(175 days)
No
The 510(k) summary describes a physical dental implant made of titanium. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and MR compatibility.
No.
The device is described as a dental implant system intended for prosthetic support and restoring chewing function, which is a restorative rather than a therapeutic function.
No
This device is a dental implant intended for prosthetic support and restoring chewing function, not for diagnosing medical conditions.
No
The device description clearly states it is a dental implant body system made of CP Ti Grade 4, which is a physical hardware component. The summary also details dimensions, materials, and physical testing (fatigue, pullout, MR compatibility).
Based on the provided text, the BLUEDIAMOND IMPLANT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is surgically placed in the body to provide prosthetic support for dental restorations and restore chewing function. This is a direct therapeutic and restorative function within the patient's body.
- Device Description: The description details a physical implant made of titanium, designed for surgical implantation into bone.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The BLUEDIAMOND IMPLANT is an implantable medical device used within the body for structural support and restoration.
N/A
Intended Use / Indications for Use
The BLUEDIAMOND IMPLANT 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 in the following situations and with the clinical protocols:
- Delayed loading
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
It is specifically recommended for:
- Fixed partial dentures/splinted units (one implant per unit)
- Pontic cases in combination with at least one longer implant
- Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
Product codes
DZE
Device Description
The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part. The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
Device: BLUEDIAMOND IMPLANT
Cuff Type: N/A
Description: The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):
- Normal Thread
Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0)
Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) - Deep Thread
Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Diameter X Total Length (Thread Length)
- Normal Thread
Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0) - Deep Thread
Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Implanted Length (Thread to Shoulder Height)
2.0, 3.0, 4.0
Gingival (Cuff) Height
The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.
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)
Biocompatibility: Evaluation performed in accordance with International Standard ISO 10993-1. No additional biocompatibility testing required as the device has same material composition, manufacturing process and patient contacting parts as previously cleared devices (K122231, K182448, K110955).
Pyrogen and Endotoxin Test: Endotoxin testing will be conducted on every batch with a testing limit of below 0.5 EU/mL in accordance with USP 39 . Device will not be labeled as "non-pyrogenic".
Sterilization validation and Shelf life: Sterilization validating testing performed in accordance with ISO 11137 to verify sterility assurance level (10^-6). Shelf life of 5 years validated using accelerated aging method in accordance with ASTM F1980. Subject device evaluated with previous device (K122231).
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". Same surface and manufacturing process as previously cleared devices (K122231).
Performance test: Fatigue tests performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment". Test results met pre-set criteria. Surface area analysis and pullout testing performed on 5 mm threaded length implants and compared to predicates.
MR Compatibility: Assessment performed to demonstrate that the subject devices do not configure a new worst case and can be represented by previously conducted studies reviewed for reference devices obtained the status of MR Conditional per K230618. Subject devices are MR conditional devices and can be safely scanned observing parameters previously established.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K182448, K210852, K230618, K202942, K213599, K200586, K122231, K192614, K210161, K203808, K233450, K110955
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 27, 2024
Megagen Implant Co. Ltd Hyo-Eun Lee 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA
Re: K241972
Trade/Device Name: BLUEDIAMOND IMPLANT Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 26, 2024 Received: November 27, 2024
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
BLUEDIAMOND IMPLANT
Indications for Use (Describe)
The BLUEDIAMOND IMPLANT 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 in the following situations and with the clinical protocols:
- Delaved loading
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
It is specifically recommended for:
-
Fixed partial dentures/splinted units (one implant per unit)
-
Pontic cases in combination with at least one longer implant
-
Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
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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4
510(k) Summary For BLUEDIAMOND IMPLANT (K241972)
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date Prepared: December 26, 2024
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: +82-53-289-3414 Email: ra7@imegagen.com
3. Device
| • Trade Name: | BLUEDIAMOND IMPLANT |
|---|---|
| --------------- | --------------------- |
- Endosseous Dental Implant . Common Name:
- Implant, Endosseous, Root-Form • Classification Name:
- 872.3640 Classification Regulation:
- DZE • Primary Product Code:
4. Predicate Device
.
• Primary Predicate Device:
K231967 - ARi ExCon Implant System
•Reference Device:
K182448 - BLUEDIAMOND IMPLANT System
- K210852 Noris Medical Dental Implants System Cortical
- K230618 MegaGen Dental Implant Systems Portfolio MR Conditional
- K202942 Straumann® 4 mm Short Implants, Straumann USA, LLC
- K213599 SuperLine, Dentium Co., Ltd.
K200586 - Straumann® TLX Implant System, Straumann USA, LLC
- K122231 Xpeed AnyRidge Internal Implant System
- K192614 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
- K210161 AnyOne Onestage Implant System
- K203808 Multi-unit Abutment, Multi-unit Angled Abutment
- K233450 MegaGen Dental Implant Abutment Scan Healing Abutment; Temporary
- Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment;
5
Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
5. Description
- י The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
- The BLUEDIAMOND IMPLANT is consisted of the following components. '
| Device | Content | ||
|---|---|---|---|
| BLUEDIAMOND | |||
| ND IMPLANT | Cuff Type | Description | The BLUEDIAMOND IMPLANT is a dental implant body system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function. |
| Material | CP Ti Grade 4 of ASTM F67 | ||
| Dimension | |||
| (mm) | - Normal Thread | ||
| Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0) | |||
| Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) | |||
| Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) |
-
Deep Thread
Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0) |
| | | | |
| | | | |
| | | | - Normal Thread
Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0) -
Deep Thread
Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0) |
| | | | 2.0, 3.0, 4.0 |
| | | Diameter X
Total Length
(Thread Length) | Implanted Length
(Thread to Shoulder Height)
Gingival (Cuff) Height | -
י The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.
6. Indication for use
The BLUEDIAMOND IMPLANT 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 in the following situations and with the clinical protocols:
-
Delayed loading
-
Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where
6
a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
It is specifically recommended for:
-
Fixed partial dentures/splinted units (one implant per unit)
-
Pontic cases in combination with at least one longer implant
-
Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants
7
7. Basis for Substantial Equivalence
The BLUEDIAMOND IMPLANT is substantially equivalent to the predicate in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The subject of the subject device slightly differ from the predicate device however it is not affecting substantial equivalence.
Based on the technological characteristic comparison tables provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.
Image /page/7/Figure/3 description: The image shows diagrams of different dental implants with labels and measurements. There are seven different implants shown, each with a different design and labeled with a code such as K231967 or K200586. The implants are labeled with names such as ARi ExCon Implant, BLUEDIAMOND IMPLANT, Noris Medical Dental Implants System -Cortical, Straumann® 4 mm Short Implants, SuperLine -FXSxxxx Series, and Straumann® TLX Implant System. The diagrams include measurements such as L1, L2, L3, and D1, indicating the length and diameter of different parts of the implants.
Dimensions of the implant (Subject and Predicate/references)
| | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | Reference Device 5 | | For the BLUEDIAMOND IMPLANTS
with a Thread Length of 5mm,
It is indicated for fixed or removable
reconstruction in situations of
moderate to severely atrophic
jawbone and with adequate bone
quality that allows primary stability
after implant insertion, where a
longer implant cannot be placed due
to limited vertical bone height. The
recommended healing time before
loading is between 10 to 12 weeks.
It is specifically recommended for:
- Fixed partial dentures/splinted units
(one implant per unit) - Pontic cases in combination with at
least one longer implant - Fully edentulous cases with at least
one 5 mm Short Implant in
combination with 2 longer implants in
the anterior region and at least four
total implants | achieved and with appropriate
occlusal loading. | Lager implats are dedicated for the molar
region. | | - Fixed partial
dentures/splinted units (one
implant per unit) - Pontic cases in combination
with at least one longer
implant - Fully edentulous cases with
at least one 4 mm Short
Implant in combination with 2
longer implants in the anterior
region and at least four total
implants | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K241972 | K231967 | K182448 | K210852 | K202942 | K213599 | K200586 | Design | | | | | | | |
| Device
Name | BLUEDIAMOND IMPLANT | ARi ExCon Implant | BLUEDIAMOND IMPLANT | Noris Medical Dental Implants
System -Cortical | Straumann® 4 mm Short
Implants | SuperLine -FXSxxxx Series | Straumann® TLX Implant System | Widest
Thread
Diameter
(D1, mm)
×
Total
Length (L3,
mm) | · Normal Thread
Ø 4.0 × 9.0, 11.0, 13.0, 15.0
Ø 4.4 × 7.0, 9.0, 11.0, 13.0, 15.0
Ø 4.7 × 7.0, 9.0, 11.0, 13.0, 15.0
· Deep Thread
Ø 4.4 × 9.0, 11.0, 13.0, 15.0
Ø 4.8 × 7.0, 9.0, 11.0, 13.0, 15.0
Ø 5.1 × 7.0, 9.0, 11.0, 13.0, 15.0 | · Normal Thread
Ø 3.8 × 11.0, 13.0, 15.0
Ø 4.3 × 11.0, 13.0, 15.0
Ø 4.8 × 11.0, 13.0, 15.0
Ø 5.3 × 11.0, 13.0, 15.0
· Deep Thread
Ø 4.3 × 11.0, 13.0, 15.0
Ø 4.8 × 11.0, 13.0, 15.0
Ø 5.3 × 11.0, 13.0, 15.0
Ø 5.8 × 11.0, 13.0, 15.0 | · Normal thread
Ø3.6 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.0 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.4 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.7 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.0 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
· Deep thread
Ø4.0 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.4 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø4.8 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.0 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2
Ø5.5 × 7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | Ø4.0 × 11.5, 13.0, 16.0, 18.0, 20.0
Ø5.0 × 11.5, 13.0, 16.0
Ø6.0 × 11.5, 13.0, 16.0 | Ø4.1 × 5.8*
Ø4.8 x 5.8* | Ø3.6 x 7.0
Ø4.0 x 7.0
Ø4.5 x 7.0
Ø5.0 x 7.0
Ø5.0 x 7.0
Ø5.8 x 7.0 | Ø 3.75 × 7.8, 8.8, 11.8, 13.8, 15.8, 17.8, 19.8*
Ø 4.0 × 7.8, 8.8, 11.8, 13.8, 15.8, 17.8, 19.8*
Ø 4.5 × 7.8, 8.8, 11.8, 13.8, 15.8, 17.8, 19.8*
Ø 5.0 × 7.8, 8.8, 11.8, 13.8, 15.8, 17.8, 19.8*
Ø 5.5 × 7.8, 8.8, 11.8, 13.8*
Ø 6.5 × 7.8, 8.8, 11.8, 13.8* |
| Manufactu
rer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Noris Medical LTD | Straumann USA, LLC | Dentium Co., Ltd. | Straumann USA, LLC | Threaded
Length
(L1, mm) | · Normal Thread
Ø 4.0: 7.0, 9.0
Ø 4.4: 5.0, 7.0, 9.0
Ø 4.7: 5.0, 7.0, 9.0
· Deep Thread
Ø 4.4: 7.0, 9.0
Ø 4.8: 5.0, 7.0, 9.0
Ø 5.1: 5.0, 7.0, 9.0 | For all diameters:
7.0, 9.0 | For all diameters:
7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | Ø 4.0: 6.8, 8.0, 10.0, 11.0, 12.5
Ø 5.0: 6.8, 8.0, 10.0
Ø 6.0: 6.8, 8.0, 10.0 | For all diameters:
4.0 | For all diameters:
5.5 | Ø 3.75: 5.0, 7.0, 8.3, 10.3, 12.3, 14.0, 16.0*
Ø 4.0: 5.0, 7.0, 8.3, 10.3, 12.3, 14.0, 16.0*
Ø 4.5: 5.0, 7.0, 8.3, 10.3, 12.3, 14.0, 16.0*
Ø 5.0: 5.0, 7.0, 8.3, 10.3, 12.3, 14.0, 16.0*
Ø 5.5: 5.0, 7.0, 8.3, 10.3*
Ø 6.5: 5.0, 7.0, 8.3, 10.3* |
| Indication
for use | The BLUEDIAMOND IMPLANT 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 in the
following situations and with the
clinical protocols: - Delayed loading
- Immediate loading when good
primary stability is achieved and with
appropriate occlusal loading. | The ARi ExCon 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 in the
following situations and with
the clinical protocols: - Delayed loading
- Immediate loading when
good primary stability is | The BLUEDIAMOND 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. | Noris Medical Dental Implants
System is intended to replace
missing tooth/teeth in either jaw for
supporting prosthetic devices that
may aid in restoring the patient's
chewing function. The procedure
can be accomplished in a one-stage
or two-stage surgical operation. All
implants are appropriate for
immediate loading when good
primary stability is achieved and
with appropriate occlusal loading. | Straumann® 4 mm Short
Implants are indicated for
fixed or removable
reconstruction in situations of
moderate to severely atrophic
jawbone and with adequate
bone quality that allows
primary stability after implant
insertion, where a longer
implant cannot be placed due
to limited vertical bone height.
The recommended healing
time before loading is
between 10 to 12 weeks.
The 4 mm Short Implants are
specifically recommended for: | SuperLine® implants are
indicated for use in surgical and
restorative applications for
placement in the bone of the
upper or lower jaw to provide
support for prosthetic devices,
such as artificial teeth, in order to
restore the patient's chewing
function. SuperLine® implants
are indicated also for immediate
loading when good primary
stability is achieved and with
appropriate occlusal loading.
Single tooth cases on 7 mm
length implants are indicated for
delayed loading. | TLX Dental Implant:
Straumann TLX Implants are suitable for
endosteal implantation in the upper and lower
jaws and for the functional and esthetic oral
rehabilitation of edentulous and partially
edentulous patients. TLX Implants can be placed
with immediate function on single-tooth and
multi-unit restorations when good primary
stability is achieved and with appropriate
occlusal loading to restore chewing function.
The prosthetic restorations are connected to
the implants through the corresponding
abutment components. | Implanted
Length
(L2, mm)
(Length
within the
bone) | · Normal Thread
Ø 4.0: 8.0, 9.0, 10.0, 11.0
Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0
Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0
· Deep Thread
Ø 4.4: 8.0, 9.0, 10.0, 11.0
Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0
Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 | For all diameters:
8.0, 9.0, 10.0, 11.0 | For all diameters:
7.0, 7.7, 9.2, 10.7, 12.2, 14.2, 17.2 | Ø 4.0: 7.5, 9.0, 12.0,14.0, 16.0
Ø 5.0: 7.5, 9.0, 12.0
Ø 6.0: 7.5, 9.0, 12.0 | For all diameters:
4.0 | For all diameters:
5.5 | Ø3.75, Ø4.0, Ø4.5, Ø5.0:
6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0
Ø5.5, Ø6.5: 6.0, 8.0, 10.0, 12.0 |
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| Gingival
(Cuff)
Height
(L3-L2,
| mm) | 2.0, 3.0, 4.0 | 3.0, 4.0 | N/A | 4.0 | 1.8* | 1.5 | 1.8* |
|---|---|---|---|---|---|---|---|
| Thread to | |||||||
| Shoulder | |||||||
| Height | |||||||
| (L2-L1, | |||||||
| mm) | 1.0, 2.0 | 1.0, 2.0 | N/A | 0.7, 1.0, 2.0, 3.0, 3.5 | N/A | N/A | 1.0, 1.7, 2.0* |
| Implant to | |||||||
| Abutment | |||||||
| Connection | Internal Octa | External Hex | Internal Octa | Internal Hex | Internal | Tapered conical hex | TorcFit |
| (with conical fitting) | |||||||
| Material | CP Ti Grade 4 | ||||||
| (ASTM F67) | CP Ti Grade 4 | ||||||
| (ASTM F67) | CP Ti Grade 4 | ||||||
| (ASTM F67) | Titanium alloy | Roxolid® (Ti-Zr alloy) | All implants: unalloyed | ||||
| titanium, ASTM F67 | Titanium Grade 4 | ||||||
| Surface | |||||||
| Treatment | Sand-blasted, Large grit, Acid- | ||||||
| etched (S.L.A) | |||||||
| Machined collar | Sand-blasted, Large grit, | ||||||
| Acid-etched (S.L.A) | |||||||
| Machined collar | Sand-blasted, Large grit, Acid- | ||||||
| etched (S.L.A) | RBM (Resorbable Balsting | ||||||
| Media) | SLActive® | All implants: S.L.A., Al2O3 | |||||
| blasted and acid etched | Hydrophilic SLActive® | ||||||
| Sterilizatio | |||||||
| n | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation | Sterile - irradiation |
| Shelf Life | 5 Years | 5 Years | 5 Years | 5 Years | 5 Years | Unknown | 5 Years |
| Type | Tissue level Implant | Tissue level Implant | Bone level Implant | Tissue level Implant | Tissue level Implant | Tissue level Implant | Tissue level Implant |
| Feature | - Tapered body |
- 0.8mm thread pitch | - Tapered body
- 0.8mm thread pitch | - Submerged implant
- Tapered body
- cutting edge with self-tapping
- 0.8mm thread pitch | - Tapered body
- Threaded | | | |
- Dimensional information not found in the 510(k) Summary for each reference device was taken from the published catalog for that device.
Substantial Equivalence Discussion
1. Similarities
The subject device has the same characteristic for the followings compared to the Predicate device.
- Indication for Use, Design, Thread to shoulder Height, Implant to Abutment Connection, Material, Surface, Type and Feature.
2. Differences
The subject device has the different characteristic for the followings compared to the Predicate device.
- Widest Thread Diameter, Total Length
The Widest Thread Diameter and Total Levice is slightly different with predicate device but all the dimensions of subject device lie within rage of predicate device.
- Threaded Length
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The Threaded Length of subject device is slightly different with predicate device lie within range of Predicate/Reference devices.
- Implanted Length
The Implanted Length of subject device is slight predicate device. But, all dimensions of subject device lie within range of Predicate/Reference devices.
- Gingival (Cuff) Height
The Gingival (Cuff) Height of subject device is slight predicate device. But, all dimensions of subject device lie within range of Predicatel Reference devices, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition.
3. Discussion
The proposed Cuff type of BLUEDIAMOND INPLANT has common in all the terms in the Widest Thread Diameter, Total Length, Threaded Length, Implanted Length and Gingival (Cuff) Height. But all dimensions of Predicate/Reference devices. Therefore, these differences don't affect the device's fundamental functions, safety and effectiveness
The fatigue test was performed on worst case to confirm the substantial equivalence according to "SO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment".
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8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Biocompatibility
The biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The additional biocompatibility testing is not required on the BLUEDIAMOND IMPLANT system since the BLUEDIAMOND IMPLANT system has same material composition, manufacturing process and patient contacting parts as the previously cleared device, XPEED AnyRidge Internal System (K122231), BLUEDIAMOND Implant System (K182448) and AnyRidge Internal Implant System (K110955).
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
The BLUEDIAMOND IMPLANT is supplied in sterile state. Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10°). 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. The subject device is evaluated with previous device which was evaluated under the previous 510(k) submission, K122231. Also, the following guidance documents were referred to:
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
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 and manufacturing process with the previously our cleared devices of XPEED AnyRidge Internal System (K122231) for the surface treatment of S.L.A.
Performance test
The Fatigue tests have been performed in accordance with "ISO 14801" and "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.
The surface area analysis and pullout testing were performed on the subject 5 mm threaded length implants, and compared to predicates.
MR Compatibility
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices according to FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for reference devices obtained the status of MR Conditional per K230618. Therefore, the subject devices are MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per reference devices.
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9. Conclusion
Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the subject device is substantially equivalent to the predicate and reference devices.