Who is the manufacturer of TruAbutment DS?

Truabutment, Inc. filed the 510(k) submission for TruAbutment DS (K191913).

What is the FDA product code for TruAbutment DS?

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?

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

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

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

K191913 · Truabutment, Inc. · NHA · Jun 19, 2020 · Dental

Device Facts

Record ID	K191913
Device Name	TruAbutment DS
Applicant	Truabutment, Inc.
Product Code	NHA · Dental
Decision Date	Jun 19, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: Biomet 3i 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 mm Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Story

TruAbutment DS is a patient-specific CAD/CAM abutment system; provides support for prosthetic restorations on endosseous dental implants. Input: patient-specific intra-oral data processed via CAD/CAM system. Operation: custom abutment design and manufacturing at validated milling center; abutment placed over implant shoulder and secured with titanium screw. Output: final patient-specific abutment. Used in dental clinics; operated by dental professionals. Benefits: provides customized prosthetic support for dental rehabilitation. Mechanical performance ensured via static compression and fatigue testing.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including static compression and compression fatigue testing per ISO 14801 and FDA guidance, dimensional analysis, and reverse engineering of implant-abutment interfaces.

Technological Characteristics

Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Connection: Internal hex. Manufacturing: CAD/CAM milling. Sterilization: Non-sterile (end-user steam sterilization). Dimensions: Patient-specific, compatible with specified OEM implant platforms.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via screw-retained restorations supported by endosseous dental implants. Compatible with specific Biomet 3i, DIO, Megagen, and Neoss implant systems.

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 (K170259)

Reference Devices

TruAbutment DS (K152559)
Zimmer® Patient Specific Abutment (K143505)
Biomet 3i Certain® (K130949)
DIO UF(II) Internal Submerged (K161987, K170608, K173975)
Megagen AnyRidge® (K140091)
Neoss ProActive® (K083561)

Related Devices

K170259 — TruAbutment DS · Truabutment · May 25, 2017
K201197 — TruAbutment DS, TruBase S · Truabutment, Inc. · Mar 26, 2021
K183106 — TruAbutment DS · Truabutment, Inc. · Jan 29, 2020
K203649 — TruAbutment DS, TruBase · Truabutment, Inc. · Sep 15, 2021
K213961 — TruAbutment DS, TruBase · Truabutment, Inc. · Jul 14, 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". June 19, 2020 TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614 Re: K191913 Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 19, 2020 Received: May 19, 2020 Dear Chris Choi: 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 (OS) 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. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191913 Device Name TruAbutment DS Indications for Use (Describe) The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: - · Biomet 3i 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 mm - Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm - · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm The available range of diameters is summarized below: Biomet 3i Certain® (K130949) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Megagen AnyRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary #### Submitter TruAbutment Inc. Kiyoon Nam 17742 Cowan, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488 ### Official Correspondent TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488 ## Device Information - Trade Name: TruAbutment DS, - Common Name: Endosseous dental implant abutment ● - Classification Name: Abutment, Implant, Dental, Endosseous . - . Product Code: NHA - Panel: Dental ● - Regulation Number: 21 CFR 872.3630 ● - Device Class: Class II ● - Date prepared: 06/19/2020 . ## Predicate Devices/Reference Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate - TruAbutment DS (K170259) . ### Reference Device - TruAbutment DS (K152559) ● - Zimmer® Patient Specific Abutment (K143505) ● - Biomet 3i Certain® (K130949) ● - . DIO UF(II) Internal Submerged (K161987, K170608, K173975) - Megagen AnyRidge® (K140091 - Neoss ProActive® (K083561) ● ### General Description The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: - (1) For fixing into the endosseous implant - (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of 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 and provided to the authorized end-user as a final patient-specific abutment. {5}------------------------------------------------ Mechanical resistance of the implant-abutment connection is essential to ensure 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 proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant. The available range of diameters is summarized below: | Implant System | Implant Ø (mm) | Implant Length (mm) | Model Number (mm) | Implant Platform (mm) | Type of Implant- Abutment Connection | |---------------------------------------------------------------------------------------|-------------------|------------------------|-------------------------|--------------------------|--------------------------------------------| | Biomet 3i Certain® (K130949) | 3.25 | 8.5 | IFNT3285 | 3.4 | Internal Hex | | | | 10 | IFNT3210 | | | | | | 11.5 | IFNT3211 | | | | | | 13 | IFNT3213 | | | | | | 15 | IFNT3215 | | | | 4.0 | 8.5 | IFNT485 | 4.1 | | | | | 10 | IFNT410 | | | | | | 11.5 | IFNT411 | | | | | | 13 | IFNT413 | | | | | | 15 | IFNT415 | | | | | 5.0 | 8.5 | IFNT585 | | | | | | 10 | IFNT510 | 5.0 | | | | | 11.5 | IFNT511 | | | | | | 13 | IFNT513 | | | | | | 15 | IFNT515 | | | | | 6.0 | 8.5 | IFNT685 | | 6.0 | | | | 10 | IFNT610 | | | | | | 11.5 | IFNT611 | | | | | | 13 | IFNT613 | | | | | | 15 | IFNT615 | | | | | DIO UF(II) Internal Submerged Implant (K161987) (K170608) (K173975) | 3.3 | 8.5 | UF(II)N3308 | Narrow (K161987) | Internal Hex | | | | 10 | UF(II)N3310 | | | | | | 11.5 | UF(II)N3311 | | | | | | 13 | UF(II)N3313 | | | | | | 15 | UF(II)N3315 | | | | | 3.8 | 8.5 | UF(II)3808S | Regular (K170608) | | | | 10 | UF(II)3810S | | | | | | | 11.5 | UF(II)3811S | | | | | | 13 | UF(II)38013 | | | | | | 15 | UF(II)38015 | | | | | | 16 | UF(II)3816S | | | | Implant System | Implant Ø (mm) | Implant Length (mm) | Model Number (mm) | Implant Platform (mm) | Type of Implant- Abutment Connection | | | 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 | | | | | | 16 | UF(II)4016S | | | | | 4.5 | 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 | Wide (K173975) | | | | | 13 | UF(II)6013S | | | | | 6.5 | 7 | UF(II)6507S | | | | | | 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 | | | | Implant System | Implant Ø (mm) | Implant Length (mm) | Model Number (mm) | Implant Platform (mm) | Type of Implant-Abutment Connection | | | | 10 | UF(II)7010S | | | | | | 11.5 | UF(II)7011S | | | | | | 13 | UF(II)7013S | | | | | | 3.5 | 8 | FANIHX3508 | | | | | | 10 | FANIHX3510 | | | | | | 11.5 | FANIHX3511 | | | | | | 13 | FANIHX3513 | | | | | 15 | FANIHX3515 | | | | | | 18 | FANIHX3518 | | | | | 4.0 | 8 | FANIHX4008 | | | | | | 10 | FANIHX4010 | | | | | | 11.5 | FANIHX4011 | | | | | | 13 | FANIHX4013 | | | | | | 15 | FANIHX4015 | | | | | | 18 | FANIHX4018 | | | | Megagen AnyRidge® (K140091) | 4.5 | 7 | FANIHX4508 | 3.1 | Internal Hex | | | | 8 | FANIHX4508 | | | | | | 10 | FANIHX4510 | | | | | | 11.5 | FANIHX4511 | | | | | | 13 | FANIHX4513 | | | | | | 15 | FANIHX4515 | | | | | | 18 | FANIHX4518 | | | | | 5.0 | 7 | FANIHX5007 | | | | | | 8 | FANIHX5008 | | | | | | 10 | FANIHX5010 | | | | | | 11.5 | FANIHX5011 | | | | | | 13 | FANIHX5013 | | | | | | 15 | FANIHX5015 | | | | | | 18 | FANIHX5018 | | | | | 5.5 | 7 | FANIHX5507 | | | | | | 8 | FANIHX5508 | | | | | | 10 | FANIHX5510 | | | | | | 11.5 | FANIHX5511 | | | | | | 13 | FANIHX5513 | | | | | | 15 | FANIHX5515 | | | | | | 18 | FANIHX5518 | | | | Neoss ProActive® (K083561) | 3.25 | 9 | 21176 | 3.5 | Internal Hex | | | | 11 | 21177 | | | | | | 13 | 21178 | | | | | | 15 | 21179 | | | | Implant System | Implant Ø (mm) | Implant Length (mm) | Model Number (mm) | Implant Platform (mm) | Type of Implant- Abutment Connection | | | 3.5 | 7 | 21181 | | | | | | 9 | 21182 | | | | | | 11 | 21183 | | | | | | 13 | 21184 | | | | | | 15 | 21185 | | | | | | 17 | 21186 | | | | | 4.0 | 7 | 21187 | | | | | | 9 | 21188 | | | | | | 11 | 21189 | | | | | | 13 | 21190 | | | | | | 15 | 21191 | | | | | | 17 | 21192 | | | | | 4.5 | 7 | 21193 | 4.0 | | | | | 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 | | | | | 6.5 | 9 | 21212 | | | | | | 11 | 21213 | | | | | | 13 | 21221 | | | | | | 15 | 21222 | | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Indication for Use The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: - · Biomet 3i 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 mm - • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm - · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm The available range of diameters is summarized below: Biomet 3i Certain® (K130949) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex ### Megagen AnvRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex ### Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture. {10}------------------------------------------------ ## Summary of Technological Characteristics The subject device is substantially equivalent to the creatingly equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Companison demonstating Substantial Equivalence follows at the end of this section. | Attributes | Proposed Device | Primary Predicate Device | Equivalence Discussion | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | TruAbutment DS (K191913) | TruAbutment DS (K170259) | | | Indications for Use | The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with following systems: • Biomet 3i 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 mm • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm • Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm The available range of diameters is summarized below: Biomet 3i Certain® (K130949) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Megagen AnyRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture. | The TruAbutment DS is a patient- specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes / Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm interface sizes All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture. | Equivalent The basic indication of providing support for prostheses is identical. The subject devices are compatible with the same CAD/CAM System as the primary predicate device | | Attributes | Proposed Device | Primary Predicate Device | Equivalence Discussion | | Trade Name | TruAbutment DS (K191913) | TruAbutment DS (K170259) | Equivalent | | Connection | Internal Hex…