(296 days)
No
The document describes a mechanical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device provides prosthetic support for dental restorations, restoring chewing function, which is a supportive rather than a therapeutic action.
No
The device is a Multi-unit Abutment, Multi-unit Angled Abutment intended for providing prosthetic support for dental restorations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical component (abutment) of a dental implant system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide prosthetic support for dental restorations in the mouth (maxillary or mandibular arches). This is a direct interaction with the patient's anatomy for a structural purpose.
- Device Description: The device is described as a component of a dental implant system used to support tooth replacements and restore chewing function. This is a mechanical function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a structural component.
N/A
Intended Use / Indications for Use
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.
Product codes
NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arches
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 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". Not required for this device due to similar material composition, manufacturing process, and patient contacting parts as predicate devices.
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 device has the same surface treatment and manufacturing process as referenced predicate devices 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 sterility 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 Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K123988, K192401, K201621, K141457, K110955, K171142, K052369
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 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.
1
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
2
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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==============================================================================================================================================================================
3
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
4
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 Implant
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|---------------------------------------|--------------------|------------------|--------------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | Xpeed AnyRidge
Internal Implant
System | Xpeed
AnyRidge
Internal Fixture | K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4,
5.9, 6.4, 6.9, 7.4,
7.9, 8.4 |
| | AnyOne
Internal Implant
System | AnyOne
Internal Fixture | K123988 | Internal
Hex | 3.9, 4.3, 4.8, 5.3,
5.8, 6.3, 6.8, 7.3,
7.8, 8.3 |
| | AnyRidge Octa 1
Implant System | AnyRidge Octa
1 Fixture | K182448 | Internal
Octa | 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 System | ||
| AnyOne Internal Implant System | |||
| AnyRidge 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° | ||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System | |||
| Multi-unit | |||
| Abutment | |||
| Screw | 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 & AnyOne | ||
| Multi-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 mm | ||
| Ø 2.2 x 4.4 mm | |||
| Ø 2.4 x 6.8 mm | |||
| Ø 2.95 x 10.8, 11.5, 11.8, 12.5, 12.8, 13.5, 13.8, 14.5, 15.5 mm | |||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System | |||
| Abutment | |||
| Screw | 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 | ||
| Compatible | |||
| Implant System | AnyOne Internal Implant System | ||
| Multi Post | |||
| Screw | 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 | ||
| Compatible | |||
| Implant 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 mm | ||
| Ø 6.8 x 4.20 mm | |||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System | |||
| Temporary | |||
| Cylinder | 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 | ||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System | |||
| CCM | |||
| Cylinder | Description | The CCM Cylinder is used in conjunction with Multi-unit | |
| (Angled) Abutment to provide support for screw type final | |||
| prosthesis by casting with non-precious metal alloy (Co-Cr-Mo | |||
| Alloy). 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 | ||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System | |||
| Cylinder | |||
| Screw | 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 | ||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal Implant System | ||
| AnyOne Internal Implant System | |||
| AnyRidge Octa 1 Implant System |
5
6
[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'.
7
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.
8
Multi-unit Abutment
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 | K192401 | |
| Device Name | Multi-unit Abutment | ||||
| For Multi-unit Abutment, | |||||
| Multi-unit Angled | |||||
| Abutment | Multi-unit Abutment | ||||
| For AnyRidge Octa 1 Implant | |||||
| System | Multi-unit Abutment | ||||
| For AnyOne Internal Implant | |||||
| System | Straumann® Screw- | ||||
| Retained Abutments | |||||
| Manufacturer | MegaGen Implant Co., | ||||
| Ltd. | MegaGen Implant Co., | ||||
| Ltd. | MegaGen Implant Co., | ||||
| Ltd. | Straumann USA, LLC | ||||
| Indications | |||||
| for Use | |||||
| Statement | 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. | The AnyRidge Octa 1 | ||||
| Implant System is intended | |||||
| to be surgically placed in | |||||
| the maxillary or | |||||
| mandibular arches for the | |||||
| purpose of 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 in the | |||||
| following situations and | |||||
| with the clinical protocols: | |||||
| -Delayed loading. | |||||
| -Immediate loading when | |||||
| good primary stability is | |||||
| achieved and with | |||||
| appropriate occlusal | |||||
| loading. Larger implants | |||||
| are dedicated for the molar | |||||
| region. | 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 6.0 | |||||
| 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. | Prosthetic components | ||||
| directly or indirectly | |||||
| connected to the | |||||
| endosseous dental implant | |||||
| are intended for use as an | |||||
| aid in prosthetic | |||||
| rehabilitations. Temporary | |||||
| components can be used | |||||
| prior to the insertion of the | |||||
| final components to | |||||
| maintain, stabilize and | |||||
| shape the soft tissue | |||||
| during the healing phase; | |||||
| they are to be placed out | |||||
| of occlusion. Final | |||||
| abutments may be placed | |||||
| into occlusion for implants | |||||
| with sufficient primary | |||||
| stability or for implants | |||||
| that are fully | |||||
| osseointegrated. | |||||
| Temporary Abutments | |||||
| have a maximum duration | |||||
| of 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, 12.8 | ||||
| mm | 6.2, 7.2, 8.2, 9.2, 10.2 | ||||
| mm | Not Known | ||||
| Post Height | 1.8, 2.2 mm | 2.2 mm | 1.8 mm | Not Known | |
| Gingival | |||||
| Height | 0.6, 1.5, 2.0, 2.5, 3.0, | ||||
| 3.5, 4.0, 4.5, 5.0, 5.5 | |||||
| mm | 1.3, 2.3, 3.3, 4.3 mm | 1.5, 2.5, 3.5, 4.5, 5.5 | |||
| mm | 1.5, 2.5, 3.5, 4.5 and | ||||
| 5.5 mm | |||||
| Angulation | Straight | Straight | Straight | Straight | |
| Connection | |||||
| Interface | Internal Hex, | ||||
| Internal Non-Hex, | |||||
| Internal Conical | |||||
| Connection | Internal Conical | ||||
| Connection | 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 | ||||
| Surface | |||||
| Treatment | Anodizing | Anodizing, Machined | Anodizing | Anodizing | |
| Single Use | Yes | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Gamma Irradiation | |
| Restoration | |||||
| Type | Single & Multi | Single & Multi | Single & Multi | Single & Multi | |
| Principle of | |||||
| Operation | This product is a pre- | ||||
| manufactured | |||||
| prosthetic component | |||||
| directly or indirectly | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using its | |||||
| threaded part or screw | |||||
| for aid in prosthetic | |||||
| rehabilitation. | This product is a pre- | ||||
| manufactured | |||||
| prosthetic component | |||||
| directly connected to | |||||
| the endosseous dental | |||||
| implant using its | |||||
| threaded part for aid in | |||||
| prosthetic | |||||
| rehabilitation. | This product is a pre- | ||||
| manufactured | |||||
| prosthetic component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the screw | |||||
| for aid in prosthetic | |||||
| rehabilitation. | This product is a pre- | ||||
| manufactured | |||||
| prosthetic component | |||||
| directly connected to | |||||
| the endosseous dental | |||||
| implant using its | |||||
| threaded part for aid in | |||||
| prosthetic | |||||
| rehabilitation. | |||||
| Compatible | |||||
| Implant | |||||
| System | Xpeed AnyRidge | ||||
| Internal Implant System | |||||
| AnyOne Internal | |||||
| Implant System | |||||
| AnyRidge Octa 1 | |||||
| Implant System | AnyRidge Octa 1 | ||||
| Implant System | AnyOne Internal | ||||
| Implant System | Straumann® Bone | ||||
| Level 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 Angled | ||||
| Abutment | |||||
| For Multi-unit | |||||
| Abutment, Multi-unit | |||||
| Angled Abutment | Multi-unit Angled | ||||
| Abutment | |||||
| For AnyRidge Octa 1 | |||||
| Implant System | Straumann® | ||||
| Screw-Retained | |||||
| Abutments | Magic Multiunit | ||||
| Abutment | |||||
| For Magicore II | |||||
| System | Angled Screw | ||||
| Abutment | |||||
| Dentium | |||||
| Implantium® and | |||||
| SuperLine® | |||||
| Abutments | |||||
| Manufacturer | MegaGen Implant | ||||
| Co., Ltd. | MegaGen Implant | ||||
| Co., Ltd. | Straumann USA, | ||||
| LLC | InnoBioSurg Co., | ||||
| Ltd. | Dentium Co., Ltd. | ||||
| Indications | |||||
| for Use | |||||
| Statement | 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. | The AnyRidge Octa 1 | ||||
| Implant System is | |||||
| intended to be | |||||
| surgically placed in | |||||
| the maxillary or | |||||
| mandibular arches | |||||
| for the purpose of | |||||
| 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 in | |||||
| the following | |||||
| situations and with | |||||
| the clinical protocols: | |||||
| -Delayed loading. | |||||
| -Immediate loading | |||||
| when good | |||||
| primary stability is | |||||
| achieved and with | |||||
| appropriate occlusal | |||||
| loading. Larger | |||||
| implants are | |||||
| dedicated for the | |||||
| molar region. | Prosthetic | ||||
| components directly | |||||
| or indirectly | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant are intended | |||||
| for use as an aid in | |||||
| prosthetic | |||||
| rehabilitations. | |||||
| Temporary | |||||
| components can be | |||||
| used prior to the | |||||
| insertion of the final | |||||
| components to | |||||
| maintain, stabilize | |||||
| and shape the soft | |||||
| tissue during the | |||||
| healing phase; they | |||||
| are to be placed out | |||||
| of occlusion. Final | |||||
| abutments may be | |||||
| placed into occlusion | |||||
| for implants with | |||||
| sufficient primary | |||||
| stability or for | |||||
| implants that are | |||||
| fully | |||||
| osseointegrated. | |||||
| Temporary | |||||
| Abutments have a | |||||
| maximum duration | |||||
| of usage of 180 days. | The Magicore II | ||||
| System is intended to | |||||
| replace missing teeth | |||||
| to restore chewing | |||||
| function. The | |||||
| Magicore II | |||||
| System can be placed | |||||
| in support of single | |||||
| or multiple-unit | |||||
| restorations | |||||
| including; cement | |||||
| retained, screw | |||||
| retained, or | |||||
| overdenture | |||||
| restorations, and | |||||
| terminal or | |||||
| immediate abutment | |||||
| support for fixed | |||||
| bridgework. | |||||
| This system is for one | |||||
| or two stage surgical | |||||
| procedures. This | |||||
| system is intended | |||||
| for delayed loading. | Dentium Prosthetics | ||||
| are intended for use | |||||
| as an aid in | |||||
| prosthetic | |||||
| rehabilitation. | |||||
| 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 |
| Gingival | |||||
| Height | 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, 4.5 | |||
| and 5.5 mm | 1.5, 2.5, 3.5, 4.5 | ||||
| mm | 1.0 to 1.5 mm | ||||
| Angulation | 17°, 29°, 30° | 17°, 30° | 1.5, 2.5, 3.5, 4.5 | ||
| and 5.5 mm | 5°, 10°, 20° | 15° to 30° | |||
| Connection | |||||
| Interface | Internal Hex, | ||||
| Internal Non-Hex, | |||||
| Internal Octa, | |||||
| Internal Non- | |||||
| Octa | Internal Octa, | ||||
| Internal Non- | |||||
| Octa | CrossFit® (NC and | ||||
| RC) (with conical | |||||
| fitting) | 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) | |||||
| Surface | |||||
| Treatment | Anodizing | Machined | Anodizing | Machined | Tin Coated |
| Single Use | Yes | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Gamma | ||
| Irradiation | Non-sterile | Non-sterile | |||
| Restoration | |||||
| Type | Single & Multi | Single & Multi | Single & Multi | Single & Multi | Not Known |
| Principle of | |||||
| Operation | This product is a | ||||
| pre-manufactured | |||||
| prosthetic | |||||
| component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the | |||||
| screw and is | |||||
| intended for use as | |||||
| an aid in prosthetic | |||||
| rehabilitation. | This product is a | ||||
| pre-manufactured | |||||
| prosthetic | |||||
| component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the | |||||
| screw and is | |||||
| intended for use as | |||||
| an aid in prosthetic | |||||
| rehabilitation. | This product is a | ||||
| pre-manufactured | |||||
| prosthetic | |||||
| component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the | |||||
| screw and is | |||||
| intended for use as | |||||
| an aid in prosthetic | |||||
| rehabilitation. | This product is a | ||||
| pre-manufactured | |||||
| prosthetic | |||||
| component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the | |||||
| screw and is | |||||
| intended for use as | |||||
| an aid in prosthetic | |||||
| rehabilitation. | This product is a | ||||
| pre-manufactured | |||||
| prosthetic | |||||
| component | |||||
| connected to the | |||||
| endosseous dental | |||||
| implant using the | |||||
| screw and is | |||||
| intended for use as | |||||
| an aid in prosthetic | |||||
| rehabilitation. | |||||
| Compatible | |||||
| Implant | |||||
| System | Xpeed AnyRidge | ||||
| Internal Implant | |||||
| System | |||||
| AnyOne Internal | |||||
| Implant System | |||||
| AnyRidge Octa 1 | |||||
| Implant System | AnyRidge Octa 1 | ||||
| Implant System | Straumann® Bone | ||||
| Level Implants | Magicore II | ||||
| System | Dentium | ||||
| Implantium and | |||||
| SuperLine | |||||
| Substantial Equivalence Discussion |
9
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.
10
Multi-unit Angled Abutment
11
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 ।
12
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.
13
Multi-unit Abutment Screw
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Multi-unit Abutment Screw | ||
| For Multi-unit Abutment, Multi-unit | |||
| Angled Abutment | Multi-unit Abutment Screw | ||
| For AnyRidge Octa 1 Implant System | Multi-unit Abutment Screw | ||
| For AnyOne Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | 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. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose | |||
| of 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 in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | 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 6.0 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. | |||
| 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, 15.5 | |||
| mm | 7.0 mm | 11.5, 12.5, 13.5, 14.5, 15.5 | |
| mm | |||
| Connection | |||
| Interface | 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) | |||
| Surface | |||
| Treatment | Machined, Anodizing | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | Multi-unit Abutment Screw is | ||
| used for connecting Multi-unit | |||
| Abutment or Multi-unit Angled | |||
| Abutment to the fixture. | Multi-unit Abutment Screw is | ||
| used for connecting Multi-unit | |||
| Abutment or Multi-unit Angled | |||
| Abutment to the fixture. | Multi-unit Abutment Screw is | ||
| used for connecting Multi-unit | |||
| Abutment to the fixture. | |||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal | ||
| Implant System | |||
| AnyOne Internal Implant | |||
| System | AnyRidge Octa1 Internal | ||
| Implant System | AnyOne Internal Implant | ||
| System | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the predicate device & reference | |||
| Device. |
- Indication for use, Design, Connection Interface, Material, Single Use, Sterilization and Principle of Operation | | | |
| 2. Differences
The subject device has the different characteristic for the followings compared to the predicate device & reference
Device. - Diameter, Total Length
The Diameter of subject device is slightly different with predicate device but all the diameters of subject device lie
within 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 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. - 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.
14
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.
15
Abutment Screw
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Abutment Screw | ||
| For Multi-unit Abutment, Multi-unit | |||
| Angled Abutment | Abutment Screw | ||
| For AnyRidge Octa 1 Implant System | Abutment Screw | ||
| For AnyOne Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | |||
| Use Statement | 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. | The AnyRidge Octa 1 Implant | ||
| System is intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular arches for the purpose | |||
| of 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 in the following situations | |||
| and with the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate occlusal loading. | |||
| Larger implants are dedicated for | |||
| the molar region. | 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 6.0 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. | |||
| 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 |
| Connection | |||
| Interface | 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) |
| Surface | |||
| Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Principle of | |||
| Operation | Abutment screw is used for is | ||
| used for connecting Multi-unit | |||
| Angled Abutment to the fixture. | Abutment screw is used for is | ||
| used for connecting the | |||
| Abutment to the fixture. | Abutment screw is used for is | ||
| used for connecting the | |||
| Abutment to the fixture. | |||
| Compatible | |||
| Implant System | AnyOne Internal Implant | ||
| System | AnyRidge Octa1 Internal | ||
| Implant System | AnyOne Internal Implant | ||
| System |
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.
16
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 for | ||
| Use | ||
| Statement | 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. | The AnyRidge 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 o6.0 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. | ||
| 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 |
| Connection | ||
| Interface | Internal Conical Connection | Internal Conical Connection |
| Ti-6Al-4V ELI | Ti-6Al-4V ELI | |
| Material | (ASTM F136-13) | (ASTM F136-13) |
| Surface | ||
| Treatment | Anodizing | Anodizing |
| Single Use | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
| Principle of | ||
| Operation | Multi Post Screw is used for connecting Multi-unit | |
| Angled Abutment to the Fixture. | Multi Post Screw is used for connecting the | |
| Abutment to the Fixture. | ||
| Compatible | ||
| Implant | ||
| System | 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.
17
Healing Cap
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203808 | K123988 | K171142 |
| Device | |||
| Name | Healing Cap | ||
| For Multi-unit Abutment, Multi-unit | |||
| Angled Abutment | Healing Cap | ||
| For AnyOne Internal Implant System | Healing Cap Multi-Unit | ||
| Titanium | |||
| For Nobel Biocare Multi Unit | |||
| Abutments | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Nobel Biocare USA LLC |
| Indications for | |||
| Use | |||
| Statement | 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. | 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 6.0 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. | 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. | |||
| 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 |
| Connection | |||
| Interface | 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) |
| Surface | |||
| Treatment | Machined | Machined | Not Known |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Sterile (Gamma) |
| Principle of | |||
| Operation | Healing Cap is used for | ||
| protecting Multi-unit Abutment | |||
| or Multi-unit Angled Abutment | |||
| and minimizing irritation to | |||
| tongue and oral mucosa during | |||
| period of gingival healing. | Healing Cap is used for | ||
| protecting Abutment and | |||
| minimizing irritation to tongue | |||
| and oral mucosa during period | |||
| of gingival healing. | The Healing Cap Multi-unit | ||
| Titanium is used for protecting | |||
| Multi-unit Abutment and | |||
| minimizing irritation to tongue | |||
| and oral mucosa during period | |||
| of gingival healing. | |||
| Compatible | |||
| Implant | |||
| System | Xpeed AnyRidge Internal | ||
| Implant System | |||
| AnyOne Internal Implant System | |||
| AnyRidge Octa1 Internal Implant | |||
| System | AnyOne Internal Implant System | Nobel Biocare Multi Unit | |
| Abutments |
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.
18
Temporary Cylinder
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 |
| Device Name | Temporary Cylinder | ||
| For Multi-unit Abutment, Multi- | |||
| unit Angled Abutment | Temporary Abutment | ||
| For AnyRidge Octa 1 Implant System | Temporary Cylinder | ||
| For AnyOne Internal Implant | |||
| System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications | |||
| for Use | |||
| Statement | 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. | The AnyRidge Octa 1 Implant System | ||
| is intended to be surgically placed in | |||
| the maxillary or mandibular arches | |||
| for the purpose of 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 | |||
| in the following situations and with | |||
| the clinical protocols: | |||
| -Delayed loading. | |||
| -Immediate loading when good | |||
| primary stability is achieved and with | |||
| appropriate occlusal loading. Larger | |||
| implants are dedicated for the molar | |||
| region. | 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 6.0 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. | |||
| 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 |
| Connection | |||
| Interface | Internal Non-Hex | Internal Octa, | |
| Internal Non-Octa | Internal Octa, Non-Octa | ||
| Internal 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) | |||
| Surface | |||
| Treatment | Machined | Machined | Machined |
| Single Use | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Restoration | |||
| Type | Single & Multi | Single & Multi | Single & Multi |
| Principle of | |||
| Operation | Temporary Cylinder is used in | ||
| conjunction with Multi-unit | |||
| (Angled) Abutment (N type) to | |||
| provide support for provisional | |||
| restoration. | Temporary Abutment is used in | ||
| conjunction with Fixture to | |||
| provide support for provisional | |||
| restoration. | Temporary Cylinder is used in | ||
| conjunction with Octa Abutment | |||
| and Multi-unit (Angled) | |||
| Abutment (S type) to provide | |||
| support for provisional | |||
| restoration. | |||
| Compatible | |||
| Implant | |||
| System | Xpeed AnyRidge Internal | ||
| Implant System | |||
| AnyOne Internal Implant | |||
| System | |||
| AnyRidge Octa1 Internal | |||
| Implant System | AnyRidge Octa1 Internal | ||
| Implant System | AnyOne Internal Implant | ||
| System | |||
| Substantial Equivalence Discussion | |||
| 1. Similarities | |||
| The subject device has the same characteristic for the followings compared to the predicate device & reference | |||
| device. |
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.
20
CCM Cylinder
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | ||
|---|---|---|---|---|---|
| 510(k) No. | K203808 | K182448 | K123988 | K123988 | |
| Device Name | CCM Cylinder | ||||
| For Multi-unit | |||||
| Abutment, Multi-unit | |||||
| Angled Abutment | CCM Abutment | ||||
| For AnyRidge Octa 1 | |||||
| Implant System | CCM Cylinder | ||||
| For AnyOne Internal | |||||
| Implant System | CCM Abutment | ||||
| For AnyOne Internal | |||||
| Implant System | |||||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
| Indications | |||||
| for Use | |||||
| Statement | 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. | The AnyRidge Octa 1 | ||||
| Implant System is intended | |||||
| to be surgically placed in | |||||
| the maxillary or | |||||
| mandibular arches for the | |||||
| purpose of 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 in the following | |||||
| situations and with the | |||||
| clinical protocols: | |||||
| -Delayed loading. | |||||
| -Immediate loading when | |||||
| good | |||||
| primary stability is | |||||
| achieved and with | |||||
| appropriate occlusal | |||||
| loading. Larger implants | |||||
| are dedicated for the | |||||
| molar region. | 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 6.0 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. | 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 6.0 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. | |||||
| 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 | |
| Connection | |||||
| Interface | 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 Alloy | ||||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||||
| Sleeve: POM | Body: Co-Cr-Mo Alloy | ||||
| Sleeve: POM | |||||
| Surface | |||||
| Treatment | N/A | N/A | N/A | N/A | |
| Single Use | Yes | Yes | Yes | Yes | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | |
| Restoration | |||||
| Type | Single & Multi | Single & Multi | Single & Multi | Single & Multi | |
| Principle of | |||||
| Operation | CCM Cylinder is used in | ||||
| conjunction with Multi- | |||||
| unit (Angled) Abutment | |||||
| (N & S type) to provide | |||||
| support for screw type | |||||
| final prosthesis by | |||||
| casting with non- | |||||
| precious metal alloy | |||||
| (Co-Cr-Mo Alloy). | CCM Abutment is used | ||||
| in conjunction with | |||||
| Fixture to provide | |||||
| support for screw type | |||||
| final prosthesis by | |||||
| casting with non- | |||||
| precious metal alloy | |||||
| (Co-Cr-Mo Alloy). | CCM Cylinder is used in | ||||
| conjunction with Octa | |||||
| Abutment to provide | |||||
| support for screw type | |||||
| final prosthesis by | |||||
| casting with non- | |||||
| precious metal alloy | |||||
| (Co-Cr-Mo Alloy). | CCM Abutment is used | ||||
| in conjunction with | |||||
| Fixture to provide | |||||
| support for screw type | |||||
| final prosthesis by | |||||
| casting with non- | |||||
| precious metal alloy | |||||
| (Co-Cr-Mo Alloy). | |||||
| Compatible | Xpeed AnyRidge | AnyRidge Octa1 Internal | AnyOne Internal | AnyOne Internal | |
| Implant System | Internal Implant System | ||||
| AnyOne Internal | |||||
| Implant System | |||||
| AnyRidge Octa1 Internal | |||||
| Implant 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. |
21
22
Cylinder Screw
| Subject Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| 510(k) No. | K203808 | K123988 | K052369 |
| Device Name | Cylinder Screw | ||
| For Multi-unit Abutment, Multi- | |||
| unit Angled Abutment | Flat Cylinder Screw | ||
| For AnyOne Internal Implant | |||
| System | Cylinder Screw | ||
| For ExFeel Dental Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for Use | |||
| Statement | 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. | 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 6.0 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. | The ExFeel Dental Implant Systems | ||
| are intended to be placed in the | |||
| upper or lower jaw to support | |||
| prosthetic devices, such as artificial | |||
| teeth, and to restore a patient's | |||
| chewing function. This may be | |||
| accomplished using either a two | |||
| stage surgical procedure or a single | |||
| stage 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 |
| Connection | |||
| Interface | 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 of | |||
| Operation | Cylinder Screw is used for | ||
| connecting Multi-unit | |||
| Abutment or Multi-unit Angled | |||
| Abutment to Healing Cap, | |||
| Temporary cylinder or CCM | |||
| Cylinder. | Flat Cylinder Screw is used for | ||
| connecting Abutment to | |||
| Healing Cap or Cylinder. | Cylinder Screw is used for | ||
| connecting Abutment to | |||
| Healing Cap or Cylinder. | |||
| Compatible | |||
| Implant System | Xpeed AnyRidge Internal | ||
| Implant System | |||
| AnyOne Internal Implant | |||
| System | |||
| AnyRidge Octa1 Internal | |||
| Implant System | AnyOne Internal Implant | ||
| System | 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
23
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.
24
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.