(574 days)
The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
The BLUEDIAMOND IMPLANT is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar areas. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.
The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AL-4V ELI.
I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a dental implant system. This document is a regulatory submission for a medical device and does not contain information about studies proving that a device meets specific acceptance criteria in the context of an AI/ML-enabled medical device.
The document describes:
- The device (BLUEDIAMOND IMPLANT and Abutment Screw)
- Its intended use (dental restorations)
- Comparison with predicate devices for substantial equivalence (materials, design, sterilization, etc.)
- Non-clinical testing performed (biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, performance tests based on ISO standards)
- A statement that no clinical studies were submitted.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance (in the context of an AI/ML device): The document reports performance testing to ISO standards for dental implants (e.g., fatigue testing for mechanical properties) but does not provide acceptance criteria and reported performance in the manner requested for an AI/ML device (e.g., sensitivity, specificity thresholds).
- Sample size used for the test set and data provenance: Not applicable as no AI/ML study is reported.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of AI/ML. The device's "ground truth" for regulatory purposes relies on engineering and material standards.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document discusses non-clinical performance tests for mechanical properties (e.g., fatigue test according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment") to demonstrate substantial equivalence to predicate devices, but this is distinct from the type of performance data requested for an AI/ML-driven device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MegaGen Implant Co., Ltd. Hyo-Eun Lee Research Engineer 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu REPUBLIC OF KOREA
Re: K211812
Trade/Device Name: BLUEDIAMOND IMPLANT, Abutment Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 9, 2022 Received: December 12, 2022
Dear Hyo-Eun Lee:
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211812
Device Name BLUEDIAMOND IMPLANT, Abutment Screw
Indications for Use (Describe)
The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary – K211812
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date : January 6, 2023
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
Hyo-Eun Lee MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3860 Fax: +82-53-289-3420 Email: ra7@imegagen.com
3. Device
| • Trade Name: | BLUEDIAMOND IMPLANT, Abutment Screw |
|---|---|
| • Common Name: | Endosseous Dental Implant |
| • Classification Name: | Implant, Endosseous, Root-Form |
| • Primary Product Code: | DZE |
| • Secondary Product Code: | NHA |
- Class II, 21 CFR 872.3640 Classification regulation: .
4. Predicate Device
• Primary Predicate Device:
K063216 - Rescue Internal Implant System
• Reference Device:
K122231 - Xpeed AnyRidge Internal Implant System K182448 - AnyRidge Octa 1 Implant System K192347 – ST Internal Implant System
{4}------------------------------------------------
5. Description
The BLUEDIAMOND IMPLANT is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar areas. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.
The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AL-4V ELI.
| No. | Device | Content | |
|---|---|---|---|
| 1 | FixtureProductBLUEDIAMONDIMPLANT | Description | The BLUEDIAMOND IMPLANT System is intended to be surgically placed inthe maxillary or mandibular molar areas for the purpose providing prostheticsupport for dental restorations (Crown, bridges, and overdentures) inpartially or fully edentulous individuals. These implants can be used wheresmaller implants have failed. |
| Material | CP Ti Grade 4 of ASTM F67 | ||
| Widest Thread | $Ø$ 5.6 x 7.0, 7.7, 9.2, 10.7, 12.2, 14.2 mm | ||
| Dimension | $Ø$ 6.0 x 7.0, 7.7, 9.2, 10.7, 12.2, 14.2 mm | ||
| (Diameter & | $Ø$ 6.5 x 7.0, 7.7, 9.2, 10.7, 12.2, 14.2 mm | ||
| Total Length) | $Ø$ 7.0 x 7.0, 7.7, 9.2, 10.7, 12.2, 14.2 mm | ||
| 2 | AbutmentLevelProsthesisAbutment Screw | Description | Abutment Screw is used for securing the abutment to the endosseousimplant. |
| Material | Ti-6Al-4V ELI of ASTM F136-13 | ||
| Dimension(Diameter & Total Length) | $Ø$ 2.20 x 9.9 mm |
The BLUEDIAMOND IMPLANT is compatible with following Prosthesis made by our company cleared under;
| BLUEDIAMOND IMPLANT | 510(k) | ||||
|---|---|---|---|---|---|
| FDA-cleared/Subject device | Widest ThreadDiameter (mm) | Total Length(mm) | Fixture - AbutmentConnection Diameter (mm) | Prosthesis | Number |
| K182448 | 3.6, 4.0, 4.4, 4.7, 4.8,5.0, 5.5 | 7.0, 7.7, 9.2,10.7, 12.2, 14.2,17.2 | 2.8, 3.3 | EZ Post Abutment | K182448 |
| Angled Abutment | |||||
| Milling Abutment | |||||
| Meg-Rhein Abutment | |||||
| Multi-unit AbutmentMulti-unit Angled AbutmentCCM AbutmentOcta Abutment | |||||
| Subject device | 5.6, 6.0, 6.5, 7.0 | 7.0, 7.7, 9.2,10.7, 12.2, 14.2 | Healing Abutment | K192614 | |
| Temporary Abutment | |||||
| Fuse Abutment | |||||
| Meg-Ball Abutment | |||||
| Meg-Loc AbutmentMeg-Magnet Abutment |
The Abutment Screw, is compatible with following Abutment and implant by our company cleared under;
| Abutment Screw | Use for | Use for Fixture | ||
|---|---|---|---|---|
| Model Name | Height(mm) | Connection | Prosthesis (K182448) | (K182448 and Subject device) |
| AROAS16B,AROAS16(K182448) | 7.9, 9.9 | M1.6 | EZ Post Abutment | BLUEDIAMOND IMPLANT |
| Angled Abutment | ||||
| M1.6 | Milling Abutment | |||
| CCM Abutment | ||||
| Subject device | Temporary Abutment | |||
{5}------------------------------------------------
6. Indication for use
The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
{6}------------------------------------------------
7. Basis for Substantial Equivalence
The BLUEDIAMOND IMPLANT and Abutment screw are substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design and size.
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 device.
| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| 510k | K211812 | K063216 | K122231 | K182448 |
| Device Name(CompatibleImplant System) | BLUEDIAMOND IMPLANT | Rescue Internal ImplantSystem | XPEED AnyRidge Internal ImplantSystem | AnyRidge Octa 1 Implant System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| indication foruse | The BLUEDIAMOND IMPLANTSystem isintended to be surgically placedin the maxillary or mandibularmolar areas for the purpose ofproviding prosthetic supportfor dental restorations(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.These implants can be usedwhere smaller implants havefailed. | The Rescue Internal ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for the purposeof providing prostheticsupport for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulousindividuals.These implants are intendedto be used where smallerimplants have failed. | The Xpeed AnyRidge InternalImplant System is intended to besurgically placed 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 restorepatients 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 AnyRidge Octa 1 Implant Systemis intended to be surgically placed inthe maxillary or mandibular molararches for the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewing function inchewing function in the followingsituations and with the clinicalprotocols:- Delayed loading- Immediate loading when goodprimary stability is achieved and withappropriate occlusal loading. Largerimplants are dedicated for the molarregion. |
| Design | ||||
| Widest ThreadDiameter(Ø, mm) & TotalLength(mm) | - Normal thread$Ø5.6 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2$- Deep thread$Ø6.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2$$Ø6.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2$$Ø7.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2$ | $Ø6.0 X 7.0, 8.0, 9.5, 11.0, 12.5$$Ø6.5 X 7.0, 8.0, 9.5, 11.0, 12.5$$Ø7.0 X 7.0, 8.0, 9.5, 11.0, 12.5$$Ø8.0 X 7.0, 8.0, 9.5, 11.0, 12.5$ | - Normal thread$Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø5.4 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø5.9 X 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$- Deep thread$Ø6.4 X 7.9, 9.4, 10.9, 12.4, 14.4$$Ø6.9 X 7.9, 9.4, 10.9, 12.4, 14.4$$Ø7.4 X 7.9, 9.4, 10.9, 12.4, 14.4$$Ø7.9 X 7.9, 9.4, 10.9, 12.4, 14.4$$Ø8.4 X 7.9, 9.4, 10.9, 12.4, 14.4$ | - Normal thread$Ø3.6 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.7 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$- Deep thread$Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$$Ø5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2$ |
| Implant toAbutmentConnection | Octa | Hex | Hex | Octa |
| Material | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) |
| SurfaceTreatment | Sand-blasted, Large grit, Acid-etched (S.L.A) | Sand-blasted, Acid-etched(RBM) | Sand-blasted, Large grit, Acid-etched (S.L.A) | Sand-blasted, Large grit, Acid-etched(S.L.A) |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf Life | 5 Years | 5 Years | 5 Years | 5 Years |
| Feature | - Submerged implant- Tapered body- cutting edge with self-tapping | - Submerged implant- Mose Tapered body- cutting edge with self-tapping | - Submerged implant- Tapered body- cutting edge with self-tapping | - Submerged implant- Tapered body- cutting edge with self-tapping |
BLUEDIAMOND IMPLANT
{7}------------------------------------------------
| - 0.8mm thread pitch | ||||
|---|---|---|---|---|
| Principle ofOperation | This product is dental implantwhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. | This product is dental implantwhich is inserted inthe alveolar bone. It replacesthe functions of the missingteeth as a dental implantfixture. | This product is dental implantwhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. | This product is dental implant whichis inserted in the alveolar bone. Itreplaces the functions of the missingteeth as a dental implant fixture. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the predicate device. And the indications for use statement of the subject device has the same intended use as the primary predicate device to support prosthetic rehabilitation when used with dentalla or mandible to treat partially or fully edentulous patients.
– Indication for use, Material, Sterilization, Shelf Life, and Principle of Operation.
Differences 2.
The subject device has the different characteristic for the following compared to the predicate and reference devices.
- Widest Thread Diameter. Bevel Diameter. Total Length
The Widest Thread Diameter and length of subject device is slightly different with predicate device but all the dimensions of subject device lie within conbined range of predicate and reference devices. But the Midest Thread Diameter and length combinations of the subject device are not same to the predicate and reference is to provide a variety of implant dimensions because the size of the alveolar bone hole varies when a small implant fails. It does not affect substantial equivalence.
| Subject Device | Predicate/ Reference | Difference | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Model name | WidestThreadDiameter(Ø,mm) | BevelDiameter(Ø,mm) | TotalLength(mm) | Model name | WidestThreadDiameter(Ø,mm) | BevelDiameter(Ø,mm) | TotalLength(mm) | 510k | WidestThreadDiameter(Ø,mm) | BevelDiameter(Ø,mm) | Total Length(mm) |
| ARO5307 | 5.6 | 5.3 | 7 | ARO4807D | 5.5 | 4.8 | 7 | K182448 | Larger (0.1) | Larger (0.5) | same |
| ARO5308 | 5.6 | 5.3 | 7.7 | ARO4808D | 5.5 | 4.8 | 7.7 | K182448 | Larger (0.1) | Larger (0.5) | Same |
| ARO5310 | 5.6 | 5.3 | 9.2 | ARO4810D | 5.5 | 4.8 | 9.2 | K182448 | Larger (0.1) | Larger (0.5) | Same |
| ARO5311 | 5.6 | 5.3 | 10.7 | ARO4811D | 5.5 | 4.8 | 10.7 | K182448 | Larger (0.1) | Larger (0.5) | Same |
| ARO5313 | 5.6 | 5.3 | 12.2 | ARO4813D | 5.5 | 4.8 | 12.2 | K182448 | Larger (0.1) | Larger (0.5) | Same |
| ARO5315 | 5.6 | 5.3 | 14.2 | FANIHX5515 | 5.9 | 4.0 | 14.2 | K122231 | Smaller (0.3) | Larger (1.3) | Same |
| ARO5307D | 6 | 5.3 | 7 | RSWIR6007 | 6 | 5.0 | 7 | K063216 | Same | Larger (0.3) | Same |
| ARO5308D | 6 | 5.3 | 7.7 | RSWIR6008 | 6 | 5.0 | 8 | K063216 | Same | Larger (0.3) | Shorter (0.3) |
| ARO5310D | 6 | 5.3 | 9.2 | RSWIR6010 | 6 | 5.0 | 9.5 | K063216 | Same | Larger (0.3) | Shorter (0.3) |
| ARO5311D | 6 | 5.3 | 10.7 | RSWIR6011 | 6 | 5.0 | 11 | K063216 | Same | Larger (0.3) | Shorter (0.3) |
| ARO5313D | 6 | 5.3 | 12.2 | RSWIR6013 | 6 | 5.0 | 12.5 | K063216 | Same | Larger (0.3) | Shorter (0.3) |
| ARO5315D | 6 | 5.3 | 14.2 | FALIHX6015 | 6.4 | 5.5 | 14.4 | K122231 | Smaller (0.4) | Smaller (0.2) | Shorter (0.2) |
| ARO5807D | 6.5 | 5.3 | 7 | RSWIR6507 | 6.5 | 5.5 | 7 | K063216 | Same | Smaller (0.2) | Same |
| ARO5808D | 6.5 | 5.3 | 7.7 | RSWIR6508 | 6.5 | 5.5 | 8 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO5810D | 6.5 | 5.3 | 9.2 | RSWIR6510 | 6.5 | 5.5 | 9.5 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO5811D | 6.5 | 5.3 | 10.7 | RSWIR6511 | 6.5 | 5.5 | 11 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO5813D | 6.5 | 5.3 | 12.2 | RSWIR6513 | 6.5 | 5.5 | 12.5 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO5815D | 6.5 | 5.3 | 14.2 | FALIHX6515 | 6.9 | 5.5 | 14.4 | K122231 | Smaller (0.4) | Smaller (0.2) | Shorter (0.2) |
| ARO6307D | 7 | 5.3 | 7 | RSWIR7007 | 7 | 5.5 | 7 | K063216 | Same | Smaller (0.2) | Same |
| ARO6308D | 7 | 5.3 | 7.7 | RSWIR7008 | 7 | 5.5 | 8 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO6310D | 7 | 5.3 | 9.2 | RSWIR7010 | 7 | 5.5 | 9.5 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO6311D | 7 | 5.3 | 10.7 | RSWIR7011 | 7 | 5.5 | 11 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO6313D | 7 | 5.3 | 12.2 | RSWIR7013 | 7 | 5.5 | 12.5 | K063216 | Same | Smaller (0.2) | Shorter (0.3) |
| ARO6315D | 7 | 5.3 | 14.2 | FALIHX7015 | 7.4 | 5.5 | 14.4 | K122231 | Smaller (0.4) | Smaller (0.2) | Shorter (0.2) |
Feature
The thread pitch of subject device is slightly different with predicate device but all the thread pitch of subject device lies within range of reference. Implant to Abutment Connection
The connection of subject device is different with predicate device but has same connection as the reference device.
- Surface treatment
The surface treatment of subject device is different with predicate device but has same surface treatment as the reference device.
3. Discussion
The proposed BLUEDIAMONDimplant have common in all the terms in the Widest Thread Diameter, Jength, feature, implant to abutment connection, and surface treatment. These differences are substantial equivalence. And the differences in the indications for use statement between the subject device, K063216, are only minor changes in wording and do not affect the intended use for demonstrating substantial equivalence. The fatigue test was performed on worst case to confirm the substantial equivalence according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment".
On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate device.
{8}------------------------------------------------
Abutment Screw
| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| 510k | Not yet | K063216 | K182448 | K192347 |
| Device Name | Abutment Screwfor BLUEDIAMONDIMPLANT System | Rescue Internal ImplantSystem | Abutment Screwfor BLUEDIAMOND IMPLANTSystem | Abutment Screwfor ST Internal Implant System |
| Manufacturer | MegaGen Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| indication foruse | The BLUEDIAMONDIMPLANT System isintended to besurgically placed in themaxillary ormandibular molar areasfor the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.These implants can beused where smallerimplants have failed. | The Rescue InternalImplant System isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, andoverdentures) inpartially or fullyedentulous individuals.These implants areintended to be usedwhere smaller implantshave failed. | Abutment Screw is used forsecuring the abutment to theendosseous implant. | The ST Internal Implant System isintended to be surgically placed inthe maxillary or mandibular archesfor the purpose providingprosthetic support for dentalrestorations (Crown, bridges, andoverdentures) in partially or fullyedentulous individuals.It is used to restore a patient'schewing function. Smaller implants(less than 6.0 mm) are dedicatedfor immediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region and are indicatedfor delayed loading. |
| Design | Image: Abutment Screw | Image: Rescue Internal Implant System | Image: Abutment Screw | Image: Abutment Screw |
| Diameter (Ø,mm) | 2.2 | 3.1 | 2.2 | 2.15, 2.35 |
| Total Length(mm) | 9.9 | 7.9 | 7.9 | 8.4, 10.2 |
| ConnectionInterface | Internal ConicalConnection | Internal ConicalConnection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6A1-4V ELI (ASTMF136-13) | Ti-6A1-4V ELI (ASTMF136-13) | Ti-6A1-4V ELI (ASTM F136-13) | Ti-6A1-4V ELI (ASTM F136-13) |
| SurfaceTreatment | Machined, Anodizing | Machined | Machined | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle ofOperation | The Abutment Screw isused for connectingFixture to Abutment orAbutment to Cylinder. | The Abutment Screw isused for connectingFixture to Abutment orAbutment to Cylinder. | The Abutment Screw is usedfor connecting Fixture toAbutment or Abutment toCylinder. | Abutment Screw is used forsecuring the abutment to theendosseous implant. |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the prior cleared reference device. Indication for use, Design, Diameter, Connection Interface, Material, Single Use and Sterilization and Principle of Operation.
2. Difference
-Total Length
The Total Length of subject device is slightly different with the prior cleared reference device but all the dimensions of subject device lie within combined range of the prior cleared reference devices.
The subject device compared with the prior cleared reference device(K182448), the length of the Driver is fastened is increased to aid in fastening by the Hand Driver. There is no significant difference in product performance and the difference does not affect substantial equivalence.
3. Discussion
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the prior cleared reference device.
{9}------------------------------------------------
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 BLUEDIAMOND IMPLANT and Abutment Screw have the same material composition, manufacturing process and patient contacting parts as the previously cleared devices, XPEED AnyRidge Internal System (K122231) 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 Abutments – Guidance for Industry and FDA Staff".
The BLUEDIAMOND IMPLANT has same surface treatment and manufacturing process as the previously cleared device, AnyRidge Octa 1 Fixture (K182448) for the surface treatment of S.L.A(Fixtures).
The Abutment Screw has same surface treatment and manufacturing process as the previously cleared device, Abutment Screw for ST Internal Implant System(K192347). The purpose of Anodizing for Abutment Screw is to distinguish the connection type of screw body with the naked eyes for convenience. And It doesn't affect device's fundamental functions, safety and effectiveness.
Pyrogen and Endotoxin Test
The subject device will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39 <85>.
Sterilization validation and Shelf life
For the Implants (provided sterile), sterilization testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10%). Validation Testing was conducted per FDA Guidance: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life.
For the Abutment Screws (provided non-sterilization validation has been performed in accordance with the requirements of ISO 17665-1, ISO 17665-2 and FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Validation Testing was conducted on a worst-case test article from our prior predicate device submission, K220562.
Performance test
This subject device has similar design and same indication for use, principle of operation, technical characteristics and function except for Widest Thread Diameter and Total length. According to the diagram for determining the worst-case conditions of Annex B of ISO 14801, devices that had already been submitted in advance have already been selected as the worst-case scenario. Therefore, the Widest Thread Diameter of subject device is larger compared with the previously cleared device (K182448), it doesn't affect the performance change of the product.
{10}------------------------------------------------
MR Compatibility
Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
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 BLUEDIAMOND IMPLANT and Abutment Screw are substantially equivalent to the predicate device as here.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.