(162 days)
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The system offers the following components. - Comfort Cap
This document describes a 510(k) premarket notification for the "Advanced Intermezzo Implant System," an endosseous dental implant. The purpose of the 510(k) summary is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one might expect for a typical performance study of a diagnostic device. Instead, the focus is on demonstrating "substantial equivalence" to predicate devices through various tests.
The primary method for demonstrating substantial equivalence related to performance was a comparative fatigue test.
While specific numerical acceptance criteria (e.g., minimum force for fatigue failure) are not provided, the reported device performance is that the subject device met the performance of the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence via Fatigue Test) | Reported Device Performance (Summary) |
|---|---|
| To demonstrate "substantial equivalence" in fatigue performance compared to the predicate device per ISO 14801. | The test result of the fatigue test supported that the subject device is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fatigue Testing: The document does not specify the exact sample size used for the comparative fatigue test per ISO 14801. It only states that the test was "conducted on the subject device and primary predicate."
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin for the test data. However, the submitting company, MegaGen Implant Co., Ltd., is located in the Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this submission is for a medical device (dental implant) and its physical properties (e.g., fatigue strength), not for an AI/diagnostic software where expert ground truth would be established. The "ground truth" here is the physical performance of the device under mechanical stress.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical image interpretation or diagnostic studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for the physical performance of a dental implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through physical testing and engineering standards. Specifically, comparative fatigue testing per ISO 14801 was used. This standard defines methods for dynamic fatigue testing of endosseous dental implants.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
{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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
October 8, 2019
MegaGen Implant Co., Ltd. JiYoung Son Assistant Reserch Engineer 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu REPUBLIC OF KOREA
Re: K191127
Trade/Device Name: Advanced Intermezzo Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 20, 2019 Received: July 10, 2019
Dear JiYoung Son:
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.
Srinivas Nandkumar for Acting Director DHT1B: Division of Dental 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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191127
Device Name
Advanced Intermezzo Implant St stem
Indications for Use (Describe)
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodonic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants.
The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition. Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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}------------------------------------------------
V. 510(k) SUMMARY (K191127)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: October 08, 2019
Applicant / Submitter 1.
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
JiYoung Son MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2988 Fax: + 82-53-289-3420 Email: rnd_ra5@imegagen.com
3. Device
- Trade Name: Advanced Intermezzo Implant System "
- . Common Name: Endosseous Dental Implant
- Classification Name: Endosseous Dental Implant י
- " Product Code: DZE, NHA
- Classification regulation: Class II, 21 CFR 872.3640 .
4. Predicate Device:
- . Primary Predicate: K051018 Intermezzo Implant System
- . Reference Devices: K112540 S-MiNi Implant K123870 XPEED AnyRidge Internal Implant System
{4}------------------------------------------------
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k)Number | K191127 | K051018 | K112540 | K123870 |
| DeviceName | Advanced IntermezzoFixture | IntermezzoTM ImplantFixture | S-MiNi Implant | XPEED AnyRidge InternalImplant System |
| Manufacturer | MegaGen Implant Co.,Ltd. | MegaGen Implant Co.,Ltd. | Neobiotech Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indicationsfor UseStatement | Advanced IntermezzoImplant Systems isthreaded one-pieceimplants designed fororthodontic one-stagesurgical procedures inupper and lower jaw toprovide a means ofprosthetic attachment torestore a patient's chewingfunction.Advanced IntermezzoImplant System consists ofsingle-stage, root-formdental implants.The system is designed toprovide immediateprovisional implant toprovide temporary supportfor prosthetic devicesduring the healing phase ofpermanent root formimplants. Depends on apatient's quality of bonecondition, AdvancedIntermezzo Fixtures are tobe removed within six toten weeks after the surgery.The system is intended forimmediate placement inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cement retained, screwretained, or overdenturerestorations. | IntermezzoTM ImplantSystems is threaded one-piece implants designed fororthodontic one-stagesurgical procedures inupper and lower jaw toprovide a means ofprosthetic attachment torestore a patient's chewingfunction.IntermezzoTM ImplantSystem consists of single-stage, root-form dentalimplants.The system is designed toprovide immediateprovisional implant toprovide temporary supportfor prosthetic devicesduring the healing phase ofpermanent root formimplants. Depends on apatient's quality of bonecondition, IntermezzoTMFixtures are to be removedwithin six to ten weeksafter the surgery. Thesystem isintended for immediateplacement in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cement retained, screwretained, or overdenturerestorations. | The S-MiNi Implant isindicated for use in thetreatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to serve astemporary supportprosthetic devices duringthe healing phase ofpermanent endosseousdental implant, such asartificial teeth, in order torestore chewing function inpartially edentulouspatients. | The Xpeed AnyRidgeInternal Implant System isintended to be surgicallyplaced in the maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplants (less than Ø 6.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading. |
| Appearance | Image: silver colored implant | Image: gold colored implant | Image: silver colored implant | Image: dark blue colored implant |
| Material | CP Ti Grade 4 | CP Ti Grade 3 | CP Ti Grade 4 | CP Ti Grade 4 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Diameter(Ø) | 2.2/ 2.6/ 3.0 mm | 1.8/ 2.2/ 2.5/ 3.1 mm | 2.0 / 2.5/ 3.0/ 3.5 mm | Internal type4.0, 4.4, 4.9, 5.4, 5.9mm(For normal ridge) |
| Length (mm) | 7.0/ 8.5/ 10.0/ 11.5/ 13.0 mm | 10.0/ 11.5/ 13.0/ 15.0 mm | 7.0/8.5/10.0/11.5/13.0/15.0 mm | 6.4, 6.9, 7.4, 7.9, 8.4mm(For low ridge)Internal type7.7, 9.2, 10.7, 12.2,14.20, 17.2mm(For normal ridge)7.9, 9.4, 10.9, 12.4,14.4mm(For low ridge) |
| Surfacetreatment | Sand-blasted, Large grit,Acid-etched (S.L.A) | RBM | RBM | Sand-blasted, Large grit,Acid-etched (S.L.A) |
| Implant-to-abutmentconnection | One-Piece Implant | One-Piece Implant | One-Piece Implant | Hex |
| Feature | Root-Form, Threaded | Root-Form, Threaded | Root-Form, Threaded | Tapered Form, Threaded |
| Sterilization | Sterile | Sterile | Sterile | Sterile |
| Principle ofoperation | This product is a root-typefixture which is inserted inthe alveolar bone. | This product is a root-typefixture which is inserted inthe alveolar bone. | This product is a root-typefixture which is inserted inthe alveolar bone. | This product is a taperedbody fixture which isinserted in the alveolarbone. It replaces thefunctions of the missingteeth as a dental implantfixture. |
| Shelf Life | 5 Years | 5 Years | - | 5 Years |
| Substantial Equivalence Discussion | ||||
| The subject device has the same material, indication for use, and principle of operation as the predicate device. | ||||
| The difference between the subject device has the same material, indication for use, and principle of operation as the predicate device. |
{5}------------------------------------------------
The unfect between the subject device and the difference in diameter and length is covered by reference 1 In comparison with fixture design, the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
{6}------------------------------------------------
| Comfort Cap | ||
|---|---|---|
| Subject Device | Predicate Device | |
| 510(k) Number | K191127 | K051018 |
| Device Name | Comfort Capfor Advanced Intermezzo System | Intermezzo Protective Capfor Intermezzo System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications forUse Statement | Advanced Intermezzo Implant Systems is threadedone-piece implants designed for orthodontic one-stagesurgical procedures in upper and lower jaw to provide ameans of prosthetic attachment to restore a patient'schewing function.Advanced Intermezzo Implant System consists ofsingle-stage, root-form dental implants.The system is designed to provide immediateprovisional implant to provide temporary support forprosthetic devices during the healing phase ofpermanent root form implants. Depends on a patient'squality of bone condition, Advanced IntermezzoFixtures are to be removed within six to ten weeks afterthe surgery. The system is intended for immediateplacement in partially or fully edentulous mandiblesand maxillae, in support of single or multiple-unitrestorations including; cement retained, screw retained,or overdenture restorations. | IntermezzoTM Implant Systems is threaded one-pieceimplants designed for orthodontic one-stage surgicalprocedures in upper and lower jaw to provide a meansof prosthetic attachment to restore a patient's chewingfunction.IntermezzoTM Implant System consists of single-stage,root-form dental implants.The system is designed to provide immediateprovisional implant to provide temporary support forprosthetic devices during the healing phase ofpermanent root form implants. Depends on a patient'squality of bone condition, IntermezzoTM Fixtures are tobe removed within six to ten weeks after the surgery.The system is intended for immediate placement inpartially or fully edentulous mandibles and maxillae, insupport of single or multiple-unit restorationsincluding; cement retained, screw retained, oroverdenture restorations. |
| Appearance | Image: [Appearance of subject device] | Image: [Appearance of predicate device] |
| Diameter | 3.6 mm | 3.2 mm |
| Length | 9.0 mm | 9.2 mm |
| Surface treatment | Injection molding | Injection molding |
| Sterility | Non-sterile; intended for terminal sterilization viamoist heat(autoclave) | Non-sterile; intended for terminal sterilization viamoist heat(autoclave) |
| Angulation | Straight | Straight |
| Material | POM | POM |
| Principle ofoperation | This product is a cap to prevent damage of tongue bythe post area of fixture in oral cavity. | This product is a cap to prevent damage of tongue bythe post area of fixture in oral cavity. |
| Substantial Equivalence Discussion | ||
| device. | The subject device has the same intended use, material, surface treatment, design, and principle of operation as the predicateThe size range of the subject device is slightly different from the predicate devices. |
5. Description:
The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method.
The system offers the following components. - Comfort Cap
{7}------------------------------------------------
Indication for use: 6.
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic onestage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function.
Advanced Intermezzo Implant System consists of single-stage, root-form dental implants.
The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
7. Basis for Substantial Equivalence
Advanced Intermezzo Implant System is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are material and have similar design. There are slight differences in design, however, it is very minor not affecting substantial equivalence. We have performed the fatigue test, and the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.
8. Non-Clinical Testing
- · Sterilization validating testing has been performed in accordance with ISO 11137 -1.2.3
- · 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 year shelf life.
- The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analysis.
- The fixture has the same material as the predicate device (K051018), the cap to protect abutment parts has the same material as the predicate device (K051018). The biocompatibility of the predicate final products was evaluated under the previous 510K submission.
- · The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 <85>.
- · Comparative fatigue testing per ISO 14801 was conducted on the subject device and primary predicate
9. Conclusion
Based on the similarities, we conclude that the Advanced Intermezzo Implant System is substantially equivalent to the predicate devices.
§ 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.