(140 days)
No
The 510(k) summary describes a standard dental implant system and does not mention any AI or ML components, image processing, or data sets for training or testing algorithms.
Yes
The device is described as an "Internal Implant System" and is composed of "dental fixtures" designed for "dental implant surgery" to replace missing teeth. This clearly indicates a therapeutic purpose.
No
The device description indicates it is an implant system (fixtures, abutments, and surgical instruments) used for dental implant surgery, not for diagnosing conditions.
No
The device description explicitly states it is composed of physical components: dental fixtures, abutments, and surgical instruments made of CP Ti Grade 4. It also mentions surface treatment and sterilization, which are processes applied to physical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MiNi Internal Implant System is a dental implant system composed of fixtures, abutments, and surgical instruments. These are physical devices implanted into the jawbone.
- Intended Use: The intended use is for replacing missing teeth through surgical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro testing. The performance studies focus on sterilization and fatigue testing of the physical implant, not on the accuracy or reliability of diagnostic measurements.
Therefore, the MiNi Internal Implant System is a surgical dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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. -
Product codes
DZE, NHA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors and mandibular incisors, extraction sites, alveolar ridge
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)
- Study Type: Non-Clinical Test Data (Fatigue Test, Sterility Test)
- Sample Size: Not explicitly stated for each test, but performed on the subject device.
- Key Results:
- Sterilization validating testing was performed in accordance with ISO 11137-1, ISO 11137-2, 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
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 (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
2
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)
3
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.
4
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 Internal | |||
| Implant System | OsseoSpeed™ Plus | XPEED AnyRidge | ||
| Internal Implant | ||||
| System | ||||
| Manufacturer | Megagen Implant Co., | |||
| Ltd. | Astra Tech AB | Megagen Implant Co., | ||
| Ltd. | ||||
| 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 | Implants: | |||
| The Astra Tech Dental | ||||
| Implants are intended for | ||||
| both one- and two-stage | ||||
| surgical procedures in the | ||||
| following situations and | ||||
| with the following clinical | ||||
| protocols: | ||||
| • replacing single and | ||||
| multiple missing teeth in the | ||||
| mandible and maxilla, | ||||
| • immediate placement in | ||||
| extraction sites and in | 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 a patient's chewing | ||||
| function. Smaller implants | ||||
| (less than Ø6.0 mm) are | ||||
| dedicated for immediate | ||||
| Indications for Use | ||||
| (continued) | situations with a partially or | |||
| completely healed alveolar | ||||
| ridge. | ||||
| • It is intended for delayed | ||||
| loading. | completely healed alveolar | |||
| ridge, | ||||
| • especially indicated for use | ||||
| in soft bone applications | ||||
| where implants with other | ||||
| implant surface treatments | ||||
| may be less effective, | ||||
| • immediate loading in all | ||||
| indications, except in single | ||||
| tooth situations on implants | ||||
| shorter than 8 mm or in soft | 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. | ||||
| bone (type IV) where | ||||
| implant stability may be | ||||
| difficult to obtain and | ||||
| immediate loading may not | ||||
| be appropriate. | ||||
| The intended use for | ||||
| OsseoSpeed™ Plus 3.0S is | ||||
| limited to replacement of | ||||
| maxillary lateral incisors and | ||||
| mandibular incisors. | ||||
| Abutments: | ||||
| Astra Tech Implant System | ||||
| Plus abutments are intended | ||||
| to be used in conjunction | ||||
| with Astra Tech Implant | ||||
| System Plus in fully | ||||
| edentulous or partially | ||||
| edentulous maxillary and/or | ||||
| mandibular arches to | ||||
| provide support for crowns, | ||||
| bridges or overdentures. | ||||
| Atlantis Abutments: | ||||
| The Atlantis™ Abutment is | ||||
| intended for use with an | ||||
| endosseous implant to | ||||
| support a prosthetic device | ||||
| in a partially or completely | ||||
| edentulous patient. It is | ||||
| intended for use to support | ||||
| single and multiple tooth | ||||
| prostheses, in the mandible | ||||
| or maxilla. The prosthesis | ||||
| can be cemented, screw | ||||
| retained or friction fit to the | ||||
| abutment. The abutment | ||||
| screw is intended to secure | ||||
| the abutment to the | ||||
| endosseous implant. | ||||
| The Atlantis™ Crown | ||||
| Abutment in Zirconia is | ||||
| intended for use with an | ||||
| endosseous implant to | ||||
| function as a substructure | ||||
| that also serves as the final | ||||
| restoration, in partially or | ||||
| completely edentulous | ||||
| patients. The prosthesis is | ||||
| screw retained. The | ||||
| abutment screw is intended | ||||
| to secure the crown | ||||
| abutment to the endosseous | ||||
| implant. | ||||
| 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 abutments | |||
| Internal 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 incisor
Internal 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 abutments
Internal 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 type
4.0 ~ 8.4mm |
| Fixture Height | | Internal Type:
8.0, 9.5, 11.0, 12.5
14.5mm | 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 Angled
abutments | | 15° | 15° ~ 30° | 15°, 25° |
| Product Code | | DZE, NHA | DZE, NHA | DZE, NHA |
| Surface Treatment | | Sand-blasted, Large
grit, Acid-etched
(S.L.A) | Resorbable Blasting
Media (R.B.M)
and fluoride coating | Sand-blasted, Large
grit, Acid-etched
(S.L.A) |
5
6
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,
7
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 test | |
| on the subject device | Fatigue Test |
| Sterility test | |
| Not conducted test | |
| on the subject device | Biocompatibility test: |
| Cytotoxicity | |
| Sensitization | |
| Irritation or Intracutaneous reactivity | |
| Systemic toxicity | |
| Sub-chronic Toxicity | |
| Genotoxocity | |
| Implantation | |
| Surface Analysis | |
| Residue 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.