AnyOne External Implant System

K203554 · Megagen Implant Co., Ltd. · DZE · Aug 28, 2021 · Dental

Device Facts

Record IDK203554
Device NameAnyOne External Implant System
ApplicantMegagen Implant Co., Ltd.
Product CodeDZE · Dental
Decision DateAug 28, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended Use

The AnyOne External 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 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.

Device Story

AnyOne External Implant System comprises endosseous dental fixtures and various abutments; surgically placed in maxillary or mandibular molar regions to support dental restorations (crowns, bridges, overdentures). Fixtures are CP Ti Grade 4 with SLA surface treatment; abutments are Ti-6Al-4V ELI. System restores chewing function and aesthetics. Operated by dental clinicians in clinical settings. Fixtures provide foundation; abutments connect to superstructures via screws. Components include cover screws, healing abutments, temporary abutments, EZ post abutments, angled abutments, milling abutments, gold abutments, multi-unit abutments, and overdenture attachments (Meg-Rhein). Output is a stable prosthetic foundation. Benefits include restoration of masticatory function and improved appearance.

Clinical Evidence

No clinical data. Bench testing only, including static compression-strength and fatigue testing per ISO 14801 and Class II Special Controls Guidance for Root-form Endosseous Dental Implants.

Technological Characteristics

Materials: CP Ti Grade 4 (ASTM F67-13) for fixtures; Ti-6Al-4V ELI (ASTM F136-13) for abutments/screws. Surface: SLA (sand-blasted, large-grit, acid-etched) for fixtures; anodizing/machined for abutments. Connection: External Hex. Sterilization: Gamma radiation. Shelf life: 5 years.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular molar areas. Smaller implants (<6.0mm) indicated for immediate loading with good primary stability; larger implants indicated for delayed loading.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. MegaGen Implant Co., Ltd. % You Jung Kim Chief Researcher DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA Re: K203554 Trade/Device Name: AnyOne External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 30, 2021 Received: July 30, 2021 Dear You Jung Kim: 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. Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203554 Device Name AnyOne External Implant System The AnyOne External 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 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. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The- </span> </span> | e-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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## K203554 # 510(k) Summary Date: August 28, 2021 # 1. Applicant / Submitter 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 You Jung Kim DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea Fax: +82-53-247-2254 Tel: +82-53-247-2258 Email: ra3@dgri.co.kr ## 3. Device | ▪ Trade Name: | AnyOne External Implant System | |--------------------------------|--------------------------------| | ▪ Common Name: | Endosseous Dental Implant | | ▪ Classification Name: | Endosseous dental implant | | ▪ Classification Product Code: | DZE | | ▪ Secondary Product Code: | NHA | | ▪ Classification regulation: | Class II, 21 CFR 872.3640 | #### Predicate Device 4. #### . Primary Predicate Device: K122231 - Xpeed AnyRidge Internal Implant System #### . Reference Devices: - K052369 ExFeel Dental Implant System - K123988 AnyOne Internal Implant System - K192347 ST Internal Implant System - K053353 Rescue Dental Implant System - K182448- AnyRidge Octa 1 Implant System - K150537 MiNi Internal Implant System - K192436 Healing Abutments and Cover Screws - K110955 AnyRidge Internal Implant System - K081302 Rescue External Implant System - K160670 ET US SS Prosthetic System - K171142 Healing Cap Multi-Unit Titanium - K182091 Osstem Abutment System K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment {4}------------------------------------------------ # 5. Description - . AnyOne External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance. - . AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function. | | | | Content | |-----------------------------------------------|-------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Fixture | AnyOne<br>External<br>Fixture | Description | AnyOne External Fixture is a substructure of a dental<br>implant system made of titanium and have the interface<br>connection for External Hex. It is used in conjunction with<br>other prosthetic and restore lost chewing ability, improve<br>appearance. | | | | Material | CP Ti Grade 4 (ASTM F67-13) | | | | Dimension<br>(Diameter & Length) | $Ø$ 3.9 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 4.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 4.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 5.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 5.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 6.3 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm<br>$Ø$ 6.8 x 7.0, 8.0, 9.5, 11.0, 12.5, 14.5 mm | | 2. Cover<br>Screw<br>&<br>Healing<br>Abutment | Cover<br>Screw | Description | The Cover Screw is used in conjunction with fixture for<br>protecting the inner structure of a fixture, and exposed<br>fixture platform after fixture placement. | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | $Ø$ 3.5 x 5.3, 6.2 mm<br>$Ø$ 4.1 x 5.3, 6.2 mm<br>$Ø$ 5.0 x 5.3, 6.2 mm | | | | Gingival (Cuff) Heights | 1.3 mm | | | | Angulation | Straight | - . The proposed AnyOne External Implant System is consisted of the following components. For reference, all the subject device in this submission are to be added Megagen's existing implant and | Screw<br>&<br>Healing<br>Abutment | Screw | | protecting the inner structure of a fixture, and exposed<br>fixture platform after fixture placement. | |-----------------------------------|---------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Healing<br>Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | Ø 3.5 x 5.3, 6.2 mm<br>Ø 4.1 x 5.3, 6.2 mm<br>Ø 5.0 x 5.3, 6.2 mm | | | | Gingival (Cuff) Heights | 1.3 mm | | | | Angulation | Straight | | | | Description | The Healing Abutment is used in conjunction with fixture<br>and helps to form suitable emergence profile during period<br>of gingival healing. | | | Healing<br>Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | Ø 4.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm<br>Ø 5.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm<br>Ø 6.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm<br>Ø 7.0 x 6.8, 7.7, 7.8, 8.7, 8.8, 9.7, 9.8, 10.7, 11.8, 12.7 mm | | | | Gingival (Cuff) Heights | 2.0, 3.0, 4.0, 5.0, 7.0 mm | | | | Angulation | Straight | | | | Description | The Esthetic Healing Abutment is used in conjunction with<br>fixture and helps to form suitable emergence profile during<br>period of gingival healing. It is helpful to maintain more<br>thickness of soft tissue and easy to make soft tissue closure<br>against narrow top. | | | Esthetic<br>Healing<br>Abutment | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | Dimension<br>(Diameter & Length) | Ø 3.5 x 6.2, 7.2, 8.2 mm<br>Ø 4.1 x 6.2, 7.2, 8.2 mm<br>Ø 5.0 x 6.2, 7.2, 8.2 mm | | | | Gingival (Cuff) Heights | 2.5, 3.5, 4.5 mm | | | | Angulation | Straight | {5}------------------------------------------------ | 3. Fixture<br>Level<br>Prosthesis | Temporary<br>Abutment | Description | The Temporary Abutment is used in conjunction with fixture<br>to provide support for provisional restoration. It is<br>connected to the Fixture using Abutment Screw. It has a<br>maximum intra-oral use of 180-days. | | | | | |-----------------------------------|-----------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------|--| | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | Dimension<br>(Diameter & Length) | Ø 3.9 x 12.0 mm<br>Ø 4.5 x 12.0 mm<br>Ø 5.5 x 12.0 mm | | | | | | | | Post Heights | 10.0 mm | | | | | | | | Gingival (Cuff) Heights | 1.3 mm | | | | | | | | Angulation | Straight | | | | | | | EZ Post<br>Abutment | Description | The EZ Post Abutment is used in conjunction with fixture to<br>provide support for cement and screw retained type final<br>prosthesis. It is connected to the Fixture using Abutment<br>Screw. | | | | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | Dimension<br>(Diameter & Length) | Ø 4.0 x 10.0, 12.0 mm<br>Ø 5.0 x 9.0, 10.0, 11.0, 12.0 mm<br>Ø 6.0 x 9.0, 10.0, 11.0, 12.0 mm | | | | | | | | Post Heights | 8.0 mm | | | | | | | | Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0 mm | | | | | | | | Angulation | Straight | | | | | | | Angled<br>Abutment | Description | The Angled Abutment is used in conjunction with fixture and<br>used for correcting the prosthetic angulation of implant. It<br>is connected to the Fixture using Abutment Screw. | | | | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | Dimension<br>(Diameter & Length) | Ø 4.0 x 9.0, 11.0 mm<br>Ø 5.0 x 9.0, 11.0 mm<br>Ø 6.0 x 9.0, 11.0 mm | | | | | | | | Post Heights | 7.0 mm | | | | | | | | Gingival (Cuff) Heights | 2.0, 4.0 mm | | | | | | | | Angulation | 15°, 25° | | | | | | | Milling<br>Abutment | Description | The Milling Abutment is used in conjunction with fixture and<br>used for establishing an adequate safety margin from<br>occlusal line by hand milling of the post part. It is connected<br>to the Fixture using Abutment Screw.<br>(Note. Only be for Hand Milling with no CAD/CAM) | | | | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | Dimension<br>(Diameter & Length) | Ø 4.0 x 11.0, 13.0 mm<br>Ø 5.0 x 10.0, 11.0, 12.0, 13.0 mm<br>Ø 6.0 x 10.0, 11.0, 12.0, 13.0 mm<br>Ø 7.0 x 10.0, 11.0, 12.0, 13.0 mm | | | | | | | | Post Heights | 9.0 mm | | | | | | | | Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0 mm | | | | | | | | Angulation | Straight | | | | | | | Gold<br>Abutment | Description | The Gold Abutment is used in conjunction with fixture and<br>used for fabrication of abutment for either screw or cement<br>retained restorations by casting with precious metal alloy. It<br>is connected to the Fixture using Abutment Screw. | | | | | | | | Material | Body: Gold Alloy / Sleeve: POM | | | | | | | | Dimension<br>(Diameter & Length) | Ø 4.0 x 11.0 mm<br>Ø 4.5 x 11.2 mm<br>Ø 5.5 x 11.2 mm | | | | | | | | Post Height | 10.0 mm | | | | | | | | Gingival (Cuff) Heights | 1.0, 1.2 mm | | | | | | | | Angulation | Straight | | | | | | | Abutment<br>Screw | Description | The Abutment Screw is used for connecting Fixture to<br>Temporary Abutment, EZ Post Abutment, Angled<br>Abutment, Milling Abutment or Gold Abutment. | | | | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | | | Dimension<br>(Diameter & Length) | Dimension<br>(Diameter & Length) | Ø 2.5 x 7.5 mm | | | 4.Abutment<br>Level<br>Prosthesis | Regular<br>Abutment | Description | The Regular Abutment is used in conjunction with fixture<br>and used for fabrication of either screw or cement retained<br>prosthetics. It is connected to the Fixture using Regular<br>Abutment Screw. | | | | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | | | | Dimension<br>(Diameter & Length) | Ø 4.5 x 3.0, 4.0, 5.5, 7.0, 8.5 mm<br>Ø 4.8 x 3.0, 3.8, 4.8, 5.8 mm | | | | | | | | Post Heights | 1.8 mm | | | | | {6}------------------------------------------------ | | Gingival (Cuff) Heights | 1.2, 2.0, 3.0, 4.0 mm | | | |----------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | | Angulation | Straight | | | | Regular<br>Abutment<br>Screw | Description | The Regular Abutment Screw is used for connecting Fixture<br>to Regular Abutment. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 2.95 x 8.85, 9.85, 10.85, 11.85 mm<br>$Ø$ 3.5 x 7.9, 9.05, 10.55, 12.05, 13.55 mm | | | | Multi-unit<br>Abutment | Description | The Multi-unit Abutment is used in conjunction with fixture<br>to fabricate screw-retained prosthesis. It is two-piece type<br>and connected the fixture with Multi-unit Abutment Screw. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.8 x 2.0, 3.0, 4.0, 5.0, 6.0 mm | | | | | Post Heights | 1.0 mm | | | | | Gingival (Cuff) Heights | 1.0, 2.0, 3.0, 4.0, 5.0 mm | | | | | Angulation | Straight | | | | Multi-unit<br>Angled<br>Abutment | Description | The Multi-unit Angled Abutment is used in conjunction with<br>fixture for fabricating screw-retained prosthesis and<br>correcting the prosthetic angulation of implant. It is two-<br>piece type and connected the fixture with Multi-unit<br>Abutment Screw. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.8 x 3.65, 4.65, 5.13, 5.65, 6.13 mm | | | | | Post Heights | 2.2 mm | | | | | Gingival (Cuff) Heights | 2.0, 3.0, 4.0, 5.0 mm | | | | | Angulation | 17°, 30° | | | | Multi-unit<br>Abutment<br>Screw | Description | The Multi-unit Abutment Screw is used for connecting<br>Multi-unit Abutment or Multi-unit Angled Abutment to the<br>fixture. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 2.4 x 6.8 mm<br>$Ø$ 2.9 x 6.7, 7.7, 8.7, 9.7, 10.7 mm | | | | Healing Cap | Description | The Healing Cap is used for protecting Regular Abutment or<br>Multi-unit (Angled) Abutment and minimizing irritation to<br>tongue and oral mucosa during period of gingival healing. It<br>is connected to the Abutment using its threaded part or<br>Cylinder Screw. It has a maximum intra-oral use of 180-days. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.9 x 4.2 mm<br>$Ø$ 5.0 x 6.1 mm<br>$Ø$ 6.8 x 4.2 mm | | | | Temporary<br>Abutment | Description | The Temporary Abutment is used in conjunction with<br>Regular Abutment to provide support for provisional<br>restoration. It is connected to the Abutment using<br>Abutment Screw. It has a maximum intra-oral use of 180-<br>days. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.8 x 12.35 mm | | | | | Post Heights | 7.5 mm | | | | | Gingival (Cuff) Heights | 2.8 mm | | | | Temporary<br>Cylinder | Angulation | Straight | | | | | Description | The Temporary Cylinder is used in conjunction with Multi-<br>unit (Angled) Abutment to provide support for provisional<br>restoration. It is connected to the Abutment using Cylinder<br>Screw. It has a maximum intra-oral use of 180-days. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13) | | | | | Dimension<br>(Diameter & Length) | $Ø$ 4.8 x 12.0 mm | | | | | Post Heights | 8.5 mm | | | | | Gingival (Cuff) Heights | 3.0 mm | | | | | Angulation | Straight | | | | EZ Post<br>Cylinder | Description | The EZ Post Cylinder is used in conjunction with Regular<br>Abutment to provide support for cement and screw type<br>final prosthesis. It is connected to the Abutment using<br>Abutment Screw. | | | | | Dimension<br>(Diameter & Length) | Material | $\unicode{x2300}$ 5.0 x 8.5 mm | Ti-6A1-4V ELI (ASTM F136-13) | | | | Post Heights | 7.7 mm | | | | | Gingival (Cuff) Heights | 0.8 mm | | | | | Angulation | Straight | | | | Gold<br>Cylinder | Description | The Gold Cylinder is used in conjunction with Regular<br>Abutment to provide support for screw type final prosthesis<br>by casting with precious metal alloy. It is connected to the<br>Abutment using Abutment Screw. | | | | | Material | Body: Gold Alloy / Sleeve: POM | | | | | Dimension<br>(Diameter & Length) | Ø 4.8 x 13.0 mm | | | | | Post Heights | 10.0 mm | | | | | Gingival (Cuff) Heights | 3.0 mm | | | | | Angulation | Straight | | | | CCM<br>Cylinder | Description | The CCM Cylinder is used in conjunction with Regular<br>Abutment or with Multi-unit (Angled) Abutment to provide<br>support for screw type final prosthesis by casting with non-<br>precious metal alloy. It is connected to the Abutment using<br>Abutment Screw or Cylinder Screw. | | | | | Material | Body: Co-Cr-Mo Alloy / Sleeve: POM | | | | | Dimension<br>(Diameter & Length) | Ø 4.8 x 13.0, 15.0 mm | | | | | Post Heights | 10.0, 13.0 mm | | | | | Gingival (Cuff) Heights | 2.0, 3.0 mm | | | | | Angulation | Straight | | | | Description<br>Abutment<br>Screw | | The Abutment Screw is used for connecting Regular<br>Abutment to Temporary Abutment, EZ Post Cylinder, Gold<br>Cylinder or CCM Cylinder. | | | | | Material | Ti-6A1-4V ELI (ASTM F136-13)…
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