Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.
Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

Device Description

The Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments (collectively the "Custom Titanium Abutments") are one-piece hex type engaging abutments comprised of Titanium 6AL-4V ELI, which serve as a final abutment upon which a prosthetic dental restoration will be fitted.
The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices:

3Shape Abutment Design Software (K151455)
Dental System Control Panel
Dental Designer
Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, Product Code NOF)
Intra-oral scanners
3M True Definition Scanner (K122467)
Itero Scanner Software (K131101)
The Custom Abutments are patient-specific and may be modified within the following parameters:
Maximum angle of 30° from the axis of the implant
Minimum wall thickness of 0.4mm
Minimum post height of 4mm
The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing.
The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

AI/ML Overview

This document is related to a 510(k) premarket notification for dental implant abutments, which are physical medical devices, not AI/software-based devices. Therefore, the concepts of "acceptance criteria for an AI model," "study proving the device meets acceptance criteria" (in the context of algorithm performance), "test set," "training set," "ground truth establishment," "experts," "adjudication," and "MRMC studies" are not applicable here.

The document discusses performance data for the physical dental abutments, but this refers to traditional engineering and biological testing, not AI model validation.

Here's a breakdown of why your desired information isn't present in this document:

Device Type: The device is "Custom Legacy and Custom InterActive Titanium Abutments," which are physical, custom-milled dental prosthetics. They are not AI algorithms.
Study Purpose: The studies mentioned (Biocompatibility, Fatigue Testing, Steam Sterilization, Software Verification and Validation) are engineering and biological tests designed to ensure the physical device is safe and performs its mechanical function, and that the design software adheres to specified parameters. They are not studies to evaluate the diagnostic or predictive performance of an AI model.

However, I can extract information related to the device's technical specifications and how its engineering performance was validated:

Acceptance Criteria and Device Performance (in a physical device context):

The document details various non-clinical tests performed to support the device's safety and performance, acting as "acceptance criteria" for a physical medical device. The "reported device performance" is that the device passed these tests, indicating it performs as intended and is substantially equivalent to predicate devices.

Table of "Acceptance Criteria" and "Reported Device Performance" (adapted for a physical device K192218):

Acceptance Criterion (Test Performed)	Reported Device Performance
Biocompatibility (ISO 10993-1, -3, -5, -10, -11)	Worst-case Custom Abutments tested for Cytotoxicity, Sensitization, Irritation, Systemic toxicity, and Mutagenicity. Results: No adverse biological effects.
Fatigue Testing (ISO 14801)	Performed on worst-case scenario designs and implant-abutment loading configurations, considering maximum angulation (30 degrees), minimum wall thickness (0.4mm), minimum post height (4mm), and maximum overall length. Results: Performed successfully, implying durability under anticipated loads.
Steam Sterilization Validation (ISO 17665)	Performed on worst-case Custom Abutments (size, surface area, weight, lumen diameter considered). Results: Ensured a Sterility Assurance Level (SAL) of 10-6.
Software Verification and Validation (3Shape Abutment Designer™ Software K151455)	Testing for the off-the-shelf abutment design library used in the digital workflow. Results: Demonstrated that established design limitations are locked and cannot be modified by the end user within the abutment design library. (Ensures designs stay within validated parameters).

Regarding the other points, as they pertain to AI/ML, they are not applicable to this physical device submission:

Sample size for the test set and data provenance: Not applicable. This document refers to the number of physical abutment samples tested for biocompatibility and fatigue, not a test set for an AI model.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model's performance on medical images is irrelevant for this physical device.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which is not relevant here.
Standalone (algorithm only) performance: Not applicable. The device itself is a physical object; there's no "algorithm-only" performance to evaluate in this context. The software mentioned (3Shape Abutment Designer) is a design tool, not a diagnostic or predictive AI.
Type of ground truth used: Not applicable. Ground truth for AI (e.g., pathology, outcomes) is not relevant for testing the mechanical and biological properties of a dental abutment.
Sample size for the training set: Not applicable. There is no AI training set for this physical device.
How the ground truth for the training set was established: Not applicable.

In summary, this document thoroughly covers the engineering and biological validation required for a Class II physical medical device, demonstrating its substantial equivalence to predicate devices through well-defined tests, but it does not contain information about AI model validation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

May 8, 2020

Implant Direct Sybron Manufacturing, LLC % Kelliann Payne Partner Hogan Lovells U.S. LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K192218

Trade/Device Name: Custom Legacy and Custom InterActive Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: April 10, 2020 Received: April 10, 2020

Dear Kelliann Payne:

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.

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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.

Srinivas Nandkumar, Ph.D. for 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

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510(k) Number (if known) K192218

Device Name

Custom Leqacy and Custom InterActive Titanium Abutments

Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth . replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.

Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Leqacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.

Implant Line	Body Diameter	Platform Diameter	Implant Length
Legacy1	3.7mm, 4.2mm, 4.7mm, 5.7mm	3.5mm, 4.5mm, 5.7mm	8mm to 16mm
Legacy2, Legacy3, Legacy4,simplyLegacy2, simplyLegacy3	3.2mm, 3.7mm, 4.2mm, 4.7mm, 5.2mm, 5.7mm, 7.0mm	3.0mm, 3.5mm, 4.5mm, 5.7mm

Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

Implant Line	Body Diameter	Platform Diameter	Implant Length
InterActive, simplyInterActive	3.2mm, 3.7mm, 4.3mm, 5.0mm	3.0mm, 3.4mm	8mm to16mm
SwishActive	3.3mm, 4.1mm, 4.8mm	3.0mm, 3.4mm	8mm to16mm

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Implant Direct Sybron Manufacturing, LLC's Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments

Submitter:Address:Phone:Contact Person:	Implant Direct Sybron Manufacturing, LLC3050 East Hillcrest DriveThousand Oaks, CA 91362(818) 444-3306Reina Choi, Regulatory Affairs Manager
Date Prepared:	May 7, 2020
Name of Device:Common or Usual Name:Regulation Number:Classification Panel:Regulatory Class:Product Code:	Custom Legacy and Custom InterActive Titanium AbutmentsEndosseous dental implant abutments21 C.F.R. § 872.3630DentalClass IINHA
Predicate Device:	Implant Direct Sybron Manufacturing, LLC's Legacy AbutmentSystem (K060063)
Reference Devices:

lmplant Direct Sybron Manufacturing, LLC's InterActive/SwishPlus2 Implant System (K130572) 3Shape A/S's 3Shape Abutment Designer Software (K151455) Implant Direct Sybron Manufacturing, LLC's InterActive SMARTBase Abutments (K181359)

Device Description

The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices:

. 3Shape Abutment Design Software (K151455)
- о Dental System Control Panel
- Dental Designer o
Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, . Product Code NOF)
. Intra-oral scanners
- 3M True Definition Scanner (K122467) o
- Itero Scanner Software (K131101) o

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The Custom Abutments are patient-specific and may be modified within the following parameters:

Maximum angle of 30° from the axis of the implant .
. Minimum wall thickness of 0.4mm
. Minimum post height of 4mm

The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing.

The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

Intended Use / Indications for Use

. Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement ● of mandibular and maxillary central and lateral incisors.

Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.

Implant Line	Body Diameter	Platform Diameter	Implant Length
Legacy1	3.7mm, 4.2mm, 4.7mm, 5.7mm	3.5mm, 4.5mm, 5.7mm	8mm to 16mm
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3	3.2mm, 3.7mm, 4.2mm, 4.7mm, 5.2mm, 5.7mm, 7.0mm	3.0mm, 3.5mm, 4.5mm, 5.7mm

Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

Implant Line	Body Diameter	Platform Diameter	Implant Length
InterActive,simplyInterActive	3.2mm, 3.7mm, 4.3mm,5.0mm	3.0mm, 3.4mm	8mm to16mm
SwishActive	3.3mm, 4.1mm, 4.8mm	3.0mm, 3.4mm	8mm to16mm

The minor differences in indications for use of the Custom Abutments as compared to the predicate device do not alter the intended therapeutic effect of these devices or raise different questions of safety or effectiveness, as they are primarily intended for clarification of the appropriate conditions of use (e.g., compatibility) and to facilitate achievement of the same general intended use (in

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conjunction with dental implants to support crowns and bridges for edentulous or partially edentulous patients) via a digital dentistry workflow.

Summary of Technological Characteristics

Both the subject and predicate devices are based on the fundamental principle of providing support for (a) dental implant(s) in order to enable a dental restoration to be inserted into the patient's mouth to aid in rehabilitating a patient's chewing function. At a high level, the subject and predicate devices are based on the following same technological elements:

. Both subject devices and the predicate are one-piece abutments comprised of Titanium 6AL-4V ELI which can be modified to patient-specific requirements.
. Both subject devices and the predicate utilize a hex engaging feature that attaches to the reciprocal hex platform of the corresponding implant.
. Both subject devices and the predicate feature the same fundamental design (e.g., straight post for modifying custom features) and same corresponding screw size.

The Custom Abutments are available using either a Design-and-mill or Mill-only digital workflow, both of which employ the scanners identified in the Device Description section above and the 3Shape Abutment Designer Software (K151455).

The Design-and-mill workflow uses impression or intraoral scan data provided by the dental . practitioner as input for Implant Direct to design a Custom Abutment using 3Shape within its controlled facility. The resulting abutment design is approved by the dental practitioner and manufactured within the Implant Direct facility.
The Mill-only workflow allows the dental practitioner or dental laboratory staff to design the Custom Abutment using the 3Shape software. An encrypted .stl file is then transmitted to Implant Direct for manufacturing. A digital library provided by Implant Direct controls the abutment design parameters.

Thus, the main technological difference between the subject and predicate devices is the use of a digital workflow to modify the stock material of the subject devices into a final abutment, as compared to the conventional workflow used to modify/finalize the predicate abutment. This difference does not raise different questions of safety or effectiveness, because all of the devices are modified to clinician-prescribed, patient-specific parameters, and the same considerations apply around the safety and integrity of the final product under the anticipated loads in the mouth. In all cases with both the predicate and reference devices, as well as with the subject devices using either the Design-and-Mill or Mill-only workflows, the end user must approve the final abutment parameters/design. Moreover, the off-the-shelf software used to fabricate the Custom Abutments has been previously cleared by FDA (K151455) for use in producing abutments. The Custom InterActive Abutment has a slightly different connection to the implant than the predicate, but this connection supports the same functionality (mating between implant and abutment) and was previously cleared by FDA in the InterActive implant reference device (K130572).

A table comparing the key features of the subject and predicate devices is provided below.

Performance Data

Non-clinical testing was performed on the subject device to support its safety and performance. Successful test results indicate that the Custom Titanium Abutments will perform as intended and

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support the device's substantial equivalence, as summarized below.

Biocompatibility

The Custom Abutments were subjected to biocompatibility testing according to ISO 10993-1. Worstcase Custom Abutments were tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Systemic toxicity (ISO 10993-11), and Mutagenicity (ISO 10993-3). The testing showed no adverse biological effects.

Fatigue Testing

Fatigue testing was performed per ISO 14801. Testing was performed on worst-case scenario designs and implant-abutment loading configurations. The design parameters considered were maximum angulation (30 degrees), minimum wall thickness (0.4mm), minimum post height (4mm), and maximum overall length of abutment.

Steam Sterilization

Steam sterilization validation was performed per ISO 17665 on worst-case Custom Abutments, taking into consideration overall size, surface area, weight, and lumen diameter. The validation ensures an SAL of 10to.

Software Verification and Validation

Software verification and validation testing was performed for the off-the-shelf abutment design library used in the subject devices' digital workflow, 3Shape Abutment Designer™ Software (K151455). The testing demonstrated that the established design limitations are locked and cannot be modified by the end user within the abutment design library.

No animal or clinical testing was submitted in support of this 510(k) notice.

Conclusion

The Custom Legacy and Custom InterActive Titanium Abutments are as safe and effective as the predicate Legacy Abutment System (K060063). The Custom Titanium Abutments and previously cleared Legacy Scalloped (now called Straight Contoured) Abutment have the same intended use and very similar indications, technological characteristics, and principles of operation. The minor differences between the subject and predicate devices do not alter the therapeutic/surgical use of the device and do not present different questions of safety or effectiveness, because they do not represent fundamental differences in design or mechanism of action. In addition, performance data demonstrates that the subject Custom Abutments are as safe and effective as the predicate device. Thus, the Custom Titanium Abutments are substantially equivalent to the Legacy Abutment System.

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	Custom Titanium Abutments(Subject Device)	Legacy Abutment System(K060063)(Predicate Device)	InterActive SwishPlus2 ImplantSystem (K130572) (AbutmentComponent: Reference Device)	3Shape Abutment DesignerSoftware (K151455)(Reference Device)
Classification	21 CFR § 872.3630; Product Code NHA		21 CFR §§ 872.3640, 872.3630;Product Codes DZE, NHA	21 CFR § 872.3630; ProductCode PNP
Intended Use /Indications forUse	Custom Titanium Abutments arecustomizable devices intended for usewith dental implants in the maxillaryand/or mandibular arches to providesupport for crowns or bridges foredentulous or partially edentulouspatients.Custom Titanium Abutment for narrow (3.2mmD, 3.3.mD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements. Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.	The Legacy AbutmentSystem is intended for usewith dental implants in themaxillary and/or mandibulararches to provide support forcrowns, bridges, oroverdentures for edentulousor partially edentulouspatients.	The InterActive/SwishPlus2 ImplantSystem consists of two-piece implants forone-stage or two-stage surgicalprocedures. The abutment component ofthe system is included herein as areference device. These implants areintended for use in partially and fullyedentulous upper and lower jaws insupport of single or multiple-unitrestorations and terminal or intermediateabutment support for fixed bridgework:Implants can be indicated for immediateloading when good primary stability hasbeen achieved and with appropriateocclusal loading.Narrow Diameter (3.2, 3.3mm) Implants:Indicated for single-tooth replacement ofmandibular central and lateral incisorsand maxillary lateral incisors. Alsoindicated for multiple tooth replacementsor denture stabilization.	The 3Shape AbutmentDesigner Software is intendedas an aid to the restoration ofchewing function in partially orfully edentulous mandibles andmaxillae. The 3ShapeAbutment Designer Softwareis intended for use by a dentalpractitioner or dentallaboratory staff for designingthe patient specific componentof a two-piece, one-piece, orhybrid dental implantabutment. The single or multi-unit abutment design isintended to be used by themanufacturer of anendosseous dental implantabutment to create the finaldevice.
Compatibility	Custom Legacy Titanium Abutments arecompatible at the implant-level withLegacy1, Legacy2, Legacy3, Legacy4,simplyLegacy2 and simplyLegacy3implants, excluding 6mm lengthimplants.Custom InterActive Titanium Abutmentsare compatible at the implant-level withInterActive, SimplyInterActive andSwishActive implants, excluding 6mmlength implants.	The Legacy Abutment Systemis compatible with implantsthat have mating diameters,lead-in bevels, internal hexsizes, and 1-72UNF internalthreads, as shown in theZimmer Dental TaperedScrew-Vent Surgical Manual.Implant Direct LLC will monitorthe compatible implants formodifications to ensure futurecompatibility. In the event ofany modification, ImplantDirect LLC will either modifythe Legacy abutment toensure compatibility, or cease	InterActive and SwishPlus2 implants areprosthetically compatible with InterActive3.0 and 3.4mm abutments and NobelBiocare conical connection NobelActiveNP (Narrow Platform - 3.0mm diameter)and NobelActive RP (Regular Platform -3.4mm diameter) abutments. InterActive3.0 and 3.4mm abutments areprosthetically compatible with NobelBiocare conical connection. NobelActiveNP (Narrow Platform- 3.0mm diameter)and NobelActive RP (Regular Platform -3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.	N/A
	Custom Titanium Abutments(Subject Device)	Legacy Abutment System(K060063)(Predicate Device)	InterActive SwishPlus2 ImplantSystem (K130572) (AbutmentComponent: Reference Device)	3Shape Abutment DesignerSoftware (K151455)(Reference Device)
		claiming compatibility to the
		modified Zimmer Dental
		Screw-Vent implants.
Material		Titanium 6AL-4V ELI		N/A
General Design	One-piece abutment with hex engaging feature and straight post for modifying custom features			N/A - Software only device
Implant/Abutment Interface	Internal hex (Legacy) and Internal hexwith 12 degree conical lead-in bevel(InterActive)	Internal hex with 45 degreebevel	Internal hex with 12 degree conicallead-in bevel	N/A - Software only device
Implant/Abutmen	Legacy Model: 3.0mmD, 3.5mmD,4.5mmD, 5.7mmD	3.5mmD, 4.5mmD, 5.7mmD	3.0mmD, 3.4mmD	N/A - Software only device
t Interface
Diameters	InterActive Model: 3.0mmD, 3.4mmD
Cuff Diameters	3.2mm – 12.7mm	4.5mm, 5.4mm, 6.5mm	3.7mm, 4.7mm, 5.7mm	N/A - Software only device
ModifyingWorkflow	Customization design provided bycustomer or prepared in-house andthen machined in-house	Abutments are modified by outside laboratory and/or chairside by thedentist using hand instruments.		N/A


Screw Materialand Thread	Titanium alloy; M1.6, M2, 1-72UNF	Titanium alloy; 1-72 UNF	Titanium alloy; M1.6, M2	N/A
Single vs.Multiple Use	Single-use	Single-use	Single-use	Multiple use
Packaging	Packaged affixed via a fixation screw to a plastic screw-mount. The screw-mount is placed within a larger outer vial			N/A - Software only device
	and closed with a vial cap.
Sterilization	Sold non-sterile, Steam sterilization by end user		Sold non-sterile. Steam sterilization byend user after abutment modificationand prior to use.	Non-sterile

Substantial Equivalence Table

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Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)