Who is the manufacturer of TruAbutment DS; TruBase?

Truabutment, Inc. filed the 510(k) submission for TruAbutment DS; TruBase (K241485).

What is the FDA product code for TruAbutment DS; TruBase?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TruAbutment DS; TruBase?

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

What are the predicate devices for TruAbutment DS; TruBase?

TruAbutment DS (K203649); TruBase (K203649).

Who can help prepare an FDA 510(k) submission like TruAbutment DS; TruBase?

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.

TruAbutment DS; TruBase

K241485 · Truabutment, Inc. · NHA · Oct 9, 2024 · Dental

Device Facts

Record ID	K241485
Device Name	TruAbutment DS; TruBase
Applicant	Truabutment, Inc.
Product Code	NHA · Dental
Decision Date	Oct 9, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations.

Device Story

TruAbutment DS and TruBase are patient-specific, CAD/CAM-manufactured dental abutments; they connect directly to endosseous dental implants to support prosthetic restorations (crowns/copings). The device is used in dental clinics; the clinician orders the patient-specific design based on intra-oral indications. Designs are sent to a TruAbutment-validated milling center for fabrication. TruAbutment DS is for screw-retained restorations; TruBase supports cemented zirconia superstructures. The devices are provided non-sterile and require end-user steam sterilization. The output is a custom-fit abutment that restores chewing function and aesthetics for the patient. The healthcare provider uses the device to bridge the gap between the implant and the final dental prosthesis.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including static compression and compression fatigue testing (ISO 14801), dimensional analysis, and reverse engineering of implant-to-abutment interfaces. Biocompatibility and sterilization validation were leveraged from reference devices.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Construction: Machined CAD/CAM patient-specific abutments. Connection: Internal hex, spline, tube-in-tube, or conical interfaces depending on OEM system. Sterilization: Non-sterile, requires end-user steam sterilization. Connectivity: CAD/CAM digital workflow. Design limits: Angulation 0-25 degrees (DS) or 0-15 degrees (Base); cuff height 0.5-6.0mm; wall thickness min 0.4mm.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. TruAbutment DS is for screw-retained restorations. TruBase is for screw-retained single tooth or cement-retained single tooth and bridge restorations. Compatible with specific OEM implant systems (Astra, Biomet 3i, DIO, Neoss, Osstem, Camlog, Conelog, Implant Direct, BioHorizons, MegaGen).

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

TruAbutment DS (K203649)
TruBase (K203649)

Reference Devices

Astra OsseoSpeed EV (K130999, K120414)
Biomet 3i Full OSSEOTITE Tapered Certain (K130949)
DIO UF (II) Internal Submerged (K161987, K170608, K173975)
Neoss ProActive (K083561)
Camlog Screw-Line (K083496)
Conelog Screw-Line (K113779)
Osstem TS Fixture System (K161604)
BioHorizons Laser-Lok 3.0 Implant System (K093321)
Biohorizons Tapered Internal Implant System (K143022, K071638)
Xpeed AnyRidge Internal Implant System (K140091)
Implant Direct Legacy2 (K192221)
InCoris Zi (K123664)
RelyX Unicem 2Automix (K100756)

Related Devices

K202579 — TruAbutment DS, TruBase · Truabutment, Inc. · Jul 8, 2021
K213961 — TruAbutment DS, TruBase · Truabutment, Inc. · Jul 14, 2022
K203649 — TruAbutment DS, TruBase · Truabutment, Inc. · Sep 15, 2021
K201197 — TruAbutment DS, TruBase S · Truabutment, Inc. · Mar 26, 2021
K222269 — DESS Dental Smart Solutions · Terrats Medical SL · Oct 26, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue. October 9, 2024 TruAbutment Inc. Ki Yoon Nam RA Senior Manager 17666 Fitch Irvine, California 92614 Re: K241485 Trade/Device Name: TruAbutment DS; TruBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 12, 2024 Received: September 12, 2024 Dear Ki Yoon Nam: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 3 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 -S 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 Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241485 Device Name TruAbutment DS; TruBase Indications for Use (Describe) {4}------------------------------------------------ TruAbutment DS TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: · Astra OsseoSpeed EV (K130999, K120414) - : 3.0, 3.6, 4.2, 4.8, 5.4 mm. - · Biomet 3i Full OSSEOTITE Tapered Certain (K130949) - : 3.25, 4.0, 5.0, 6.0 mm. - · DIO UF (II) Internal Submerged (K161987, K170608, K173975) : 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm. - · Neoss ProActive® (K083561) - : 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. - · Osstem TS (K161604) - : 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) mm. - · Camlog Screw-Line (K083496) - : 3.3, 3.8, 4.3, 5.0, 6.0 mm. - · Conelog Screw-Line (K113779) - : 3.3, 3.8, 4.3, 5.0 mm. - · Implant Direct Legacy2 (K192221) - : 3.2 mm. - · BioHorizons Internal Implant System (K093321, K143022, K071638) - : 3.0, 3.4, 3.8, 4.6, 5.8 mm. - · MegaGen AnyRidge Internal Implant (K140091) - : 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm. All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture. # TruBase TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: - · Astra OsseoSpeed EV (K130999): 3.0 mm. - · Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25, 4.0, 5.0, 6.0 mm. - · DIO UF(II) Internal Submerged (K161987, K170608, K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm. - · Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. - · Camlog Screw-Line (K083496); 3.3. 3.8. 4.3. 5.0. 6.0 mm. - · Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm. - · Implant Direct Legacy2 (K192221): 3.2 mm. All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture. 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. {5}------------------------------------------------ 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." {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is in blue and features the word "Abutment" in a bold, sans-serif font, stacked on top of the letters "ru", which are also in a bold, sans-serif font. To the left of the word "ru" is a graphic that resembles the threads of a screw or bolt, which may be a visual representation of the word "abutment". # 510(k) Summary K241485 | Submitter | Official Correspondent | |---------------------------------------|-----------------------------------| | TruAbutment Inc. | TruAbutment Inc. | | Rawa Abukhalaf | Ki Yoon Nam | | 17666 Fitch, | 17666 Fitch, | | Irvine, CA 92614 USA | Irvine, CA 92614 USA | | Email: rawa.abukhalaf@truabutment.com | Email: kiyoon.nam@truabutment.com | | Phone: 1-714-956-1488 | Phone: 1-714-956-1488 | #### Device Information - . Trade Name: TruAbutment DS, TruBase - Common Name: Abutment, Implant, Dental, Endosseous - Classification Name: Endosseous dental implant abutment - Product Code: NHA - Panel: Dental - Regulation Number: 21 CFR 872.3630 - Device Class: Class II - Date prepared: 10/09/2024. ● #### Primary Predicate / Reference Devices: The subject device is substantially equivalent to the following predicate device: #### Primary Predicate: - . TruAbutment DS (K203649) by TruAbutment Inc. #### Reference Devices for OEM Compatibilities: - Astra OsseoSpeed EV (K130999, K120414) by Astra Tech, Inc. ● - Biomet 3i Full OSSEOTITE Tapered Certain (K130949) by Zimmer Biomet. ● - DIO UF (II) Internal Submerged (K161987, K170608, K173975) by DIO Implant Co., Ltd. ● - Neoss ProActive® (K083561) by Neoss Limited. ● - Camlog Screw-Line (K083496) by CAMLOG Biotechnologies GmbH. . - Conelog Screw-Line (K113779) by CAMLOG Biotechnologies GmbH. - Osstem TS Fixture System (K161604) by Osstem Implant Co., Ltd. ● - BioHorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc. . {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are in a smaller, cursive font. To the left of the text, there is a stylized image of a screw, also in blue, which appears to be part of the "A" in "Abutment". - Biohorizons Tapered Internal Implant System (K143022) by Biohorizons Implant Systems, Inc. . - Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc. ● - . Xpeed AnyRidge Internal Implant System (K140091) by MegaGen Implant Co., Ltd. - Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, . Legacy4 fixture-mounts (K192221) by Implant Direct LLC. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a larger, bolder sans-serif font. To the left of the letters "ru" is a graphic of a screw. The entire logo is in a light blue color. #### General Description TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: - (1) For fixing the abutment into the endosseous implant. - (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices. Mechanical resistance of the implant-abutment connection is essential to ensure the correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established. The following table shows the subject device abutment platform sizes for each of the OEM implant lines and sizes. | TruAbutment Platform Diameter / Compatible Implant System | TruAbutment DS Engaging | TruAbutment DS Non-Engaging | TruBase Engaging | TruBase Non-Engaging | |-----------------------------------------------------------------|----------------------------|-----------------------------------|---------------------|-------------------------| | Astra OsseoSpeed EV | | | | | | 3.0 | X | 0 | 0 | 0 | | 3.6 | X | 0 | X | X | | 4.2 | X | 0 | X | X | | 4.8 | X | 0 | X | X | | 5.4 | X | 0 | X | X | | Biomet 3i Full OSSEOTITE Tapered Certain | | | | | | 3.4 | X | 0 | 0 | 0 | | 4.1 | X | 0 | 0 | 0 | | 5.0 | X | 0 | 0 | 0 | | 6.0 | X | 0 | 0 | 0 | | DIO UF (II) Internal | | | | | | Narrow | X | 0 | 0 | 0 | | Regular | X | 0 | 0 | 0 | | Neoss ProActive® | | | | | | NP | X | 0 | 0 | 0 | | SP | X | 0 | 0 | 0 | | Camlog Screw-Line | | | | | | 3.3 | 0 | 0 | 0 | 0 | | 3.8 | 0 | 0 | 0 | 0 | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a stylized font above the letters "ru". To the left of the letters "ru" is a graphic that resembles the side view of a screw or bolt, also in blue. The overall design is simple and modern, with a focus on the company's name and a visual element related to engineering or construction. | 4.3 | 0 | 0 | 0 | 0 | |------------------------|---|---|---|---| | 5.0 | 0 | 0 | 0 | 0 | | 6.0 | 0 | 0 | 0 | 0 | | Conelog Screw-Line | | | | | | 3.3 | 0 | 0 | 0 | 0 | | 3.8 | 0 | 0 | 0 | 0 | | 4.3 | 0 | 0 | 0 | 0 | | 5.0 | 0 | 0 | 0 | 0 | | Implant Direct Legacy2 | | | | | | 3.2 | 0 | 0 | 0 | 0 | | Osstem TS | | | | | | Mini | X | 0 | X | X | | Regular | X | 0 | X | X | | BioHorizons Internal | | | | | | 3.0 | X | 0 | X | X | | 3.5 | X | 0 | X | X | | 4.5 | X | 0 | X | X | | 5.7 | X | 0 | X | X | | MegaGen Xpeed | | | | | | AnyRidge Internal | | | | | | 3.5 | X | 0 | X | X | X: Not included in this submission O: Included in this submission #### TruAbutment DS TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serewretained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center. Design Limitation for TruAbutment DS | Design Parameter | Design Limit | |----------------------------------------------------------------------------------------------------------|--------------| | Minimum and Maximum abutment angle (°) | 0 ~ 25 | | Minimum and Maximum cuff height (mm) | 0.5 ~ 6.0 | | Minimum and Maximum diameter at abutment/implant interface (Ø, mm) | 3.3 ~ 8.0 | | Minimum thickness (mm) | 0.4 | | Minimum and Maximum length of abutment post (length above the abutment collar / gingival height) (mm) | 4.0 ~ 7.0 | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are in a smaller, cursive font. The "A" in "Abutment" is stylized to resemble a screw or bolt, possibly indicating the company's focus or industry. #### TruBase TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. Raw material blanks - InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. #### Cement - . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756. Design Limitation for Zirconia superstructure: | Design Parameter | Design Limit | |----------------------------------------------------------------------------------------------------------|--------------| | Minimum and Maximum angulation (°) | 0~15 | | Minimum and Maximum cuff height (mm) | 0.5 ~ 5.0 | | Minimum and Maximum diameter at abutment/implant interface (Ø, mm) | 5.0 ~ 8.0 | | Minimum thickness (mm) | 0.4 | | Minimum and Maximum length of abutment post (length above the abutment collar / gingival height) (mm) | 4.0 ~ 6.0 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font stacked above the letters "ru", which are stylized to appear as if they are connected. To the left of the text, there is a graphic of a screw, also in blue, which adds a visual element related to construction or engineering. #### Indication for Use #### TruAbutment DS TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: - · Astra OsseoSpeed EV (K130999, K120414) : 3.0, 3.6, 4.2, 4.8, 5.4 mm. - · Biomet 3i Full OSSEOTITE Tapered Certain (K130949) : 3.25, 4.0, 5.0, 6.0 mm. - · DIO UF (II) Internal Submerged (K161987, K170608, K173975) : 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm. - · Neoss ProActive® (K083561) : 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. - · Osstem TS (K161604) : 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) mm. - · Camlog Screw-Line (K083496) : 3.3, 3.8, 4.3, 5.0, 6.0 mm. - · Conelog Screw-Line (K113779) : 3.3, 3.8, 4.3, 5.0 mm. - · Implant Direct Legacy2 (K192221) : 3.2 mm. - · BioHorizons Internal Implant System (K093321, K143022, K071638) : 3.0. 3.4. 3.8. 4.6. 5.8 mm. - · MegaGen AnyRidge Internal Implant (K140091) : 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm. All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture. #### TruBase TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: - . Astra OsseoSpeed EV (K130999): 3.0 mm. - Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25.4.0, 5.0, 6.0 mm. - DIO UF(II) Internal Submerged (K161987, K170608, K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, . 6.5, 7.0 (Narrow, Regular) mm. - . Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. - Camlog Screw-Line (K083496): 3.3, 3.8, 4.3, 5.0, 6.0 mm. - Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm. - Implant Direct Legacy2 (K192221): 3.2 mm. ● {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is blue and white. The word "Abutment" is written in white letters on a blue background. The letters "ru" are written in blue letters on a white background. The logo has a jagged edge on the left side. All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture. | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | |----------------------------------------------------------------------------------------|-------------------------------------|---------------------------|---------------|-----------------------------------------|-------------------------------------------------| | Astra OsseoSpeed EV (K130999) (K120414) | 3.0 | 8 | 26301 | 3.0 | Internal Spline connection "Index System" | | | | 9 | 26302 | | | | | | 11 | 26303 | | | | | | 13 | 26304 | | | | | | 15 | 26305 | | | | | 3.6 | 6 | 26310 | | | | | | 8 | 26311 | | | | | | 9 | 26312 | 3.6 | | | | | 11 | 26313 | | | | | | 13 | 26314 | | | | | | 15 | 26315 | | | | | | 17 | 26316 | | | | 4.2 | 6 | 26320 | | | | | | | 8 | 26321 | 4.2 | | | | | 9 | 26322 | | | | | | 11 | 26323 | | | | | | 13 | 26324 | | | | | | 15 | 26325 | | | | | | 17 | 26326 | | | | 4.8 | 6 | 26340 | 4.8 | | | | | | 8 | | 26341 | | | | | 9 | | 26342 | | | | | 11 | | 26343 | | | | | 13 | | 26344 | | | | | 15 | | 26345 | | | | | 17 | 26346 | | | | 5.4 | 6 | 26360 | 5.4 | | | | | | 8 | | 26361 | | | | | 9 | | 26362 | | | | | 11 | | 26363 | | | | | 13 | | 26364 | | | | | 15 | 26365 | | | | | 3.25 | 8.5 | IENT3285 | 3.4 | | | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | | Biomet 3i Full OSSEOTITE Tapered Certain (K130949) | 4.0 | 10 | IFNT3210 | 4.1 | Image: Internal Hex Connection | | | | 11.5 | IFNT3211 | | | | | | 13 | IFNT3213 | | | | | | 15 | IFNT3215 | | | | | | 8.5 | IFNT485 | | | | | | 10 | IFNT410 | | | | | | 11.5 | IFNT411 | | | | | | 13 | IFNT413 | | | | | | 15 | IFNT415 | | | | | 5.0 | 8.5 | IFNT585 | 5.0 | Image: Internal Hex Connection | | | | 10 | IFNT510 | | | | | | 11.5 | IFNT511 | | | | | | 13 | IFNT513 | | | | | | 15 | IFNT515 | | | | | 6.0 | 8.5 | IFNT685 | | | | | | 10 | IFNT610 | | | | | | 11.5 | IFNT611 | | | | | | | | 6.0 | | | | | 13 | IFNT613 | | | | | | 15 | IFNT615 | | | | DIO UF (II) Internal Submerged Implant (K161987) (K170608) (K173975) | 3.3 | 8.5 | UF(II)N 3308S | Narrow (K161987) | Image: Internal Hex Connection | | | | 10 | UF(II)N 3310S | | | | | | 11.5 | UF(II)N 3311S | | | | | | 13 | UF(II)N 3313S | | | | | | 15 | UF(II)N 3315S | | | | | 3.8 | 8.5 | UF(II) 3808S | | | | | | 10 | UF(II) 3810S | | | | | | 11.5 | UF(II) 3811S | | | | | | 13 | UF(II) 3813S | | | | | | 15 | UF(II) 3815S | Regular (K170608) | | | | | 16 | UF(II) 3816S | | | | | 4.0 | 7 | UF(II) 4007S | | | | | | 8.5 | UF(II) 4008S | | | | | | 10 | UF(II) 4010S | | | | | | 11.5 | UF(II) 4011S | | | | | | 13 | UF(II) 4013S | | | | | | 15 | UF(II) 4015S | | | | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | | | 4.5 | 16 | UF(II) 4016S | | | | | | 7 | UF(II) 4507S | | | | | | 8.5 | UF(II) 4508S | | | | | | 10 | UF(II) 4510S | | | | | | 11.5 | UF(II) 4511S | | | | | | 13 | UF(II) 4513S | | | | | | 15 | UF(II) 4515S | | | | | | 16 | UF(II) 4516S | | | | | 5.0 | 7 | UF(II) 5007S | | | | | | 8.5 | UF(II) 5008S | | | | | | 10 | UF(II) 5010S | | | | | | 11.5 | UF(II) 5011S | | | | | | 13 | UF(II) 5013S | | | | | | 15 | UF(II) 5015S | | | | | | 16 | UF(II) 5016S | | | | | | | | | | | | 5.5 | 7 | UF(II) 5507S | | | | | | 8.5 | UF(II) 5508S | | | | | | 10 | UF(II) 5510S | | | | | | 11.5 | UF(II) 5511S | | | | | | 13 | UF(II) 5513S | | | | | | 15 | UF(II) 5515S | | | | | | 16 | UF(II) 5516S | | | | | | | | | | | | 6.0 | 7 | UF(II) 6007S | | | | | | 8.5 | UF(II) 6008S | | | | | | 10 | UF(II) 6010S | | | | | | 11.5 | UF(II) 6011S | | | | | | 13 | UF(II) 6013S | | | | | 6.5 | 7 | UF(II) 6507S | Wide (K173975) | | | | | 8.5 | UF(II) 6508S | | | | | | 10 | UF(II) 6510S | | | | | | 11.5 | UF(II) 6511S | | | | | | 13 | UF(II) 6513S | | | | | 7.0 | 7 | UF(II) 7007S | | | | | | 8.5 | UF(II) 7008S | | | | | | 10 | UF(II) 7010S | | | | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | | Neoss ProActive® (K083561) | 3.25 | 13 | UF(II) 7013S | 3.5 (NP) | Image: Internal Hex Connection | | | | 9 | 21176 | | | | | | 11 | 21177 | | | | | | 13 | 21178 | | | | | | 15 | 21179 | | | | | 3.5 | 7 | 21181 | | | | | | 9 | 21182 | | | | | | 11 | 21183 | | | | | | 13 | 21184 | | | | | | 15 | 21185 | | | | | | 17 | 21186 | | | | | 4.0 | 7 | 21187 | 4.0 (SP) | | | | | 9 | 21188 | | | | | | 11 | 21189 | | | | | | 13 | 21190 | | | | | | 15 | 21191 | | | | | | 17 | 21192 | | | | | 4.5 | 7 | 21193 | | | | | | 9 | 21194 | | | | | | 11 | 21195 | | | | | | 13 | 21196 | | | | | | 15 | 21197 | | | | | | 17 | 21198 | | | | | 5.0 | 7 | 21199 | | | | | | 9 | 21200 | | | | | | 11 | 21201 | | | | | | 13 | 21202 | | | | | | 15 | 21203 | | | | | | 17 | 21205 | | | | | 5.5 | 9 | 21206 | | | | | | 11 | 21207 | | | | | | 13 | 21208 | | | | | | 15 | 21211 | | | | | 6.0 | 9 | 21212 | | | | | | 11 | 21213 | | | | | | 13 | 21221 | | | | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | | | 3.0 | 15 | 21222 | | Image: Internal Hex connection | | | | 8.5 | TS3M3008S | 2.1 (Mini) | | | | | 10 | TS3M3010S | | | | | | 11.5 | TS3M3011S | | | | | | 13 | TS3M3013S | | | | | 3.5 (3.7) | 8.5 | TS3M3508S | | | | | | 10 | TS3M3510S | | | | | | 11.5 | TS3M3511S | | | | | | 13 | TS3M3513S | | | | | 4.0 (4.2) | 7 | TS3S4007S | | | | | | 8.5 | TS3S4008S | | | | | | 10 | TS3S4010S | | | | | | 11.5 | TS3S4011S | | | | | | 13 | TS3S4013S | | | | OSSTEM TS (K161604) | 4.5 (4.6) | 7 | TS3S4507S | | | | | | 8.5 | TS3S4508S | | | | | | 10 | TS3S4510S | | | | | | 11.5 | TS3S4511S | | | | | | 13 | TS3S4513S | | | | | 5.0 (5.1) | 7 | TS3S5007S | | | | | | | 8.5 | TS3S5008S | | | | | 10 | TS3S5010S | | | | | | 11.5 | TS3S5011S | | | | | | 13 | TS3S5013S | | | | | 6.0 (6.0) | 7 | TS3S6007S | | | | | | 8.5 | TS3S6008S | | | | | | 10 | TS3S6010S | | | | | | 11.5 | TS3S6011S | | | | | | 13 | TS3S6013S | | | | | 7.0 (6.8) | 7 | TS3S7007S | | | | | | 8.5 | TS3S7008S | | | | | | 10 | TS3S7010S | | | | | | 11.5 | TS3S7011S | | | | | | 13 | TS3S7013S | | | | | 3.3 | 11 | K1046.3311 | 3.3 | | | | | 13 | K1046.3313 | | | | Implant System | Implant Body Diameter (mm) | Implant Length (mm) | Model No. | Implant Platform Diameter (mm) | Type of Implant- Abutment Connection | | Camlog Screw-Line (K083496) | 3.8 | 16 | K1046.3316 | 3.8 | Tube-in-tube connection | | | 3.8 | 9 | K1046.3809 | | | | | 3.8 | 11 | K1046.3811 | | | | | 3.8 | 13 | K1046.3813 | | | | | 4.3 | 16 | K1046.3816 | 4.3 | | | | 4.3 | 9 | K1046.4309 | | | | | 4.3 | 11 | K1046.4311 | | | | | 4.3 | 13 | K1046.4313 | | | | Camlog Screw-Line (K083496) | 4.3 | 16 | K1046.4316 | 5.0 | | | 5.0 | 9 | K1046.5009 | | | | | 5.0 | 11 | K1046.5011 | | | | | 5.0 | 13 | K1046.5013 | | | | | 6.0 | 16 | K1046.5016 | 6.0 | |…