(296 days)
The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:
Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)
This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|---|
| Indications for Use | Identical or equivalent to predicate devices. | The subject device's indications for use are "substantially equivalent" to predicate devices, addressing prosthetic support for dental restorations in partially or fully edentulous individuals. Minor wording differences are considered acceptable and not affecting substantial equivalence. |
| Technical Characteristics | Similar design, material, sizing, connection interface, sterilization method, and principle of operation to predicate devices, or minor differences not affecting safety and effectiveness. | Multi-unit Abutment: Largely identical to predicate and reference devices in most characteristics, with minor differences in total length and gingival height falling within combined ranges or being considered negligible. Surface treatment (Anodizing vs. Machined) changed for some, but shown not to affect substantial equivalence.Multi-unit Angled Abutment: Similar to predicate and reference devices. Minor differences in diameter, length, post height, gingival height, and angulation are within combined ranges or considered negligible. Connection interface differences (Hex/Octa vs. Octa only) covered by reference devices. Surface treatment (Anodizing vs. Machined) addressed by other predicate/reference devices. Multi-unit Abutment Screw, Abutment Screw, Multi Post Screw, Healing Cap, Temporary Cylinder, CCM Cylinder, Cylinder Screw: Similar in most characteristics to predicate/reference devices, with minor dimensional differences (diameter, length, post height, gingival height) falling within combined ranges or being deemed minor and not affecting substantial equivalence. |
| Biocompatibility | Meets ISO 10993-1 requirements. | Evaluation performed according to ISO 10993-1. No additional testing required as material composition, manufacturing process, and patient-contacting parts are identical to cleared predicate devices (AnyOne Internal Implant System K123988 and AnyRidge Octa 1 Implant System K182448). |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6 post-user sterilization. | Non-sterile device supplied to user. Sterilization validation testing for steam sterilization performed according to ISO 11137 and ISO 17665-1, 2 to verify SAL of 10^-6. |
| Performance (Physical Properties) | Meets performance criteria defined by ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment." | Bench tests performed, and results "met the pre-set criteria." The Multi-unit Angled Abutment (worst-case) was specifically tested for fatigue. Fatigue testing not considered for straight abutments as per guidance. |
| Modified Surface Treatment | Evaluation performed in accordance with "Section 11 of Class II Special Controls Guidance Document". | Multi-unit Abutment, Multi-unit Angled Abutment described as having same surface treatment (Anodizing) and manufacturing process as K123988 and K182448. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.
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 concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2021
MegaGen Implant Co. Ltd. % You Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K203808
Trade/Device Name: Multi-unit Abutment, Multi-unit Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2021 Received: September 22, 2021
Dear You Kim:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Andrew 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203808
Device Name
Multi-unit Abutment, Multi-unit Angled Abutment
Indications for Use (Describe)
The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for K203808
Date: October 19, 2021
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Tel: +82-53-247-2258 Fax: +82-53-247-2254 Email: ra3@dgri.co.kr
3. Device
- Multi-unit Abutment, Multi-unit Angled Abutment Trade Name:
- Endosseous Dental Implant Abutment Common Name:
- . Classification Name: Endosseous dental implant abutment
- Classification Product Code: NHA
- . Classification regulation: Class II, 21 CFR 872.3630
4. Predicate Device
- . Primary Predicate Device: K182448 – AnyRidge Octa 1 Implant System
. Reference Devices:
- K123988 AnyOne Internal Implant System K192401 - Straumann® Screw-Retained Abutments K201621 – Magicore II System K141457 – Dentium Implantium® and SuperLine® Abutments K110955 - AnyRidge Internal Implant System K171142 - Healing Cap Multi-Unit Titanium K052369 - ExFeel Dental Implant System
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5. Description
The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.
The Multi-unit Abutment, Multi-unit Angled Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible ImplantSystem | Device Name | 510(k)Number | Connection | Diameter (mm) |
|---|---|---|---|---|---|
| MegaGenImplant Co.,Ltd. | Xpeed AnyRidgeInternal ImplantSystem | XpeedAnyRidgeInternal Fixture | K123870K140091 | InternalHex | 4.0, 4.4, 4.9, 5.4,5.9, 6.4, 6.9, 7.4,7.9, 8.4 |
| AnyOneInternal ImplantSystem | AnyOneInternal Fixture | K123988 | InternalHex | 3.9, 4.3, 4.8, 5.3,5.8, 6.3, 6.8, 7.3,7.8, 8.3 | |
| AnyRidge Octa 1Implant System | AnyRidge Octa1 Fixture | K182448 | InternalOcta | 3.6, 3.7, 4.0, 4.1,4.4, 4.8, 5.0, 5.5 |
The Multi-unit Abutment, Multi-unit Angled Abutment is consisted of the following devices.
| Device | Content | ||
|---|---|---|---|
| 1. | Abutment | Multi-unit Abutment | Description The Multi-unit Abutment is used for fabricating screw-retained prosthesis. There are two types of Multi-unit Abutments, N type and S type, depending on the connection type and prosthetics compatibility. The N type (one-piece type) is screwed directly in to the endosseous dental implant by their lower threaded part, and the S type (two-piece type) is connected the fixture with Multi-unit Abutment Screw. |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension (Diameter & Total Length) | $\varnothing$ 4.8 x 8.05, 8.75, 8.94, 9.10, 9.75, 9.80, 9.84, 10.75, 10.80, 10.84, 11.75, 11.80, 11.84, 12.80, 12.84mm$\varnothing$ 5.0 x 6.2, 7.2, 8.2, 9.2, 10.2 mm | ||
| Post Heights | 1.8, 2.2 mm | ||
| Gingival Heights | 0.6, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 mm | ||
| Angulation | Straight | ||
| Compatible Implant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| Multi-unit Angled Abutment | Description The Multi-unit Angled Abutment is used for fabricating screw-retained prosthesis and correcting the prosthetic angulation of implant. There are two types of Multi-unit Angled Abutments, N type and S type, depending on the prosthetics compatibility. The N type (two-piece type) is connected the fixture with Multi-unit Abutment Screw, and the S type (two-piece type) is connected the fixture with Abutment Screw or Multi Post Screw. | ||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension (Diameter & Length) | $\varnothing$ 4.8 x 3.4, 3.9, 3.94, 4.35, 4.4, 4.9, 4.94, 5.35, 5.4, 5.85, 5.9, 5.94, 6.35, 6.4, 6.85, 6.9, 6.94, 7.35, 7.85, 8.85 mm$\varnothing$ 5.0 x 4.5, 4.7, 5.5, 5.6, 5.7, 5.8, 6.5, 6.6, 6.7, 6.8, 7.5, 7.6, 7.7, | ||
| 7.8, 8.6, 8.8 mm | |||
| Post Heights | 2.2, 3.9 mm | ||
| Gingival Heights | 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, mm | ||
| Angulation | 17°, 29°, 30° | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| Multi-unitAbutmentScrew | Description | The Multi-unit Abutment Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to the Fixture. | |
| Used with | Multi-unit Abutment (S type) in Xpeed AnyRidge & AnyOneMulti-unit Angled Abutment (N type) in Xpeed AnyRidge & AnyOne& AnyRidge Octa 1 | ||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter &Total Length) | Ø 2.1 x 7.0 mmØ 2.2 x 4.4 mmØ 2.4 x 6.8 mmØ 2.95 x 10.8, 11.5, 11.8, 12.5, 12.8, 13.5, 13.8, 14.5, 15.5 mm | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| AbutmentScrew | Description | The Abutment Screw is used for connecting Multi-unit Angled Abutment to the Fixture. | |
| Used with | Multi-unit Angled Abutment (S type) in AnyOne | ||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter &Total Length) | Ø 2.3 x 7.7 mm | ||
| CompatibleImplant System | AnyOne Internal Implant System | ||
| Multi PostScrew | Description | The Multi Post Screw is used for connecting Multi-unit Angled Abutment to the Fixture. | |
| Used with | Multi-unit Angled Abutment (S type) in Xpeed AnyRidge | ||
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter &Total Length) | Ø 2.1 x 7.0 mm | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant System | ||
| 2. Components | Healing Cap | Description | The Healing Cap is used for protecting Multi-unit (Angled) Abutment and minimizing irritation to tongue and oral mucosa during period of gingival healing.It is connected to the Abutment using Cylinder Screw. |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 4.9 x 4.20 mmØ 6.8 x 4.20 mm | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| TemporaryCylinder | Description | The Temporary Cylinder is used in conjunction with Multi-unit (Angled) Abutment to provide support for provisional restoration. It is connected to the Abutment using Cylinder Screw. | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | Ø 4.8 x 12.0 mm | ||
| Cuff Heights | 3.0 mm | ||
| Angulation | Straight | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| CCMCylinder | Description | The CCM Cylinder is used in conjunction with Multi-unit(Angled) Abutment to provide support for screw type finalprosthesis by casting with non-precious metal alloy (Co-Cr-MoAlloy). It is connected to the Abutment using Cylinder Screw. | |
| Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | ||
| Dimension(Diameter & Length) | $Ø$ 4.8 x 13.0, 15.0 mm | ||
| Post Height | 10.0, 13.0 mm | ||
| Cuff Heights | 2.0, 3.0 mm | ||
| Angulation | Straight | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System | ||
| CylinderScrew | Description | The Cylinder Screw is used for connecting Multi-unit (Angled)Abutment to Healing Cap, Temporary cylinder or CCM Cylinder. | |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | ||
| Dimension(Diameter & Length) | $Ø$ 2.0 x 3.4 mm | ||
| CompatibleImplant System | Xpeed AnyRidge Internal Implant SystemAnyOne Internal Implant SystemAnyRidge Octa 1 Implant System |
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[Note 1] Some of devices described in this submission, Multi-unit Abutment and Multi-unit Abutment screw in AnyOne Internal Implant System had been FDA cleared with K123988, but it is being submitted to change their identifier without any modifications, and to add a new model.
[Note 2] Some of devices described in this submission, Multi-unit Abutment, Multi-unit Angled Abutment and Multi-unit Abutment screw in AnyRidge Octa 1 Implant System had been FDA cleared with K182448, but it is being submitted to change their identifier with modification of surface treatment (Machined →Anodizing), and to add a new model. The changes are explained not affecting substantial equivalence in the part of 'VII. Substantial Equivalence Comparison'.
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6. Indication for use
The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
7. Basis for Substantial Equivalence
The Multi-unit Abutment, Multi-unit Angled Abutment is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size range of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.
The subject device is composed of the abutments and prosthetic components that are used for single & multiple unit screw retained restorations, while the predicate devices is addressed complete dental implant system including various fixtures and abutments.
For this reason, the indication for use statement appear to be different between subject and predicate devices but proposed indication is available to apply to predicate devices as well, since the submission device is a sub-set of devices included in the predicate devices.
Also, the point of those indications is ultimately identical in the way that all of devices in subject & predicate devices are intended to be provided the prosthetic support for dental restorations such as crown, bridges, and overdenture to restore patient's chewing function; and this is minor difference in wording not affecting the substantial equivalence of the subject device.
Therefore, the indication for use of subject device is substantially equivalent to the predicate devices.
The Indications for the subject device are identical except for the portion of K182448's indications that are specific to dental implant bodies, and this submission does not include any dental implant bodies, so the omission of this statement is acceptable.
In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out the physical property. The test result supports the substantial equivalence to the predicate device.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate devices.
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Multi-unit Abutment
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 | K192401 | |
| Device Name | Multi-unit AbutmentFor Multi-unit Abutment,Multi-unit AngledAbutment | Multi-unit AbutmentFor AnyRidge Octa 1 ImplantSystem | Multi-unit AbutmentFor AnyOne Internal ImplantSystem | Straumann® Screw-Retained Abutments | |
| Manufacturer | MegaGen Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | Straumann USA, LLC | |
| Indicationsfor UseStatement | The Multi-unit Abutment,Multi-unit AngledAbutment is intended tobe surgically placed in themaxillary or mandibulararches for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. | The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary ormandibular arches for thepurpose of providingprosthetic support fordental restorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function in thefollowing situations andwith the clinical protocols:-Delayed loading.-Immediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion. | The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than 6.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicatedfor delayed loading. | Prosthetic componentsdirectly or indirectlyconnected to theendosseous dental implantare intended for use as anaid in prostheticrehabilitations. Temporarycomponents can be usedprior to the insertion of thefinal components tomaintain, stabilize andshape the soft tissueduring the healing phase;they are to be placed outof occlusion. Finalabutments may be placedinto occlusion for implantswith sufficient primarystability or for implantsthat are fullyosseointegrated.Temporary Abutmentshave a maximum durationof usage of 180 days. | |
| Design | Image: Multi-unit Abutment | Image: Multi-unit Abutment | Image: Multi-unit Abutment | Image: Screw-Retained Abutments | |
| Diameter (Ø) | 4.8, 5.0 mm | 4.8 mm | 5.0 mm | 3.5, 4.6 mm | |
| Total Length | 6.2, 7.2, 8.05, 8.2,8.75, 8.94, 9.1, 9.2,9.75, 9.8, 9.84, 10.2,10.75, 10.8, 10.84,11.75, 11.8, 11.84, 12.8,12.84 mm | 9.8, 10.8, 11.8, 12.8mm | 6.2, 7.2, 8.2, 9.2, 10.2mm | Not Known | |
| Post Height | 1.8, 2.2 mm | 2.2 mm | 1.8 mm | Not Known | |
| GingivalHeight | 0.6, 1.5, 2.0, 2.5, 3.0,3.5, 4.0, 4.5, 5.0, 5.5mm | 1.3, 2.3, 3.3, 4.3 mm | 1.5, 2.5, 3.5, 4.5, 5.5mm | 1.5, 2.5, 3.5, 4.5 and5.5 mm | |
| Angulation | Straight | Straight | Straight | Straight | |
| ConnectionInterface | Internal Hex,Internal Non-Hex,Internal ConicalConnection | Internal ConicalConnection | Internal Hex,Internal Non-Hex | CrossFit® (NC and RC)(with conical fitting) | |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-7Nb | |
| SurfaceTreatment | Anodizing | Anodizing, Machined | Anodizing | Anodizing | |
| Single Use | Yes | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Gamma Irradiation | |
| RestorationType | Single & Multi | Single & Multi | Single & Multi | Single & Multi | |
| Principle ofOperation | This product is a pre-manufacturedprosthetic componentdirectly or indirectlyconnected to theendosseous dentalimplant using itsthreaded part or screwfor aid in prostheticrehabilitation. | This product is a pre-manufacturedprosthetic componentdirectly connected tothe endosseous dentalimplant using itsthreaded part for aid inprostheticrehabilitation. | This product is a pre-manufacturedprosthetic componentconnected to theendosseous dentalimplant using the screwfor aid in prostheticrehabilitation. | This product is a pre-manufacturedprosthetic componentdirectly connected tothe endosseous dentalimplant using itsthreaded part for aid inprostheticrehabilitation. | |
| CompatibleImplantSystem | Xpeed AnyRidgeInternal Implant SystemAnyOne InternalImplant SystemAnyRidge Octa 1Implant System | AnyRidge Octa 1Implant System | AnyOne InternalImplant System | Straumann® BoneLevel Implants | |
| Substantial Equivalence Discussion | |||||
| Subject Device | Predicate Device | Reference Device1 | Reference Device2 | Reference Device3 | |
| 510(k) No. | K203808 | K182448 | K192401 | K201621 | K141457 |
| Device Name | Multi-unit AngledAbutmentFor Multi-unitAbutment, Multi-unitAngled Abutment | Multi-unit AngledAbutmentFor AnyRidge Octa 1Implant System | Straumann®Screw-RetainedAbutments | Magic MultiunitAbutmentFor Magicore IISystem | Angled ScrewAbutmentDentiumImplantium® andSuperLine®Abutments |
| Manufacturer | MegaGen ImplantCo., Ltd. | MegaGen ImplantCo., Ltd. | Straumann USA,LLC | InnoBioSurg Co.,Ltd. | Dentium Co., Ltd. |
| Indicationsfor UseStatement | The Multi-unitAbutment, Multi-unitAngled Abutment isintended to besurgically placed inthe maxillary ormandibular archesfor the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. | The AnyRidge Octa 1Implant System isintended to besurgically placed inthe maxillary ormandibular archesfor the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulousindividuals. It is usedto restore a patient'schewing function inthe followingsituations and withthe clinical protocols:-Delayed loading.-Immediate loadingwhen goodprimary stability isachieved and withappropriate occlusalloading. Largerimplants arededicated for themolar region. | Prostheticcomponents directlyor indirectlyconnected to theendosseous dentalimplant are intendedfor use as an aid inprostheticrehabilitations.Temporarycomponents can beused prior to theinsertion of the finalcomponents tomaintain, stabilizeand shape the softtissue during thehealing phase; theyare to be placed outof occlusion. Finalabutments may beplaced into occlusionfor implants withsufficient primarystability or forimplants that arefullyosseointegrated.TemporaryAbutments have amaximum durationof usage of 180 days. | The Magicore IISystem is intended toreplace missing teethto restore chewingfunction. TheMagicore IISystem can be placedin support of singleor multiple-unitrestorationsincluding; cementretained, screwretained, oroverdenturerestorations, andterminal orimmediate abutmentsupport for fixedbridgework.This system is for oneor two stage surgicalprocedures. Thissystem is intendedfor delayed loading. | Dentium Prostheticsare intended for useas an aid inprostheticrehabilitation. |
| Design | Image: Multi-unit Angled Abutment | Image: Multi-unit Angled Abutment | Image: Straumann Screw-Retained Abutments | Image: Magic Multiunit Abutment | Image: Angled Screw Abutment |
| Diameter (Ø) | 4.8, 5.0 mm | 4.8 mm | 3.5, 4.6 mm | 4.8, 5.8 mm | 4.5 to 5.5 mm |
| Length | 3.4, 3.9, 3.94,4.35, 4.4, 4.5, 4.7,4.9, 4.94, 5.35, 5.4,5.5, 5.6, 5.7, 5.8,5.85, 5.9, 5.94,6.35, 6.4, 6.5, 6.6,6.7, 6.8, 6.85, 6.9,6.94,7.35, 7.5, 7.6, 7.7,7.8, 7.85, 8.6, 8.8,8.85 mm | 5.35, 6.35, 6.85,7.35, 7.85,8.85mm | Not Known | 3.9 ~ 8.5 mm | Not Known |
| Post Height | 2.2, 3.9 mm | 2.2 mm | Not Known | Not Known | Not Known |
| GingivalHeight | 1.0, 1.5, 2.0, 2.5,3.0, 3.5, 4.0, 4.5,mm | 2.3, 3.3, 4.3mm | 1.5, 2.5, 3.5, 4.5and 5.5 mm | 1.5, 2.5, 3.5, 4.5mm | 1.0 to 1.5 mm |
| Angulation | 17°, 29°, 30° | 17°, 30° | 1.5, 2.5, 3.5, 4.5and 5.5 mm | 5°, 10°, 20° | 15° to 30° |
| ConnectionInterface | Internal Hex,Internal Non-Hex,Internal Octa,Internal Non-Octa | Internal Octa,Internal Non-Octa | CrossFit® (NC andRC) (with conicalfitting) | Internal Hex,Internal Non-Hex | Internal Hex,Internal Non-Hex |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-7Nb | Ti-6Al-4V ELI(ASTM F136-13) | Pure Ti-G4(ASTM F67) |
| SurfaceTreatment | Anodizing | Machined | Anodizing | Machined | Tin Coated |
| Single Use | Yes | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | GammaIrradiation | Non-sterile | Non-sterile |
| RestorationType | Single & Multi | Single & Multi | Single & Multi | Single & Multi | Not Known |
| Principle ofOperation | This product is apre-manufacturedprostheticcomponentconnected to theendosseous dentalimplant using thescrew and isintended for use asan aid in prostheticrehabilitation. | This product is apre-manufacturedprostheticcomponentconnected to theendosseous dentalimplant using thescrew and isintended for use asan aid in prostheticrehabilitation. | This product is apre-manufacturedprostheticcomponentconnected to theendosseous dentalimplant using thescrew and isintended for use asan aid in prostheticrehabilitation. | This product is apre-manufacturedprostheticcomponentconnected to theendosseous dentalimplant using thescrew and isintended for use asan aid in prostheticrehabilitation. | This product is apre-manufacturedprostheticcomponentconnected to theendosseous dentalimplant using thescrew and isintended for use asan aid in prostheticrehabilitation. |
| CompatibleImplantSystem | Xpeed AnyRidgeInternal ImplantSystemAnyOne InternalImplant SystemAnyRidge Octa 1Implant System | AnyRidge Octa 1Implant System | Straumann® BoneLevel Implants | Magicore IISystem | DentiumImplantium andSuperLine |
| Substantial Equivalence Discussion |
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Similarities 1.
The subject device has the same characteristic for the followings compared to the predicate device 1.
Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Surface Treatment, ı Single Use, Sterilization, Restoration type and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device & reference device 1.
- ၊ Total Length, Gingival Height
Almost all the lengths of subject device lie within combined range of predicate & reference devices. The only difference is that slight longer length(12.84mm) is added in the subject device but it is a very slight difference(0.04mm) between the longest length(12.8mm) of predicate device. The Gingival Height of subject device is slightly different with predicate device, but it does not cause a matter in substantial equivalence since these size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
Some of subject device had been FDA cleared with K123988 and K182448, but this submission is being submitted ı to change their identifier with modification of surface treatment only for K182448 (Machined→Anodizing), and to
add new models in the compatible implant system. Therefore, the proposed Multi-unit Abutment and predicate devices have common in Indication for use, Design, Diameter, Post Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization type and Principle of Operation. The differences are explained not affecting on the substantial equivalence. Also, the fatigue testing is not considered since the proposed device is a straight type without angulation.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
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Multi-unit Angled Abutment
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1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
Indication for use, Design, Material, Single Use, Sterilization, Restoration type and Principle of Operation । Differences
The subject device has the different characteristic for the followings compared to the predicate devices.
-
Diameter ।
The subject device has same diameter as predicate device 2 for diameter 4.8mm. The only difference is that slight larger diameter(5.0mm) is added in the subject device. However, it lies within combined range of predicate & reference devices. -
-Length, Post Height,
Almost all the lengths of subject device lie within combined range of predicate & reference devices. The only difference is that slight shorter length(3.4mm) is added in the subject device but it is a very slight difference. The subject device has same post height as predicate device for height 2.2mm. The only difference is that slight longer height(3.9mm) is added in the subject device. However, it does not cause a matter in substantial equivalence since these size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. -
-Gingival Height
The Gingival Height of subject device is slightly different with predicate device, but all the gingival heights of subject device lie within combined range of predicate & reference devices. -
ー Angulation
The subject device has same angulation as predicate device 1 for angle 17° and 30°. The only difference is that slight smaller angle (29°) is added in the subject device but it lies within range of predicate & reference devices and it is a very slight difference (1°) between the biggest angle (30°) of predicate device. -
l Connection Interface
The subject device has Hex & Octa connection while the predicate device has Octa connection only. However, the connection difference can be covered by the reference devices. Also, both feature of Hex and Octa provides antirotational feature. -
-Surface Treatment The subject device has surface treatment of Anodizing while the predicate device has machined surface, but the multiple predicate & reference devices for Anodizing are presented in the other component comparison charts.
-
- Discussion
Some of subject device had been FDA cleared with K182448, but this submitted to change their ।
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identifier with modification of surface treatment only, and to add new models in the compatible implant system. Therefore, the proposed Multi-unit Angled Abutment and predicate device have common in Indication for use, Design, Material, Single Use, Sterilization, Restoration type and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
Also, the fatigue test was performed on the subject and predicate device to confirm the substantial equivalence. The subject device (Multi-unit Angled Abutment) has been selected as the representative specimen in this submission under the consideration of worst case in accordance with 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports that the subject device is substantially equivalent to the predicate device and the difference is not affecting the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
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Multi-unit Abutment Screw
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Multi-unit Abutment ScrewFor Multi-unit Abutment, Multi-unitAngled Abutment | Multi-unit Abutment ScrewFor AnyRidge Octa 1 Implant System | Multi-unit Abutment ScrewFor AnyOne Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. | The AnyRidge Octa 1 ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular arches for the purposeof providing prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. It isused to restore a patient's chewingfunction in the following situationsand with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The AnyOne Internal ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading. |
| Design | |||
| Diameter (Ø) | 2.1, 2.2, 2.4, 2.95 mm | 2.1 mm | 2.95 mm |
| Total Length | 4.4, 6.8, 7.0, 10.8, 11.5, 11.8,12.5, 12.8, 13.5, 13.8, 14.5, 15.5mm | 7.0 mm | 11.5, 12.5, 13.5, 14.5, 15.5mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) |
| SurfaceTreatment | Machined, Anodizing | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | Multi-unit Abutment Screw isused for connecting Multi-unitAbutment or Multi-unit AngledAbutment to the fixture. | Multi-unit Abutment Screw isused for connecting Multi-unitAbutment or Multi-unit AngledAbutment to the fixture. | Multi-unit Abutment Screw isused for connecting Multi-unitAbutment to the fixture. |
| CompatibleImplant System | Xpeed AnyRidge InternalImplant SystemAnyOne Internal ImplantSystem | AnyRidge Octa1 InternalImplant System | AnyOne Internal ImplantSystem |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the predicate device & referenceDevice.- Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation | |||
| 2. DifferencesThe subject device has the different characteristic for the followings compared to the predicate device & referenceDevice.- Diameter, Total LengthThe Diameter of subject device is slightly different with predicate device but all the diameters of subject device liewithin combined range of predicate device & reference devices.The length of subject device is slightly different with predicate device but it does not cause a matter in substantialequivalence since the difference is very minor, and the variety of the size can be possible to operate more precisetreatment to meet each patient's condition.- Surface Treatment | |||
| The other difference is in surface treatment but the anodizing method is for improving the visibility and multiple |
predicate/reference devices for anodizing are already presented in the other component comparison charts.
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3. Discussion
- । Some of subject device had been FDA cleared with K123988 and K182448, but this submission is being submitted to change their identifier without any modifications, and to add new models in the compatible implant system. Therefore, the proposed Multi-unit Abutment Screw and predicate device have common in Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation. The differences are explained not affecting on the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
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Abutment Screw
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Abutment ScrewFor Multi-unit Abutment, Multi-unitAngled Abutment | Abutment ScrewFor AnyRidge Octa 1 Implant System | Abutment ScrewFor AnyOne Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. | The AnyRidge Octa 1 ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular arches for the purposeof providing prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. It isused to restore a patient's chewingfunction in the following situationsand with the clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region. | The AnyOne Internal ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading. |
| Design | Image: Subject Device Design | Image: Predicate Device Design | Image: Reference Device Design |
| Diameter (Ø) | 2.3 mm | 2.2 mm | 2.3 mm |
| Total Length | 7.7 mm | 7.9 mm | 10.1 mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | Abutment screw is used for isused for connecting Multi-unitAngled Abutment to the fixture. | Abutment screw is used for isused for connecting theAbutment to the fixture. | Abutment screw is used for isused for connecting theAbutment to the fixture. |
| CompatibleImplant System | AnyOne Internal ImplantSystem | AnyRidge Octa1 InternalImplant System | AnyOne Internal ImplantSystem |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device & reference Device.
ı Indication for use, Design, Diameter, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
Differences 2.
The subject device has the different characteristic for the followings compared to the predicate device & reference Device.
- Total Length
The length of subject device is slightly shorter than predicate device but it does not cause a matter in substantial equivalence since the difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
The proposed Abutment Screw is being submitted to add in Megagen's existing prosthetic portfolio which had ı been FDA cleared. Therefore, the proposed Abutment Screw and predicate device have common in Indication for use, Design, Diameter, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The size difference is explained not affecting on the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
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Multi Post Screw
| Subject Device | Reference Device | |
|---|---|---|
| 510(k) No. | K203808 | K110955 |
| Device Name | Multi Post Screw | Multi Post Screw |
| For Multi-unit Abutment, Multi-unit Angled Abutment | For AnyRidge Internal Implant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUseStatement | The Multi-unit Abutment, Multi-unit Angled Abutment isintended to be surgically placed in the maxillary ormandibular arches for the purpose providing prostheticsupport for dental restorations (Crown, bridges, andoverdentures) in partially or fully edentulous individuals. | The AnyRidge Internal Implant System is intendedto be surgically placed in the maxillary ormandibular molar areas for the purpose providingprosthetic support for dental restorations (Crown,bridges, and overdentures) in partially or fullyedentulous individuals. It is used to restore apatient's chewing function. Smaller implants (lessthan o6.0 mm) are dedicated for immediateloading when good primary stability is achievedand with appropriate occlusal loading. Largerimplants are dedicated for the molar region andare indicated for delayed loading. |
| Design | Image: Multi Post Screw | Image: Multi Post Screw |
| Diameter (Ø) | 2.1 mm | 2.1 mm |
| Total Length | 7.0 mm | 8.0 mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection |
| Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Material | (ASTM F136-13) | (ASTM F136-13) |
| SurfaceTreatment | Anodizing | Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle ofOperation | Multi Post Screw is used for connecting Multi-unitAngled Abutment to the Fixture. | Multi Post Screw is used for connecting theAbutment to the Fixture. |
| CompatibleImplantSystem | Xpeed AnyRidge Internal Implant System | AnyRidge Internal Implant System |
| Substantial Equivalence Discussion |
1. Similarities
- The subject device has the same characteristic for the followings compared to the reference device.
- ı Indication for use, Design, Diameter, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device.
- ı Total Length
The length of subject device is slightly shorter than reference device but it does not cause a matter in substantial equivalence since the difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
- The proposed Multi Post Screw is being submitted to add in Megagen's existing prosthetic portfolio which had ı been FDA cleared. Therefore, the proposed Multi Post Screw and reference device have common in Indication for use, Design, Diameter, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The size difference is explained not affecting on the substantial equivalence. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference device.
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Healing Cap
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203808 | K123988 | K171142 |
| DeviceName | Healing CapFor Multi-unit Abutment, Multi-unitAngled Abutment | Healing CapFor AnyOne Internal Implant System | Healing Cap Multi-UnitTitaniumFor Nobel Biocare Multi UnitAbutments |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Nobel Biocare USA LLC |
| Indications forUseStatement | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially orfully edentulous individuals. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. | The Healing Cap Multi-unit Titaniumis a premanufactured prostheticcomponent to be directly connectedto the dental abutment during softtissue healing to protect the internalconnection of the abutments andprepare the soft tissue for theprosthetic procedure.Maximum intra-oral use is 180-days. |
| Design | Image: Healing Cap | Image: Healing Cap | Image: Healing Cap |
| Diameter (Ø) | 4.9, 6.8 mm | 4.0, 5.0, 5.2, 6.0 mm | 5.0, 6.0, 6.9 mm |
| Total Length | 4.2 mm | 3.65, 3.7, 3.75, 5.0 mm | 4.1, 5.5 mm |
| ConnectionInterface | Two-piece Healing Cap(with titanium alloy screw) | Two-piece Healing Cap(with titanium alloy screw) | One-piece Healing Cap(with integrated screw) |
| Material | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) | Ti-6Al-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined | Machined | Not Known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Sterile (Gamma) |
| Principle ofOperation | Healing Cap is used forprotecting Multi-unit Abutmentor Multi-unit Angled Abutmentand minimizing irritation totongue and oral mucosa duringperiod of gingival healing. | Healing Cap is used forprotecting Abutment andminimizing irritation to tongueand oral mucosa during periodof gingival healing. | The Healing Cap Multi-unitTitanium is used for protectingMulti-unit Abutment andminimizing irritation to tongueand oral mucosa during periodof gingival healing. |
| CompatibleImplantSystem | Xpeed AnyRidge InternalImplant SystemAnyOne Internal Implant SystemAnyRidge Octa1 Internal ImplantSystem | AnyOne Internal Implant System | Nobel Biocare Multi UnitAbutments |
1. Similarities
- The subject device has the same characteristic for the followings compared to the reference device 1.
- ı Indication for use, Design, Connection Interface, Material, Surface Treatment, Sigle Use, Sterilization and Principle of Operation
2. Differences
-
The subject device has the different characteristic for the followings compared to the reference device 1.
ı Diameter, Total Length -
The Diameter and Length of subject device is slightly different with reference device 1 but all the diameters and lengths of subject device lie within combined range of reference device 1 & 2.
3. Discussion
- । The proposed Healing Cap is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Healing Cap and reference devices have common in Indication for use, Design, Connection Interface, Material, Surface Treatment, Sigle Use, Sterilization and Principle of Operation. The dimension is slightly different with reference devices, but it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the reference devices.
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Temporary Cylinder
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Temporary CylinderFor Multi-unit Abutment, Multi-unit Angled Abutment | Temporary AbutmentFor AnyRidge Octa 1 Implant System | Temporary CylinderFor AnyOne Internal ImplantSystem |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indicationsfor UseStatement | The Multi-unit Abutment, Multi-unitAngled Abutment is intended to besurgically placed in the maxillary ormandibular arches for the purposeproviding prosthetic support fordental restorations (Crown, bridges,and overdentures) in partially or fullyedentulous individuals. | The AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing functionin the following situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. | The AnyOne Internal Implant Systemis intended to be surgically placed inthe maxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Smaller implants (less than 6.0 mm)are dedicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implants arededicated for the molar region andare indicated for delayed loading. |
| Design | Image: Design of Temporary Cylinder | Image: Design of Temporary Abutment | Image: Design of Temporary Cylinder |
| Diameter (Ø) | 4.8 mm | 4.0, 4.5, 5.0 mm | 3.87, 4.8, 5.8 mm |
| Total Length | 12.0 mm | 14.85, 15.85, 16.35, 17.35 mm | 10.0, 12.35 mm |
| Post Height | 8.5 mm | 10 mm | 7.0, 7,5 mm |
| Gingival (Cuff)Height | 3.0 mm | 2.0, 3.0 mm | 2.8, 3.0 mm |
| Angulation | Straight | Straight | Straight |
| ConnectionInterface | Internal Non-Hex | Internal Octa,Internal Non-Octa | Internal Octa, Non-OctaInternal Hex, Non-Hex |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 4(ASTM F67-13) |
| SurfaceTreatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| RestorationType | Single & Multi | Single & Multi | Single & Multi |
| Principle ofOperation | Temporary Cylinder is used inconjunction with Multi-unit(Angled) Abutment (N type) toprovide support for provisionalrestoration. | Temporary Abutment is used inconjunction with Fixture toprovide support for provisionalrestoration. | Temporary Cylinder is used inconjunction with Octa Abutmentand Multi-unit (Angled)Abutment (S type) to providesupport for provisionalrestoration. |
| CompatibleImplantSystem | Xpeed AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemAnyRidge Octa1 InternalImplant System | AnyRidge Octa1 InternalImplant System | AnyOne Internal ImplantSystem |
| Substantial Equivalence Discussion | |||
| 1. SimilaritiesThe subject device has the same characteristic for the followings compared to the predicate device & referencedevice. |
{19}------------------------------------------------
- Indication for use, Design, Diameter, Gingival (Cuff) Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Restoration type and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device & reference device.
- ı Total Length, Post Height The Total Length and Post Height of subject device is slightly different with predicate device, but all the dimensions of subject device lie within combined range of predicate and reference device.
3. Discussion
၊ The proposed Temporary Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed Temporary Cylinder and predicate devices have common in Indication for use, Design, Diameter, Gingival (cuff) Height, Angulation, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Restoration type and Principle of Operation.
The dimension is slightly different with predicate device, but it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size and angle can be possible to operate more precise treatment to meet each patient's condition. Also, the fatigue testing is not considered since the proposed device is a straight type and temporarily used.
On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
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CCM Cylinder
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 | K123988 | |
| Device Name | CCM CylinderFor Multi-unitAbutment, Multi-unitAngled Abutment | CCM AbutmentFor AnyRidge Octa 1Implant System | CCM CylinderFor AnyOne InternalImplant System | CCM AbutmentFor AnyOne InternalImplant System | |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indicationsfor UseStatement | The Multi-unit Abutment,Multi-unit AngledAbutment is intended tobe surgically placed in themaxillary or mandibulararches for the purposeproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. | The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary ormandibular arches for thepurpose of providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction in the followingsituations and with theclinical protocols:-Delayed loading.-Immediate loading whengoodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region. | The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction. Smaller implants(less than 6.0 mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading. | The AnyOne InternalImplant System is intendedto be surgically placed inthe maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction. Smaller implants(less than 6.0 mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading. | |
| Design | |||||
| Diameter (Ø) | 4.8 mm | 3.8 mm | 4.0, 5.1, 6.0 mm | 4.5 mm | |
| Total Length | 13.0, 15.0 mm | 14.65, 16.15 mm | 12.0 mm | 15.7 mm | |
| Post Height | 10.0, 13.0 mm | 11.6 mm | 10.0 mm | 12.0 mm | |
| Gingival (Cuff)Heights | 2.0, 3.0 mm | 1.0 mm | 2.0 mm | 1.0 mm | |
| Angulation | Straight | Straight | Straight | Straight | |
| ConnectionInterface | Internal Hex,Internal Non-Hex | Internal Octa,Internal Non-Octa | Internal Octa,Internal Non-Octa | Internal Hex,Internal Non-Hex | |
| Material | Body: Co-Cr-Mo AlloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM | Body: Co-Cr-Mo AlloySleeve: POM | |
| SurfaceTreatment | N/A | N/A | N/A | N/A | |
| Single Use | Yes | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | |
| RestorationType | Single & Multi | Single & Multi | Single & Multi | Single & Multi | |
| Principle ofOperation | CCM Cylinder is used inconjunction with Multi-unit (Angled) Abutment(N & S type) to providesupport for screw typefinal prosthesis bycasting with non-precious metal alloy(Co-Cr-Mo Alloy). | CCM Abutment is usedin conjunction withFixture to providesupport for screw typefinal prosthesis bycasting with non-precious metal alloy(Co-Cr-Mo Alloy). | CCM Cylinder is used inconjunction with OctaAbutment to providesupport for screw typefinal prosthesis bycasting with non-precious metal alloy(Co-Cr-Mo Alloy). | CCM Abutment is usedin conjunction withFixture to providesupport for screw typefinal prosthesis bycasting with non-precious metal alloy(Co-Cr-Mo Alloy). | |
| Compatible | Xpeed AnyRidge | AnyRidge Octa1 Internal | AnyOne Internal | AnyOne Internal | |
| Implant System | Internal Implant SystemAnyOne InternalImplant SystemAnyRidge Octa1 InternalImplant System | Implant System | Implant System | Implant System | |
| Substantial Equivalence Discussion | |||||
| 1. | Similarities | ||||
| The subject device has the same characteristic for the followings compared to the predicate device & reference devices. | |||||
| - Indication for use, Design, Angulation, Material, Surface Treatment, Single Use, Sterilization, Restoration type and Principle of Operation | |||||
| 2. | Differences | ||||
| The subject device has the different characteristic for the followings compared to the predicate device & reference devices. | |||||
| - Diameter, Total Length, Post Height, Gingival (Cuff) Height | |||||
| The diameter and Total length of subject device is slightly different with predicate device, but all the dimensions of subject device lie within range of predicate and reference devices. | |||||
| The subject device has same Post Height and Cuff Height as reference device 1 for P.H 10.0mm and G.H 2.0mm. | |||||
| The only difference is that slight longer Post Height(13.0mm) and Cuff Height(3.0mm) are added in the subject device, but the total length of subject device lie within combined range of predicate and reference devices. | |||||
| - Connection Interface | |||||
| The subject device has Hex / Non-Hex connection while the predicate device has Octa / Non-Octa connection. However, the connection difference can be covered by the reference device 2. Also, both feature of Hex and Octa provides anti-rotational feature. | |||||
| 3. | Discussion | ||||
| - The proposed CCM Cylinder is being submitted to add in Megagen's existing prosthetic portfolio which had been FDA cleared. Therefore, the proposed CCM Cylinder and predicate & reference device have common in Indication for use, Design, Angulation, Material, Surface Treatment, Single Use, Sterilization, Restoration type and Principle of Operation. The dimension is slightly different with predicate device, but it does not cause a matter in substantial equivalence since the size difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. Also, the fatigue testing is not considered since the proposed device is straight type. | |||||
| On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device. |
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Cylinder Screw
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203808 | K123988 | K052369 |
| Device Name | Cylinder ScrewFor Multi-unit Abutment, Multi-unit Angled Abutment | Flat Cylinder ScrewFor AnyOne Internal ImplantSystem | Cylinder ScrewFor ExFeel Dental Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for UseStatement | The Multi-unit Abutment, Multi-unit Angled Abutment is intendedto be surgically placed in themaxillary or mandibular arches forthe purpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. | The AnyOne Internal ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, and overdentures)in partially or fully edentulousindividuals. It is used to restore apatient's chewing function. Smallerimplants (less than 6.0 mm) arededicated for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Larger implantsare dedicated for the molar regionand are indicated for delayedloading. | The ExFeel Dental Implant Systemsare intended to be placed in theupper or lower jaw to supportprosthetic devices, such as artificialteeth, and to restore a patient'schewing function. This may beaccomplished using either a twostage surgical procedure or a singlestage surgical procedure. |
| Design | Image: Cylinder Screw | Image: Flat Cylinder Screw | Image: Cylinder Screw |
| Diameter (Ø) | 2.0 mm | 2.1 mm | 2.5 mm |
| Total Length | 3.4 mm | 5.9 mm | 4.85 mm |
| ConnectionInterface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6Al-4V ELI(ASTM F136-13) | Ti-6Al-4V ELI(ASTM F136-13) | CP Ti Grade 3(ASTM F67-13) |
| Surface Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | Cylinder Screw is used forconnecting Multi-unitAbutment or Multi-unit AngledAbutment to Healing Cap,Temporary cylinder or CCMCylinder. | Flat Cylinder Screw is used forconnecting Abutment toHealing Cap or Cylinder. | Cylinder Screw is used forconnecting Abutment toHealing Cap or Cylinder. |
| CompatibleImplant System | Xpeed AnyRidge InternalImplant SystemAnyOne Internal ImplantSystemAnyRidge Octa1 InternalImplant System | AnyOne Internal ImplantSystem | ExFeel Dental Implant System |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device 1.
- Indication for use, Design, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the followings compared to the reference device 1.
- ı Diameter, Total Length
The Diameter and Total Length of subject device is slightly different with reference devices but it does not cause a matter in substantial equivalence since the difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
- The proposed Cylinder Screw is being submitted to add in Megagen's existing prosthetic portfolio which had been
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FDA cleared. Therefore, the proposed Cylinder Screw and reference devices have common in Indication for use, Design, Connection Interface, Material, Surface Treatment, Single Use, Sterilization and Principle of Operation. The size difference is explained not affecting on the substantial equivalence.
On the basis of the discussion above, it is concluded that the substantially equivalent to the reference devices.
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8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The additional biocompatibility testing is not required on the Multi-unit Abutment, Multi-unit Angled Abutment since these have same material composition, manufacturing process and patient contacting parts as predicate devices, AnyOne Internal Implant System (K123988) and AnyRidge Octa 1 Implant System (K182448).
Modified Surface Treatment
The surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment.
The Multi-unit Abutment, Multi-unit Angled Abutment have same surface treatment and manufacturing process as predicate devices, AnyOne Internal Implant System(K123988) and AnyRidge Octa 1 Implant System (K182448) for the Anodizing method.
Sterilization validation
The subject device is supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterlility assurance level (10-6).
Performance (Physical Properties) Test
The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental
lmplant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria.
9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the Multi-unit Abutment, Multi-unit Angled Abutment is substantially equivalent to the predicate device as herein.
§ 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.)