Who is the manufacturer of Chaorum Implant System?

Medimecca Co., Ltd. filed the 510(k) submission for Chaorum Implant System (K160536).

What is the FDA product code for Chaorum 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 Chaorum Implant System?

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

Who can help prepare an FDA 510(k) submission like Chaorum 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.

Chaorum Implant System

K160536 · Medimecca Co., Ltd. · DZE · Jan 5, 2017 · Dental

Device Facts

Record ID	K160536
Device Name	Chaorum Implant System
Applicant	Medimecca Co., Ltd.
Product Code	DZE · Dental
Decision Date	Jan 5, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Device Story

Chaorum Implant System consists of titanium fixtures, abutments, and screws for surgical placement in maxilla or mandible. Devices provide support for prosthetic teeth to restore chewing function and esthetics. System utilizes RBM or SLA surface treatments. Implants are placed via single or two-stage surgical procedures; intended for delayed loading. Healthcare providers (dentists/oral surgeons) use the system to anchor restorations. Clinical benefit includes restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. Evidence includes physical testing (dimension, sterility, packaging), surface characterization (SEM, EDX, roughness), mechanical testing (fatigue, torsional, compressive load, adaptation accuracy), and biocompatibility testing per ISO 10993 series (cytotoxicity, systemic toxicity, intracutaneous reactivity, pyrogen, LLNA, bone implantation).

Technological Characteristics

Materials: Titanium 6AL4V (ASTM F136) and Titanium Gr 4 (ASTM F67). Surface: RBM or SLA. Connection: Internal Hexagon. Sterilization: Gamma irradiation. Components: Fixtures, abutments (including TiN coated), and cover screws. Dimensions: 3.25-6.0mm diameter; 7.3-15.0mm length.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support.

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

UD Implant System (K131682)

Reference Devices

Hahn Tapered Implant System (K143353)
JDentalCare Implant System (K143142)
IDI Implant Systems (K081806)
NobelActive (K142260)
3I OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341)

Related Devices

K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
K062030 — US SYSTEM · Osstem Implant Co., Ltd. · Nov 2, 2006
K222707 — IH Implant System · Sewonmedix, Inc. · Jul 7, 2023
K171179 — BR Type Implant System · Biotem Co., Ltd. · Feb 9, 2018
K131748 — OSSEOFUSE DENTAL IMPLANT SYSTEM · Osseofuse, Inc. · Oct 31, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 5, 2017 Medimecca Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92606 Re: K160536 Trade/Device Name: Chaorum Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: December 6, 2016 Received: December 8, 2016 Dear Priscilla Chung: 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. 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 {1}------------------------------------------------ the quality systems (OS) 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, Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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) K160536 Device Name Chaorum Implant System Indications for Use (Describe) Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff "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." PRAStaff@fda.hhs.gov Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: 12/06/2016 # 1. Applicant / Submitter | | Submitter | |---------|----------------------------------------------------------------------------------------------------------------------------------------| | Name | Medimecca Co., Ltd. | | Address | Daeryung Techno town 3-cha 104, 105, 109, 110 Gasan- dong,115, GasanDigital 2-ro, Geumcheon-gu, Seoul, Republic of Korea 153-772 | | Phone | +82-2-856-8282 | | Fax | +82-2-856-0238 | | Contact | Park Young Wan, QMR | # 2. U.S Agent/Contact Person Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92606 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com # 3. Device - Trade Name: Chaorum Implant System - Common Name: Dental Implant System . - . Classification Name: Endosseous Dental Implant System - Product Code: DZE, NHA - . Classification regulation: 21CFR872.3640 # 4. Predicate Device: - Primary Predicate Device: . UD Implant System by MEDIMECCA Co., Ltd. (K131682) - . Reference Predicate Device: Hahn Tapered Implant System by PRISMATIK DENTALCRAFT, INC (K143353) JDentalCare Implant System by J DENTAL CARE S.r.l.. (K143142) {4}------------------------------------------------ IDI Implant Systems by IDI BIOMEDICAL LLC (K081806) NobelActive® by NOBEL BIOCARE USA, LLC (K142260) 31 OSSEOTITE CERTAIN DENTAL IMPLANTS by IMPLANT INNOVATIONS, INC. (K063341) ### 5. Description: Chaorum Implant System are devices made of titanium 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, and to restore the patients chewing function. Chaorum Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantially equivalent to the predicate devices. It offers three different implants in RBM treatment and SLA treatment. #### 5.1. Fixtures -RBM (Titanium 6AL4V, ASTM F136) | Shape | Size | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image: SFB Model Series | NP (Narrow Platform) Connection Type Fixture 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L) /14.0mm(L) / 15.0mm(L) 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) RP (Regular Platform) Connection Type Fixture 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | | Image: ASFS Model Series | NP (Narrow Platform) Connection Type Fixture 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / / 12.0mm(L) /14.0mm(L) 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) RP (Regular Platform) Connection Type Fixture 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.28mm Dia. x 8.0mm(L) / 10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | | Image: MSF Model | NP (Narrow Platform) Connection Type Fixture 3.25mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) 3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) / 15.0mm(L) RP (Regular Platform) Connection Type Fixture 4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) | 510(k) Submission. 510(k) summary , 2 / 10 page {5}------------------------------------------------ Series 5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) #### 5.2. Fixtures --SLA(Titanium Gr 4, ASTM F67) | Shape | Size | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image: ASF Model Series | NP (Narrow Platform) Connection Type Fixture 3.25mm Dia. x 8.0mm(L) / 8.5mm (L) / 10.0mm(L) / 12.0mm(L) / 14.0mm(L) / 15.0mm(L)/15.5mm(L) 3.89mm Dia. x 8.0mm(L)/10.0mm(L) / 12.0mm(L) / 14.0mm(L) RP (Regular Platform) Connection Type Fixture 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | | Image: ATF Model Series | NP (Narrow Platform) Connection Type Fixture 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) RP (Regular Platform) Connection Type Fixture 3.89mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 4.78mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 5.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) 6.28mm Dia. x 8.0mm(L) /10.0mm(L) / 12.0mm(L) / 14.0mm(L) | | Image: PSF Model Series | NP (Narrow Platform) Connection Type Fixture 3.75mm Dia. x 8.5mm (L) / 10.0mm(L) / 11.50mm(L) /13.0mm(L) / 15.0mm(L) RP (Regular Platform) Connection Type Fixture 4.30mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 4.50mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L)/15.0mm(L) 5.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) 6.00mm Dia. x 7.3mm(L) /8.5mm(L) / 10.0mm(L) / 11.5mm(L)/ 13.0mm(L) / 15.0mm(L) | {6}------------------------------------------------ #### 5.3. Abutments - · NP (Narrow Platform) Connection Type Two Piece Abutments | Abutments | Material | Dia(mm) | |--------------------------------------|--------------------------------------------------------------|-------------| | Dual Abutment | | 3.5/4.0/4.5 | | Combi Abutment | | 3.5/4.0/4.5 | | Angled Abutment (15°,17°, 25°) | MSAA-- CSAA-- Titanium Gr 4 ASTM F 67 / TiN Coating | 3.5/4.0/4.5 | | Billow Abutment | | 3.5/4.0/4.5 | | Temporary Abutment | | 3.5/4.0/4.5 | | Ball Abutment | | 3.5/4.0 | | Healing Abutment | Ti6AL4V ELI, ASTM F 136 | 3.5/4.0/4.5 | - · RP (Regular Platform) Connection Type Two Piece Abutments | Abutments | Material | Dia(mm) | |--------------------------------------|----------------------------|-------------------------------------| | Dual Abutment | | 4.5/5.0/5.5/6.0/6.5 | | Combi Abutment | | 4.5/5.0/5.5/6.0/6.5 | | Angled Abutment (15°,17°, 25°) | MSAA-- | 4.5/5.0/5.5/6.0 | | | CSAA-- | | | Billow Abutment | | 4.5/5.0/5.5/6.0/6.5 | | Temporary Abutment | | 4.5/5.0/5.5 | | Ball Abutment | | 3.5/4.0 | | Healing Abutment | Ti6AL4V ELI, ASTM F 136 | 4.0/4.5/5.0/5.5/6.0/ 6.5/7.5/8.5 | - 5.4. Cover Screws (Ti6AL4V ELI, ASTM F 136) 1.95mm Dia. x 5.8mm (L) / 6.5mm(L) #### 6. Indication for use: Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. {7}------------------------------------------------ ### 7. Basis for Substantial Equivalence The Chaorum Dental Implant System has the identified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with RBM or SLA roughened surfaces. The subject and predicate devices are both bone-level implants that shape design such as straight walled neck and tapered body design. The subject and predicate devices are similar in size, materials, surface treatment, and are sterlized via gamma irradiation for fixtures. | Item | Subject Device | Primary Predicate Device | Reference Predicate Devices | | | | | | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 510(K) Number | - | K131682 | K143353 | K143142 | K081806 | K142260 | K063341 | | | Device Name | Chaorum Implant System | UD Implant System | Hahn Tapered Implant System | JDentalCare Implant System | IDI Implant Systems | NobelActive® | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | | | Manufacturer | MEDIMECCA Co., Ltd. | MEDIMECCA Co., Ltd. | PRISMATIK DENTALCRAFT, INC | J DENTAL CARE S.r.l. | IDI BIOMEDICAL LLC | NOBEL BIOCARE USA, LLC | IMPLANT INNOVATIONS, INC | | | Indications for Use | Chaorum Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented | UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; | Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of | JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic | IDI Implant Systems (IDI Fixtures and IDI Abutments with screws) are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic | NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient | 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with | | 510(k) Submission. 510(k) summary , 5 / 10 page {8}------------------------------------------------ | retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Chaorum Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. | cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading. | primary stability and appropriate occlusal loading | devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screwretained or cemented restorations in mandible and maxilla. JDentalCare® | devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. | esthetics and chewing function. NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1- stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive® 3.0 implants are intended to replace a lateral incisor | multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, >IOmni in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated. | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | | implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. | | in the maxilla and/or a central or lateral incisor in the mandible. NobelActive® 3.0 implants are indicated for single unit restorations only. | | | | | Design/Principle of Operation | Image: dental implant | Image: dental implant | Image: dental implant | Image: dental implant - Endomaxim Internal Connection - Implant threads allow self drilling | Image: dental implant - Internal Hexagon connection - Self-taping cutting edge threads | Image: dental implant - Internal Hexagon connection - Self-taping cutting edge threads | | | | - Internal Hexagon connection - Self-taping cutting edge threads | - Internal Hexagon connection - Self-taping cutting edge threads | - Internal Hexagon connection - Self-taping cutting edge threads | | | | - Internal Hexa gon connection - Self-taping cutting edge threads | | Endosseous Implant Material | Titanium (ASTM F136, ASTM F67) | Titanium (ASTM F136, ASTM F67) | Titanium (ASTM F136, ASTM F67) | Titanium (ASTM F136, ASTM F67) Ti Gr. 5 for Ø 3,25mm | Titanium | CP Titanium | Titanium (ASTM F136, ASTM F67) | | Surface Treatment | RBM, SLA | RBM | RBM | SLA | RBM | TiUnite | SLA | | Implant Sterilization Method | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Ster ile | - | Radiation Sterile | - | | Implant Diameters | 3.25-6.0mm | 3.5-6.0mm | 3.0-7.0mm | 3.25-6.0mm | 3.5-6.0mm | 3.0-5.5mm | 3.25-6.0mm | | Implant Lengths | 7.3-15.0mm | 7.3-15.0mm | 8.0-16.0mm | 8.0-15.0mm | 8.8-16.0mm | 7.0-18.0mm | 7.0-20.0mm | | Angulations of Angled abutments | 15°, 17°, 25° | 15°, 25° | 15° ~ 30° | 0° ~ 30° | 15° | 0°~30° | 0-25° | | Abutments Diameters | 3.5-6.0mm | 4.0-6.0mm | 3.0-7.0mm | 3.2-6.0mm | - | 3.6-6.0mm | 3.4-7.5 | | Abutments Materials | - Ti-6Al-4V ELI - Titanium Gr | -Ti-6Al-4V ELI - Titanium Gr 4 | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | 510(k) Submission. 510(k) summary , 6 / 10 page {9}------------------------------------------------ 510(k) Submission. 510(k) summary , 7 / 10 page {10}------------------------------------------------ 510(k) Submission. 510(k) summary , 8 / 10 page {11}------------------------------------------------ | | 4 ASTM F 67 | ASTM F 67 | | | | | | |--|-------------|-----------|--|--|--|--|--| |--|-------------|-----------|--|--|--|--|--| {12}------------------------------------------------ # 8. Non-Clinical Testing The following non-clinical testing was conducted to validate its safety. - Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method) - RBM/SLA Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX) - TiN coating tests including surface roughness and abrasion testing - Mechanical properties test including adaptation accuracy test (Implant to abutment compatibility), 35° compressive loads test, torsional breaking force test, removal torque force test, and fatigue test - Sterilization validation and shelf life tests - The following biocompatibility tests have been performed in accordance with ISO10993 series. | No | Test Title | Test Standard | |----|-----------------------------------|------------------| | 1 | Cytotoxicity Test | ISO10993-5:2009 | | 2 | Acute Systemic Toxicity Test | ISO10993-11:2006 | | 3 | Intracutaneous Reactivity Test | ISO10993-10:2010 | | 4 | Pyrogen Test | ISO10993-11:2006 | | 5 | Local Lymph Node Assay, LLNA Test | ISO10993-10:2010 | | 6 | Bone Implantation Test | ISO10993-6:2007 | ### 9. Conclusion Based on the similarities and the test results of the validation activities, we conclude that the Chaorum Dental Implant System is substantially equivalent to the predicate device.