximum intra-oral use is 180-days.

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Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Healing Cap	Healing Cap Multi-unit Titanium
	• 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 TaperedImplants, 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)All digitally designed abutments and/or copingfor use with the abutments are intended to besent to a ALLONUS Tech-validated millingcenter for manufacture.
Diameter(mm)	5.1	4.8
Length(mm)	12	12
SubstantialEquivalence	The subject device, Multi-Unit Healing Cap has similar indications for use, same length, and ismade of the same material, is supplied non-sterile compared to that of Healing Cap Multi-unitTitanium. The subject device's diameter is slightly big, and that doesn't affect to intended use orfunction. Therefore, the Multi-Unit Healing Cap and Healing Cap Multi-unit Titanium aresubstantially equivalent devices.

Multi-Unit Temporary Cylinder

Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Temporary Cylinder	Temporary Cylinder
510(K) No.	K241616	K123988
Applicant	ALLONUS Tech Co., Ltd.	MegaGen Implant Co., Ltd.
Trade Name	ALLONUS Tech Prosthetic	Anyone™ Internal Implant System
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6A1-4V ELI (ASTM F136)	Ti-6A1-4V ELI (ASTM F136)
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic is intended foruse with dental implants as a support forsingle or multiple-unit prosthetic restorations	The AnyOne™ Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support for
Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Temporary Cylinderin the maxilla or mandible of partially or fullyedentulous patient. It is including; cementedretained, screw-retained, or overdenturerestorations.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 ImplantSystem (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)	Temporary Cylinderdental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function.Smaller implants (less than 06.0 mm) arededicated for immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Larger implantsare dedicated for the molar region and areindicated for delayed loading.
Diameter(mm)	5.0	4.8
Length(mm)	12	-
SubstantialEquivalence	The subject device, Multi-Unit Temporary Cylinder has similar indications for use, diameterand is made of the same material, is supplied non-sterile compared to that of Temporary	Cylinder. The subject device's diameter is slightly big, and that doesn't affect to intended use or
Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Temporary Cylinder	Temporary Cylinder
	function. Therefore, the Multi-Unit Temporary Cylinder and Temporary Cylinder aresubstantially equivalent devices.

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Multi-Unit Ti-Cylinder

Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Ti-Cylinder	EZ Post Cylinder
510(K) No.	K241616	K123988
Applicant	ALLONUS Tech Co., Ltd.	MegaGen Implant Co., Ltd.
Trade Name	ALLONUS Tech Prosthetic	Anyone™ Internal Implant System
ClassificationName	Endosseous Dental ImplantAbutments(872.3630)	Endosseous Dental ImplantAbutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
SurfaceTreatment	None	None
Indications ForUse/ IntendedUse	ALLONUS Tech Prosthetic is intended foruse with dental implants as a support forsingle or multiple-unit prosthetic restorationsin the maxilla or mandible of partially or fullyedentulous patient. It is including; cementedretained, screw-retained, or overdenturerestorations.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 ImplantSystem (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	The AnyOne™ Internal Implant System isintended to be surgically placed in themaxillary or mandibular molar areas for thepurpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals. It is used to restore a patient'schewing function.Smaller implants (less than 06.0 mm) arededicated for immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Larger implantsare dedicated for the molar region and areindicated for delayed loading.
Attributes	Subject Device	Reference Device
Part Name	Multi-Unit Ti-Cylinder	EZ Post Cylinder
	• Straumann BLX Implant (K173961,K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5(RB, WB)• Straumann 02.9 mm Bone Level TaperedImplants, 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)All digitally designed abutments and/orcoping for use with the abutments areintended to be sent to a ALLONUS Tech-validated milling center for manufacture.
Diameter(mm)	5.2	5.0
SubstantialEquivalence	The subject device, Multi-Unit Cylinder has similar indications for use, diameter and is madeof the same material, is supplied non-sterile compared to that of EZ Post Cylinder. The subjectdevice's diameter is slightly big, and that doesn't affect to intended use or function. Therefore,the Multi-Unit Cylinder and EZ Post Cylinder are substantially equivalent devices.

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7) Performance Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

The tests below were performed for the subject device:

· Fatigue Test according to ISO 14801:2016
· End-User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
· Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and it consisted of testing finished assembled implant/abutment systems of the worstcase

scenario through fatigue testing.

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Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, using the OEM implant body, OEM abutment, OEM abutment screw. The reverse

engineering included an assessment of maximum and minimum dimensions of critical design aspects and tolerances of the OEM implant body, OEM abutment, OEM abutment screw, along with cross-sectional images of the submission device and compatible implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with reference devices.

Clinical testing was not necessary to establish substantial equivalency of the proposed device.

8) MR safety environment

'Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795). Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices.'

9) Conclusion

The documentation submitted in this 510(k) demonstrates the ALLONUS Tech Prosthetic is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)