Who is the manufacturer of BLUEDIAMOND IMPLANT, Abutment Screw?

Megagen Implant Co., Ltd. filed the 510(k) submission for BLUEDIAMOND IMPLANT, Abutment Screw (K211812).

What is the FDA product code for BLUEDIAMOND IMPLANT, Abutment Screw?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for BLUEDIAMOND IMPLANT, Abutment Screw?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BLUEDIAMOND IMPLANT, Abutment Screw?

Rescue Internal Implant System (K063216).

Who can help prepare an FDA 510(k) submission like BLUEDIAMOND IMPLANT, Abutment Screw?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BLUEDIAMOND IMPLANT, Abutment Screw

K211812 · Megagen Implant Co., Ltd. · DZE · Jan 6, 2023 · Dental

Device Facts

Record ID	K211812
Device Name	BLUEDIAMOND IMPLANT, Abutment Screw
Applicant	Megagen Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Jan 6, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

BLUEDIAMOND IMPLANT system consists of endosseous dental implants and abutment screws. Implants are surgically placed in maxillary or mandibular molar areas to provide prosthetic support for dental restorations. Abutment screws secure abutments to implants. Implants are fabricated from CP Ti Grade 4; abutment screws from Ti-6Al-4V ELI. Implants feature SLA surface treatment; abutment screws are machined and anodized. Device is used by dental clinicians in clinical settings. Output is a stable foundation for dental prosthetics, enabling restoration of chewing function. Benefits include support for patients where smaller implants have failed. System is compatible with various MegaGen-cleared abutments and prostheses.

Clinical Evidence

No clinical studies were submitted. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), and shelf-life testing (ASTM F1980). MR compatibility was established via scientific rationale and published literature.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67) for implants; Ti-6Al-4V ELI (ASTM F136-13) for abutment screws. Surface: SLA (implants), Anodized (screws). Connection: Internal Conical/Octa. Sterilization: Gamma (implants), non-sterile (screws). Dimensions: Implants Ø 5.6-7.0mm, lengths 7.0-14.2mm; Screws Ø 2.2mm, length 9.9mm.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular molar areas, including cases where smaller implants have failed.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Rescue Internal Implant System (K063216)

Reference Devices

Xpeed AnyRidge Internal Implant System (K122231)
AnyRidge Octa 1 Implant System (K182448)
ST Internal Implant System (K192347)

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K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
K231100 — Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw · Proimtech Saglik Urunleri Anonim Sirketi · Aug 23, 2024

Submission Summary (Full Text)

{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 | 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…