(140 days)
The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading.
MiNi Internal Implant System is composed of MiNi Internal Fixtures, abutments, and surgical instruments. The dental fixtures are made of CP Ti Grade 4 designed for use in dental implant surgery. This system is used as two stage surgery, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options. The fixtures are available in diameters of 3.0mm, 3.4mm and lengths of 8.0mm, 9.5mm, 11.0mm, 12.5mm, and 14.5mm. The fixtures, abutments, and surgical instruments are produced and packaged separately. The Surface treatment for this device is S.L.A (Sand-blasted, Large grit, Acid-etched). This system includes various abutments, such as Abutment Screw, Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling Abutment, Solid Abutment, Temporary Abutment, Impression Coping, Plastic Impression Coping, Guide Pin, Lab Analog, and Meg-Rhein Abutment. These abutments are compatible with MiNi Internal Fixtures.
This document pertains to the 510(k) premarket notification for the "MiNi Internal Implant System" by MegaGen Implant Co., Ltd. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device itself.
Based on the provided text, the device is an endosseous dental implant, and the 510(k) submission primarily relies on comparing its design, materials, and intended use to a legally marketed predicate device (OsseoSpeed™ Plus, K120414) and a reference predicate device (XPEED AnyRidge Internal Implant System, K140091).
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's performance in a clinical study in the way one might expect for a standalone AI/medical device. Instead, it relies on demonstrating that the device meets existing standards and is substantially equivalent to predicate devices. The "reported device performance" is primarily in relation to meeting these standards through non-clinical testing.
| Acceptance Criteria (Implicit from testing standards) | Reported Device Performance |
|---|---|
| Sterilization: SAL (Sterility Assurance Level) of 10^-6 (per ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, ISO 11737-2 for gamma sterilization, and ISO 17665-1, ISO 17665-2 for steam sterilization) | Test results demonstrated that the SAL of 10^-6 was achieved, and all testing requirements were met for both gamma and steam sterilization. |
| Dynamic Fatigue: Meet criteria of ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), following FDA guidance for "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | The fatigue test was performed on the subject device. The results of the non-clinical testing demonstrate that the results have met the criteria of the standards. (Specific numerical performance metrics for fatigue strength are not provided in this summary, but the general statement indicates compliance). |
| Biocompatibility: Meet requirements for cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, sub-chronic toxicity, genotoxicity, implantation (based on material and surface properties). | Biocompatibility tests were not conducted on the subject device. The rationale is that the subject device has the same material (CP Ti Grade 4), surface treatment (S.L.A), and manufacturing process as the reference predicate device (K140091), for which these tests were presumably previously conducted and met. |
| Surface Analysis: (to ensure consistency with predicate) | Surface analysis was not conducted on the subject device, using the same rationale as biocompatibility. |
| Residue Analysis: (to ensure consistency with predicate) | Residue analysis was not conducted on the subject device, using the same rationale as biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of a prospective study for the MiNi Internal Implant System. The testing described is non-clinical (sterilization and fatigue).
- Non-Clinical Testing: The sample sizes for the fatigue test and sterilization validation are not explicitly stated in this summary. These tests would involve a specific number of manufactured devices for destructive and non-destructive testing.
- Data Provenance: The manufacturing company, MegaGen Implant Co., Ltd., is located in Gyeongsan-si, Gyeongsangbuk-do, South Korea. The non-clinical testing would have been performed there or at associated testing facilities. This is a retrospective submission based on existing data and comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert-established ground truth on a test set (e.g., image interpretation). The evaluation is based on non-clinical engineering and material science standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication process described, as it's not a clinical or interpretive study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a dental implant, not an AI or imaging diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant), not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Sterilization: The ground truth is the established scientific and regulatory requirement for a Sterility Assurance Level (SAL) of 10^-6, as defined by ISO standards.
- Fatigue Test: The ground truth is the performance criteria outlined in the ISO 14801:2007 standard and the FDA guidance document for endosseous dental implants.
- Biocompatibility, Surface Analysis, Residue Analysis: The "ground truth" for the non-conducted tests is established by the identical material, surface treatment, and manufacturing process to the reference predicate device (K140091), implying that the prior testing of the predicate serves as the ground for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with a symbol resembling a caduceus above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
MegaGen Implant Co., Ltd c/o Ms. Megan Holden Kodent, Inc. 325 N. Puente St., Unit B Brea, California 92821
Re: K150537
Trade/Device Name: MiNi Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 16, 2015 Received: June 22, 2015
Dear Ms. Holden:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known): K150537
Device Name: MiNi Internal Implant System
Indications for Use:
The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading. -
X Prescription Use ____________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
(K150537)
This 510(k) Summary is being submitted in accordance with requirements of 21 CFR Part 807.92.
Submitter:
Dong Guk Ha MegaGen Implant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongsangbuk-do, South Korea Phone: 82-53-857-5770 82-53-857-5432 Fax:
Contact /US agent:
Megan Holden KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
Device Information:
Device Name: MiNi Internal Implant System Classification Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640 Date Prepared: 7/17/2015
General Description
MiNi Internal Implant System is composed of MiNi Internal Fixtures, abutments, and surgical instruments. The dental fixtures are made of CP Ti Grade 4 designed for use in dental implant surgery. This system is used as two stage surgery, root-form dental implants, associated with abutment systems, which provide the clinician with the screw and cement retained restoration for multi-mount options.
The fixtures are available in diameters of 3.0mm, 3.4mm and lengths of 8.0mm, 9.5mm, 11.0mm, 12.5mm, and 14.5mm. The fixtures, abutments, and surgical instruments are produced and packaged separately. The Surface treatment for this device is S.L.A (Sand-blasted, Large grit, Acid-etched).
This system includes various abutments, such as Abutment Screw, Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling Abutment, Solid Abutment, Temporary Abutment, Impression Coping, Plastic Impression Coping, Guide Pin, Lab Analog, and Meg-Rhein Abutment. These abutments are compatible with MiNi Internal Fixtures.
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Indication for use
The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:
- -The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.
- Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading. -
Predicate devices
- Primary Predicate Device : OsseoSpeed™ Plus (K120414) .
- Reference Predicate Device : XPEED AnyRidge Internal Implant System (K140091) .
Substantial Equivalence Comparison
The MiNi Internal Implant System is similar designs and dimensions, and has the same material, intended use, and technological characteristics as the identified primary predicate device (K120414). The MiNi Internal Implant System is similar in fundamental scientific technology, and has the same material, surface treatment to the reference predicate device (K140091). When compared with predicate device, no new questions of substantial equivalence have been raised for the MiNi Internal Implant System.
| Subject Device | Primary Predicate | Reference Predicate | ||
|---|---|---|---|---|
| Device | Device | |||
| 510(k) Number | K150537 | K120414 | K140091 | |
| Device Name | MiNi InternalImplant System | OsseoSpeed™ Plus | XPEED AnyRidgeInternal ImplantSystem | |
| Manufacturer | Megagen Implant Co.,Ltd. | Astra Tech AB | Megagen Implant Co.,Ltd. | |
| Indications for Use | The MiNi Internal ImplantSystem is intended for two-stage surgical procedures inthe following situations andwith the following clinicalprotocols:• The intended use for the3.0 mm diameter MiNiimplant is limited to thereplacement of maxillarylateral incisors andmandibular incisors.• Immediate placement inextraction sites and in | Implants:The Astra Tech DentalImplants are intended forboth one- and two-stagesurgical procedures in thefollowing situations andwith the following clinicalprotocols:• replacing single andmultiple missing teeth in themandible and maxilla,• immediate placement inextraction sites and in | The XPEED AnyRidgeInternal Implant System isintended to be surgicallyplaced in the maxillary ormandibular molar areas forthe purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) inpartially or fully edentulousindividuals. It is used torestore a patient's chewingfunction. Smaller implants(less than Ø6.0 mm) arededicated for immediate | |
| Indications for Use(continued) | situations with a partially orcompletely healed alveolarridge.• It is intended for delayedloading. | completely healed alveolarridge,• especially indicated for usein soft bone applicationswhere implants with otherimplant surface treatmentsmay be less effective,• immediate loading in allindications, except in singletooth situations on implantsshorter than 8 mm or in soft | loading when good primarystability is achieved and withappropriate occlusal loading.Larger implants arededicated for the molarregion and are indicated fordelayed loading. | |
| bone (type IV) whereimplant stability may bedifficult to obtain andimmediate loading may notbe appropriate.The intended use for | ||||
| OsseoSpeed™ Plus 3.0S islimited to replacement ofmaxillary lateral incisors andmandibular incisors.Abutments: | ||||
| Astra Tech Implant SystemPlus abutments are intendedto be used in conjunctionwith Astra Tech ImplantSystem Plus in fullyedentulous or partiallyedentulous maxillary and/ormandibular arches toprovide support for crowns, | ||||
| bridges or overdentures.Atlantis Abutments:The Atlantis™ Abutment isintended for use with anendosseous implant to | ||||
| support a prosthetic devicein a partially or completelyedentulous patient. It isintended for use to supportsingle and multiple toothprostheses, in the mandible | ||||
| or maxilla. The prosthesiscan be cemented, screwretained or friction fit to theabutment. The abutmentscrew is intended to securethe abutment to the | ||||
| endosseous implant.The Atlantis™ CrownAbutment in Zirconia isintended for use with anendosseous implant tofunction as a substructure | ||||
| that also serves as the finalrestoration, in partially orcompletely edentulouspatients. The prosthesis isscrew retained. Theabutment screw is intended | ||||
| to secure the crownabutment to the endosseousimplant. | ||||
| Design | MiNi Internal Implant System, abutments and accessories have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutmentsInternal Hex | -Single-stage or two-stage- Single-tooth and/or multiple tooth applications- OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisorInternal Double Hex | XPEED AnyRidge Internal Implant System, abutments and accessories have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutmentsInternal Hex | |
| Material | CP Ti Grade 4(ASTM F67) | CP Ti Grade 4(ASTM F67) | ||
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | |
| Fixture Diameter | Internal Type:Ø3.0, 3.4mm | Internal Type:Ø3.0, 3.5, 4.2, 4.8, 5.4mm | Internal type4.0 ~ 8.4mm | |
| Fixture Height | Internal Type:8.0, 9.5, 11.0, 12.514.5mm | Internal Type:6.0 – 17.0mm(6.0mm height excluded for Ø3.0, 4.2, 4.8mm and 17.0mm height excluded for Ø3.0, 5.4mm) | Internal type:7.7 ~ 14.4mm | |
| Abutment | Diameters | Ø3.0 ~ 3.5mm | Ø3.0 ~ 5.4mm | Ø4.0 ~ 10.0mm |
| Materials | Ti-6Al-4V ELI | Ti-6Al-4V ELI,CP Ti Grade 4 | ||
| Angulations of Angledabutments | 15° | 15° ~ 30° | 15°, 25° | |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | |
| Surface Treatment | Sand-blasted, Largegrit, Acid-etched(S.L.A) | Resorbable BlastingMedia (R.B.M)and fluoride coating | Sand-blasted, Largegrit, Acid-etched(S.L.A) |
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The differences in indications between the MiNi Internal Implant System and primary predicate device (K120414) do not raise new questions of substantial equivalence because they are selected as a subset of the primary predicate. The MiNi Internal Implant System removed the indications of one-stage surgery, immediate loading, and soft bone clinical use compared to the primary predicate (K120414). Thus, the proposed indications do not increase risk nor change the intended use of the device and are found to be substantially equivalent.
Non-Clinical Test Data
Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2,
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ISO 11137-3, ISO 11737-1, and ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met.
The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The worst case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device.
| Testing Item | |
|---|---|
| Conducted teston the subject device | Fatigue TestSterility test |
| Not conducted teston the subject device | Biocompatibility test:CytotoxicitySensitizationIrritation or Intracutaneous reactivitySystemic toxicitySub-chronic ToxicityGenotoxocityImplantationSurface AnalysisResidue Analysis |
Biocompatibility Test, surface analysis, and residue analysis have not been conducted because the subject device has the same material, surface treatment, and manufacturing process as the reference predicate device (K140091). There is no difference between the subject and predicate device. There is no additional testing conducted on the subject device.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Megagen Implant Co., Ltd. concludes that the MiNi Internal Implant system is substantially equivalent to predicate devices as described herein.
§ 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.