(574 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties, sterilization, and mechanical testing.
No
This device is a dental implant system used for prosthetic support, which replaces missing body parts and restores function, rather than treating a disease or condition therapeutically.
No
The device is an implant system designed to provide prosthetic support for dental restorations. It is a structural component and not described as collecting or analyzing data to diagnose a condition.
No
The device description clearly states it is a physical dental implant system made of CP Ti Grade 4 and Ti-6AL-4V ELI, intended for surgical placement. It also details non-clinical testing related to biocompatibility, surface treatment, sterilization, shelf life, fatigue, and MR compatibility, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations." This describes a surgical implant used within the body, not a device used to examine specimens taken from the body.
- Device Description: The description details the materials and physical characteristics of a dental implant, which is a medical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular molar areas
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)
Non-Clinical Testing:
- Biocompatibility: Evaluation performed in accordance with ISO 10993-1. The device has the same material composition, manufacturing process, and patient contacting parts as previously cleared devices (K122231, K182448).
- Modified Surface Treatment: Evaluation 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 the same surface treatment and manufacturing process as K182448. The Abutment Screw has the same surface treatment and manufacturing process as K192347; anodizing is for visual distinction and does not affect fundamental functions, safety, or effectiveness.
- Pyrogen and Endotoxin Test: Endotoxin testing will be conducted on every batch with a limit below 0.5 EU/mL in accordance with USP 39 . The device will not be labeled as "non-pyrogenic".
- Sterilization validation and Shelf life:
- Implants (provided sterile): Sterilization testing performed in accordance with ISO 11137 for a sterility assurance level of 10^-6. Validation conducted per FDA Guidance: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."
- Shelf Life: Validated 5 years shelf life using the accelerated aging method in accordance to ASTM F1980.
- Abutment Screws (provided non-sterilization): Validation performed in accordance with ISO 17665-1, ISO 17665-2, and FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Validation conducted on a worst-case test article from K220562.
- Performance test: The device has similar design and same indication for use, principle of operation, technical characteristics, and function, except for Widest Thread Diameter and Total length. Fatigue test performed on worst case according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment." The larger Widest Thread Diameter of the subject device compared to K182448 does not affect product performance.
- MR Compatibility: Non-clinical worst-case MRI review 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 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.
Clinical Testing: No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
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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 | Fixture | ||
| Product | |||
| BLUEDIAMOND | |||
| IMPLANT | Description | The BLUEDIAMOND 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. These implants can be used where | |||
| smaller 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 | Abutment | ||
| Level | |||
| Prosthesis | |||
| Abutment Screw | Description | Abutment Screw is used for securing the abutment to the endosseous | |
| implant. | |||
| 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 Thread | ||||
| Diameter (mm) | Total Length | ||||
| (mm) | Fixture - Abutment | ||||
| Connection 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 Abutment | |||||
| Multi-unit Angled Abutment | |||||
| CCM Abutment | |||||
| Octa 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 Abutment | |||||
| Meg-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 | ||||
| (Compatible | ||||
| Implant System) | BLUEDIAMOND IMPLANT | Rescue Internal Implant | ||
| System | XPEED AnyRidge Internal Implant | |||
| System | AnyRidge Octa 1 Implant System | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| 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. | The Rescue Internal 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 are intended | ||||
| to be used where smaller | ||||
| implants have failed. | The Xpeed 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 | ||||
| patients 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 AnyRidge Octa 1 Implant System | |||
| is intended to be surgically placed in | ||||
| the maxillary or mandibular molar | ||||
| arches 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 in | ||||
| 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. |
| Design | | | | |
| Widest Thread
Diameter
(Ø, mm) & Total
Length
(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 to
Abutment
Connection | 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) |
| Surface
Treatment | 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 of | ||||
| Operation | This product is dental implant | |||
| which is inserted in the alveolar | ||||
| bone. It replaces the functions of | ||||
| the missing teeth as a dental | ||||
| implant fixture. | This product is dental implant | |||
| which is inserted in | ||||
| the alveolar bone. It replaces | ||||
| the functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | This product is dental implant | |||
| which is inserted in the alveolar | ||||
| bone. It replaces the functions of | ||||
| the missing teeth as a dental | ||||
| implant fixture. | This product is dental implant which | |||
| is inserted in the alveolar bone. It | ||||
| replaces the functions of the missing | ||||
| teeth 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 | Widest | ||||||||||
| Thread | |||||||||||
| Diameter | |||||||||||
| (Ø,mm) | Bevel | ||||||||||
| Diameter | |||||||||||
| (Ø,mm) | Total | ||||||||||
| Length | |||||||||||
| (mm) | Model name | Widest | |||||||||
| Thread | |||||||||||
| Diameter | |||||||||||
| (Ø,mm) | Bevel | ||||||||||
| Diameter | |||||||||||
| (Ø,mm) | Total | ||||||||||
| Length | |||||||||||
| (mm) | 510k | Widest | |||||||||
| Thread | |||||||||||
| Diameter | |||||||||||
| (Ø,mm) | Bevel | ||||||||||
| Diameter | |||||||||||
| (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 Screw | |||
| for BLUEDIAMOND | ||||
| IMPLANT System | Rescue Internal Implant | |||
| System | Abutment Screw | |||
| for BLUEDIAMOND IMPLANT | ||||
| System | Abutment Screw | |||
| for ST Internal Implant System | ||||
| Manufacturer | MegaGen Implant Co., | |||
| Ltd. | MegaGen Implant Co., | |||
| Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | ||
| 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. | The Rescue Internal | |||
| 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 are | ||||
| intended to be used | ||||
| where smaller implants | ||||
| have failed. | Abutment Screw is used for | |||
| securing the abutment to the | ||||
| endosseous implant. | The ST Internal Implant System 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. | ||||
| 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: 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 |
| Connection | ||||
| Interface | Internal Conical | |||
| Connection | Internal Conical | |||
| Connection | Internal Conical Connection | Internal Conical Connection | ||
| Material | Ti-6A1-4V ELI (ASTM | |||
| F136-13) | Ti-6A1-4V ELI (ASTM | |||
| F136-13) | Ti-6A1-4V ELI (ASTM F136-13) | Ti-6A1-4V ELI (ASTM F136-13) | ||
| Surface | ||||
| Treatment | Machined, Anodizing | Machined | Machined | Anodizing |
| Single Use | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Principle of | ||||
| Operation | The Abutment Screw is | |||
| used for connecting | ||||
| Fixture to Abutment or | ||||
| Abutment to Cylinder. | The Abutment Screw is | |||
| used for connecting | ||||
| Fixture to Abutment or | ||||
| Abutment to Cylinder. | The Abutment Screw is used | |||
| for connecting Fixture to | ||||
| Abutment or Abutment to | ||||
| Cylinder. | Abutment Screw is used for | |||
| securing the abutment to the | ||||
| endosseous 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 .
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.