Who is the manufacturer of Advanced Intermezzo Implant System?

Megagen Implant Co., Ltd. filed the 510(k) submission for Advanced Intermezzo Implant System (K191127).

What is the FDA product code for Advanced Intermezzo Implant System?

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

What is the regulatory pathway for Advanced Intermezzo Implant System?

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

What are the predicate devices for Advanced Intermezzo Implant System?

Intermezzo Implant System (K051018).

Who can help prepare an FDA 510(k) submission like Advanced Intermezzo Implant System?

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.

Advanced Intermezzo Implant System

K191127 · Megagen Implant Co., Ltd. · DZE · Oct 8, 2019 · Dental

Device Facts

Record ID	K191127
Device Name	Advanced Intermezzo Implant System
Applicant	Megagen Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Oct 8, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Advanced Intermezzo Implant System consists of threaded, one-piece, root-form dental implants and comfort caps; used for immediate, temporary prosthetic support during healing of permanent implants. Implants are surgically placed in maxilla or mandible by dental professionals; provide attachment for cement-retained, screw-retained, or overdenture restorations. Comfort caps protect tongue from post area. System restores patient chewing function temporarily; fixtures removed after 6-10 weeks. Benefits include immediate provisionalization and support during osseointegration of permanent implants.

Clinical Evidence

No clinical data. Bench testing only: fatigue testing per ISO 14801, surface morphology (EDS), surface roughness analysis, GC/LC/IC analysis, sterilization validation (ISO 11137), shelf-life validation (ASTM F1980), and endotoxin testing (USP 39 <85>).

Technological Characteristics

Material: CP Ti Grade 4 (fixture), POM (cap). Surface: SLA (Sand-blasted, Large grit, Acid-etched). Principle: Root-form, threaded, one-piece dental implant. Sterilization: Gamma (fixture), moist heat/autoclave (cap). Dimensions: 2.2-3.0mm diameter, 7.0-13.0mm length.

Indications for Use

Indicated for partially or fully edentulous patients requiring temporary prosthetic support during the healing phase of permanent root-form dental implants in the maxilla or mandible. Implants are intended for removal within six to ten weeks post-surgery.

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

Intermezzo Implant System (K051018)

Reference Devices

S-MiNi Implant (K112540)
XPEED AnyRidge Internal Implant System (K123870)

Related Devices

K051018 — INTERMEZZO IMPLANT SYSTEMS · Megagen Co., Ltd. · Sep 2, 2005
K070568 — DIO PROTEM IMPLANT SYSTEM · Dio Department Dsi, Inc. · May 25, 2007
K051507 — MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM · Blue Sky Bio, LLC · Sep 2, 2005
K040946 — ANKYLOS DENTAL IMPLANT SYSTEM · Friadent GmbH · Jul 1, 2004
K122664 — ZUGA DENTAL IMPLANT SYSTEM · Zuga Medical, Inc. · Apr 30, 2013

Submission Summary (Full Text)

{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 | | Device Name | Advanced Intermezzo Fixture | IntermezzoTM Implant Fixture | S-MiNi Implant | XPEED AnyRidge Internal Implant System | | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Neobiotech Co., Ltd. | MegaGen Implant Co., Ltd. | | Indications for Use Statement | 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 provisional implant to 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. | IntermezzoTM 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. IntermezzoTM Implant System consists of single- stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, IntermezzoTM 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 S-MiNi Implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients. | 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 Ø 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. | | 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 type 4.0, 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 type 7.7, 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) | | Surface treatment | Sand-blasted, Large grit, Acid-etched (S.L.A) | RBM | RBM | Sand-blasted, Large grit, Acid-etched (S.L.A) | | Implant-to- abutment connection | 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 of operation | This product is a root-type fixture which is inserted in the alveolar bone. | This product is a root-type fixture which is inserted in the alveolar bone. | This product is a root-type fixture which is inserted in the alveolar bone. | This product is a tapered body fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | | 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…