(195 days)
No
The summary describes a physical prosthetic device and its components, along with compatibility with various existing dental implant systems. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The design process is described as CAD/CAM, which is a standard digital design and manufacturing process, not inherently AI/ML.
Yes.
The device is intended for use with dental implants as a support for prosthetic restorations in the maxilla or mandible, which directly addresses a medical condition (edentulism) by replacing missing teeth.
No
Explanation: The device is described as a prosthetic intended for use with dental implants to support restorations. Its components (Pre-Milled Blank abutment, Ti-Base Abutment, Multi-unit Abutment) are structural elements for dental restoration, not tools for diagnosing a condition or disease.
No
The device description explicitly states that the device is made of titanium alloy and consists of physical components like Pre-Milled Blank abutments, Ti-Base Abutments, and Multi-unit Abutments and Components. It also mentions being sent to a milling center for manufacture, indicating a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient." This describes a device used in vivo (within the body) for structural support of dental prosthetics.
- Device Description: The device is described as being made of titanium alloy and consisting of components like abutments and cylinders. These are physical components designed to be implanted or attached to implants within a patient's mouth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of the ALLONUS Tech Prosthetic does not involve any such testing or analysis of biological samples.
Therefore, the ALLONUS Tech Prosthetic is a dental prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
NHA
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. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The connection platform design includes both engaging and non-engaging 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.
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 patient-specified 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was tested to evaluate its substantial equivalence according to the following standards:
- 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 worst-case scenario through fatigue testing.
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.
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 49.2 (2019): 783-795). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K120414, K093321, K071638, K143022, K113779, K121995, K182091, K140091, K110955, K163194, K180536, K102436, K11581, K162890, K140878, K173961, K181703, K191256, K142082, K013227, K241485, K234142, K072570, K171142, K123988
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
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)
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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 | ||||
| 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 |
| 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, |
| BLX, Bone Level, Osstem, Megagen, | ||
| NobelActive, Neodent GM, Zimmer | ||
| Eztetic) | ||
| Minimum Wall Thickness (mm) | 0.4 | 0.3 (Astra EV) |
| 0.37 (BLX) | ||
| 0.4 (BioHorizon, Conelog, Bone | ||
| Level, Osstem, NobelActive, Neodent | ||
| GM) | ||
| 0.5 (Megagen) | ||
| 0.6 (Zimmer Eztetic) | ||
| Minimum post height for single-unit | ||
| restorations (length above the | ||
| abutment collar / gingival height): | 4.0 | 4.0 (Astra EV, BioHorizon, Conelog, |
| BLX, Osstem, Megagen, | ||
| NobelActive, Neodent GM, Zimmer | ||
| Eztetic) | ||
| 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 | |
| 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 | |
| Scan Healing Abutment | TruAbutment DS | |||
| Classification | ||||
| Name | Endosseous Dental Implant | |||
| Abutments (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 | ||
| Surface | ||||
| Treatment | None | None | None | None |
| Indications For | ||||
| Use/ 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 | Medentika Preface CAD/CAM Abutments | |||
| are intended for use with dental implants as | ||||
| a support for single or multiple tooth | ||||
| prostheses in the maxilla or mandible of a | ||||
| partially or fully edentulous patient. | ||||
| Implant | ||||
| Implant | ||||
| Platform Diameter | ||||
| Series | ||||
| System | ||||
| Diameter | ||||
| (mm) | ||||
| Compatibility | ||||
| (mm) | ||||
| Nobel Biocare | ||||
| 3.5, 4.3, 5.0, | ||||
| 3.5, 4.3, 5.0, 6.0 | ||||
| Replace™ | ||||
| E | ||||
| 6.0 | ||||
| Select | ||||
| Nobel Biocare | ||||
| 3.0, 3.5, 4.3, | ||||
| 3.0, 3.5, 3.9 (4.3), | ||||
| F | ||||
| NobelActive™ | ||||
| 5.0 | ||||
| 3.9 (5.0) | ||||
| Biomet 3i | ||||
| 3.25, 4.0, 5.0 | ||||
| 3.4, 4.1, 5.0 | ||||
| Osseotite® | ||||
| H | ||||
| Certain® | ||||
| Biomet 3i | ||||
| 3.25, 3.75, | ||||
| 3.4, 4.1, 5.0 | ||||
| Osseotite® | ||||
| I | ||||
| 4.0, 5.0 | ||||
| Nobel Biocare | ||||
| 3.3, 3.75, 4.0, | ||||
| 3.5, 4.1, 4.1, 5.1 | ||||
| K | ||||
| Brånemark | ||||
| 5.0 | ||||
| Straumann | ||||
| 3.3, 4.1, 4.8 | ||||
| 3.3, 4.1, 4.8 | ||||
| L | ||||
| Bone Level | The TiGEN Abutment, PMMA Abutment | |||
| and Scan Healing Abutment are intended | ||||
| for use on endosseous dental implants in | ||||
| the edentulous or partially edentulous | ||||
| maxilla or mandible, as an aid in | ||||
| prosthetic rehabilitation. | ||||
| The PMMA Abutment is indicated to be | ||||
| used prior to the insertion of the final | ||||
| components to maintain, stabilize and | ||||
| shape | ||||
| the soft tissue during the healing phase. | ||||
| They must be placed out of occlusion and | ||||
| are for temporary use (3 months). | ||||
| For TiGEN Abutment and PMMA | ||||
| Abutment, all digitally designed | ||||
| abutments for use with PMMA Abutment | ||||
| and TiGEN | ||||
| Abutment are intended to be sent to a | ||||
| MegaGen-validated milling center for | ||||
| manufacture. | TruAbutment DS is a patient-specific CAD/CAM | |||
| abutment, | ||||
| directly connected to endosseous dental implants and is | ||||
| intended for use as an aid in prosthetic rehabilitation. It | ||||
| is | ||||
| compatible 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 and | |
| Scan Healing Abutment | TruAbutment DS | |||
| • 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) | Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5 | |||
| Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1, | ||||
| 4.7, 6.0 3.5, 4.5, 5.7 | ||||
| Astra Tech OsseoSpeed™ S 3.0, 3.5, 4.0, 3.0, 3.5, 4.0, 4.5, | ||||
| 4.5, 5.0 5.0 | ||||
| Dentsply Friadent® | ||||
| Frialit/XiVE® T 3.4, 3.8, 4.5, | ||||
| 5.5 3.4, 3.8, 4.5, 5.5 | ||||
| Medentika PreFace is intended for use with | ||||
| the Straumann® CARES® System. All | ||||
| digitally designed abutments for use with | ||||
| Medentika CAD/CAM Abutments are | ||||
| intended to be manufactured at a | ||||
| Straumann® CARES® validated milling | ||||
| center. | : 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 use | ||||
| with | ||||
| the TruAbutment DS abutments are intended to be sent | ||||
| to a | ||||
| TruAbutment-validated milling center for manufacture. | ||||
| TruAbutment DS is compatible with the following | ||||
| devices: | ||||
| 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 and | |
| Scan Healing Abutment | TruAbutment DS | |||
| • Zimmer 3.1mmD Dental | ||||
| Implant System (K142082) 3.1 | ||||
| (2.9) | (mm): 6.0 / Internal Hex connection. | |||
| DIO UF(II) Internal Submerged (K161987, K170608, | ||||
| K173975) | ||||
| 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. | 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 and | |
| Scan 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 and | |
| Scan 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 (°): | ||
| 0~25 | ||||
| Minimum and Maximum gingival (cuff) | ||||
| height (mm): 0.5~6.0 | ||||
| Minimum and Maximum diameter at | ||||
| abutment/implant | ||||
| interface (mm): 3.3~8.0 | ||||
| Minimum and Maximum length of abutment | ||||
| (mm): 6.0~11.0 | ||||
| Minimum wall thickness at the | ||||
| abutment/implant interface | ||||
| (mm): 0.4 | ||||
| Minimum and Maximum length of abutment | ||||
| post (length | ||||
| above 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 and | |
| Scan Healing Abutment | TruAbutment DS | |||
| Substatial | ||||
| Equivalence | The subject device, Pre-Milled Blank has similar indications for use and is made of the same material with no surface treatment, restoration, sterile compared | |||
| to that of the predicated Medentika Preface CAD/CAM Abutments. The design limits are slightly different. The design limits are slightly different. The | ||||
| subject device design limits are within the diameter range and angle range of the predicate device. Therefore, the Pre-Milled Blank and Medentika Preface | ||||
| CAD/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 | |||||||||||||||||||||||||||||||||||||||||||||
| Classification | |||||||||||||||||||||||||||||||||||||||||||||||
| Name | 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) | |||||||||||||||||||||||||||||||||||||||||||||||
| Surface | |||||||||||||||||||||||||||||||||||||||||||||||
| Treatment | None | None | |||||||||||||||||||||||||||||||||||||||||||||
| Indications For | |||||||||||||||||||||||||||||||||||||||||||||||
| Use/ 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) | Medentika TiBase CAD/CAM Abutments are | ||||||||||||||||||||||||||||||||||||||||||||||
| intended for use with dental implants as a | |||||||||||||||||||||||||||||||||||||||||||||||
| support for single or multiple tooth prostheses | |||||||||||||||||||||||||||||||||||||||||||||||
| in the maxilla or mandible of a partially or | |||||||||||||||||||||||||||||||||||||||||||||||
| fully edentulous patient. | |||||||||||||||||||||||||||||||||||||||||||||||
| Implant System | |||||||||||||||||||||||||||||||||||||||||||||||
| Compatibility Series Implant Diameter | |||||||||||||||||||||||||||||||||||||||||||||||
| (mm) Platform Diameter | |||||||||||||||||||||||||||||||||||||||||||||||
| (mm) Nobel Biocare | |||||||||||||||||||||||||||||||||||||||||||||||
| Replace™ | |||||||||||||||||||||||||||||||||||||||||||||||
| Select E 3.5, 4.3, 5.0, | |||||||||||||||||||||||||||||||||||||||||||||||
| 6.0 3.5, 4.3, 5.0, 6.0 Nobel Biocare | |||||||||||||||||||||||||||||||||||||||||||||||
| NobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3), 3.9 | |||||||||||||||||||||||||||||||||||||||||||||||
| (5.0) Biomet 3i | |||||||||||||||||||||||||||||||||||||||||||||||
| Osseotite® | |||||||||||||||||||||||||||||||||||||||||||||||
| Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 Biomet 3i | |||||||||||||||||||||||||||||||||||||||||||||||
| Osseotite® I 3.25, 3.75, | |||||||||||||||||||||||||||||||||||||||||||||||
| 4.0, 5.0 3.4, 4.1, 5.0 Nobel Biocare | |||||||||||||||||||||||||||||||||||||||||||||||
| Brånemark K 3.3, 3.75, 4.0, | |||||||||||||||||||||||||||||||||||||||||||||||
| 5.0 3.5, 4.1, 4.1, 5.1 Straumann | |||||||||||||||||||||||||||||||||||||||||||||||
| Bone Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 Straumann | |||||||||||||||||||||||||||||||||||||||||||||||
| Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5 Zimmer | |||||||||||||||||||||||||||||||||||||||||||||||
| Tapered | |||||||||||||||||||||||||||||||||||||||||||||||
| Screw-vent® R 3.3, 3.7, 4.1, | |||||||||||||||||||||||||||||||||||||||||||||||
| 4.7, 6.0 3.5, 4.5, 5.7 Astra Tech | |||||||||||||||||||||||||||||||||||||||||||||||
| OsseoSpeed™ S 3.5, 4.0, 4.5, | |||||||||||||||||||||||||||||||||||||||||||||||
| 5.0 3.5, 4.0, 4.5, 5.0 Dentsply | |||||||||||||||||||||||||||||||||||||||||||||||
| Friadent® | |||||||||||||||||||||||||||||||||||||||||||||||
| Frialit/XiVE® T 3.4, 3.8, 4.5, | |||||||||||||||||||||||||||||||||||||||||||||||
| 5.5 3.4, 3.8, 4.5, 5.5 Dentsply | |||||||||||||||||||||||||||||||||||||||||||||||
| Friadent® | |||||||||||||||||||||||||||||||||||||||||||||||
| 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 the | |||||||||||||||||||||||||||||||||||||||||||||||
| Straumann® CARES® System. All digitally | |||||||||||||||||||||||||||||||||||||||||||||||
| designed abutments for use with Medentika | |||||||||||||||||||||||||||||||||||||||||||||||
| CAD/CAM Abutments are intended to be | |||||||||||||||||||||||||||||||||||||||||||||||
| manufactured at a Straumann® CARES® | |||||||||||||||||||||||||||||||||||||||||||||||
| validated milling center. |
17
| 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 coping | ||
| for use with the abutments are intended to be | ||
| sent to a ALLONUS Tech-validated milling | ||
| center for manufacture. | ||
| Prosthesis | ||
| Attachment | 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
6.08.0
-Diameter (Ø, mm): 5.0
-Thickness (mm): 0.4 | - Post Angle (°): 0307.0 |
-Diameter (Ø, mm): 3.0
| Sterile | Non-sterile | Non-sterile |
| Substatial
Equivalence | The Subject device, Ti Base has similar indications for use, design limits and is made of the
same material with no surface treatment, restoration, sterile compared to that of the predicated
Medentika TiBase CAD/CAM Abutments. The design limits are slightly different. The subject
device design limits are within the diameter range and angle range of the predicate device. And
that doesn't affect to intended use or function. Therefore, the Ti Base and Medentika TiBase
CAD/CAM Abutments are substantially equivalent devices. | |
Multi-Unit Abutment
| Attributes | Subject Device | Reference Device |
|---|---|---|
| Part Name | Multi-unit Straight Abutment | |
| Multi-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 |
| Classification | ||
| Name | Endosseous Dental Implant | |
| Abutments(872.3630) | Endosseous Dental Implant | |
| Abutments(872.3630) | ||
| Product Code | NHA | NHA |
| Material | Ti-6Al-4V ELI (ASTM F136) | Titanium vanadium alloy |
| Indications For | ||
| Use/ 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 | NobelActive Multi Unit Abutment is a pre- | |
| manufactured prosthetic component directly | ||
| connected to the endosseous dental implant | ||
| and is intended for use as an aid in prosthetic | ||
| rehabilitation. | ||
| Attributes | Subject Device | Reference Device |
| Part Name | Multi-unit Straight Abutment | |
| Multi-unit Angled Abutment | Nobel Active Multi Unit Abutment | |
| 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) | ||
| 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. | ||
| Diameter(mm) | 4.8 | 4.8 |
| Gingival | ||
| Height(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 Abutment | |
| Multi-unit Angled Abutment | Nobel Active Multi Unit Abutment | |
| Substatial | ||
| Equivalence | The subject device, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment has similar | |
| indications for use and is made of same titanium alloy with no surface treatment, is supplied | ||
| non-sterile compared to that of Nobel Active Multi Unit Abutment. The subject device's | ||
| diameter is slightly big, gingival height is slightly different, angles are within the predicate | ||
| device's range. And that doesn't affect to intended use or function. Therefore, the Multi-Unit | ||
| Straight Abutment, Multi-Unit Angled Abutment, and Nobel Active Multi Unit Abutment are | ||
| substantially equivalent devices. |
18
19
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 |
| Classification | ||
| Name | Endosseous Dental Implant | |
| Abutments(872.3630) | Endosseous Dental Implant | |
| Abutments(872.3630) | ||
| Product Code | NHA | NHA |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Indications For | ||
| Use/ 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) | The Healing Cap Multi-unit Titanium is a | |
| premanufactured prosthetic component to be | ||
| directly connected to the dental abutment | ||
| during soft tissue healing to protect the internal | ||
| connection of the abutments and prepare the | ||
| soft tissue for the prosthetic procedure. | ||
| Maximum intra-oral use is 180-days. |
20
| 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 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) | ||
| 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. | ||
| Diameter(mm) | 5.1 | 4.8 |
| Length(mm) | 12 | 12 |
| Substantial | ||
| Equivalence | The subject device, Multi-Unit Healing Cap has similar indications for use, same length, and is | |
| made of the same material, is supplied non-sterile compared to that of Healing Cap Multi-unit | ||
| Titanium. The subject device's diameter is slightly big, and that doesn't affect to intended use or | ||
| function. Therefore, the Multi-Unit Healing Cap and Healing Cap Multi-unit Titanium are | ||
| substantially 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 |
| Classification | ||
| Name | Endosseous Dental Implant | |
| Abutments(872.3630) | Endosseous Dental Implant | |
| Abutments(872.3630) | ||
| Product Code | NHA | NHA |
| Material | Ti-6A1-4V ELI (ASTM F136) | Ti-6A1-4V ELI (ASTM F136) |
| Indications For | ||
| Use/ Intended | ||
| Use | ALLONUS Tech Prosthetic is intended for | |
| use with dental implants as a support for | ||
| single or multiple-unit prosthetic restorations | The AnyOne™ Internal Implant System is | |
| intended to be surgically placed in the | ||
| maxillary or mandibular molar areas for the | ||
| purpose providing prosthetic support for | ||
| Attributes | Subject Device | Reference Device |
| Part Name | Multi-Unit Temporary Cylinder | |
| 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) | ||
| Temporary Cylinder | ||
| dental restorations (Crown, bridges, and | ||
| overdentures) in partially or fully edentulous | ||
| individuals. It is used to restore a patient's | ||
| chewing function. | ||
| Smaller implants (less than 06.0 mm) are | ||
| dedicated for immediate loading when good | ||
| primary stability is achieved and with | ||
| appropriate occlusal loading. Larger implants | ||
| are dedicated for the molar region and are | ||
| indicated for delayed loading. | ||
| Diameter(mm) | 5.0 | 4.8 |
| Length(mm) | 12 | - |
| Substantial | ||
| Equivalence | The subject device, Multi-Unit Temporary Cylinder has similar indications for use, diameter | |
| and 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 are | ||
| substantially equivalent devices. |
21
22
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 |
| Classification | ||
| Name | Endosseous Dental Implant | |
| Abutments(872.3630) | Endosseous Dental Implant | |
| Abutments(872.3630) | ||
| Product Code | NHA | NHA |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Surface | ||
| Treatment | None | None |
| Indications For | ||
| Use/ 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 | The AnyOne™ Internal Implant System is | |
| intended to be surgically placed in the | ||
| maxillary or mandibular molar areas for the | ||
| purpose providing prosthetic support for | ||
| dental restorations (Crown, bridges, and | ||
| overdentures) in partially or fully edentulous | ||
| individuals. It is used to restore a patient's | ||
| chewing function. | ||
| Smaller implants (less than 06.0 mm) are | ||
| dedicated for immediate loading when good | ||
| primary stability is achieved and with | ||
| appropriate occlusal loading. Larger implants | ||
| are dedicated for the molar region and are | ||
| indicated 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 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) | ||
| 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. | ||
| Diameter(mm) | 5.2 | 5.0 |
| Substantial | ||
| Equivalence | The subject device, Multi-Unit Cylinder has similar indications for use, diameter and is made | |
| of the same material, is supplied non-sterile compared to that of EZ Post Cylinder. The subject | ||
| device'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. |
23
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.
24
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.