The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

. Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.

Device Description

The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.

The digital workflow includes the following products (not subject devices to this submission):

Ceramic material: Zenostar MT ●
Cement: EMBRACE Wetbond Resin Cement (K071278) ●
Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
. Abutment design software: 3Shape Abutment Designer™ Software (K151455)
Milling machine: Wieland-Zenotec Select & Zenotec CAM .

The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.

AI/ML Overview

This document describes Implant Direct Sybron Manufacturing, LLC's Legacy™ SMARTBase Abutments, a dental device intended to provide support for prosthetic restorations in partially edentulous patients. The FDA's 510(k) summary provides information on acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (based on predicate equivalence and established standards)	Reported Device Performance
Mechanical Strength (Fatigue)	Equivalency to the predicate device per ISO 14801:2016 (consistent with FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Abutments).	Results confirmed that the Legacy SMARTBase abutments perform equivalently to the predicate device. (Specific quantitative results, like fatigue limits, are not provided in this summary, but the general statement confirms meeting the equivalency criterion.)
Biocompatibility	Meet requirements according to ISO 10993-1 and FDA's corresponding June 2016 guidance for an externally-communicating device with permanent contact (>30 days) with patient bone/tissue/blood. Standards applied include ISO 10993-2, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and ISO 10993-33.	Demonstrated that the devices met biocompatibility requirements for its intended use. (Specific test results like cytotoxicity, irritation, or sensitization indices are not provided, but the statement indicates successful completion according to the standards.)
Cleaning and Steam Sterilization Validation	Attainment of a sterility assurance level (SAL) of 10^-6 using the same steam sterilization processes as the predicate device, according to ISO 14947 and ISO 17665-1.	Demonstrated attainment of a sterility assurance level of 10^-6 using the same steam sterilization processes as the predicate device. (Confirms the validated sterilization process achieves the required SAL.)
Software Validation (associated CAD/CAM system)	Ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specifications.	Ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specification. (States successful validation, relying on previous validation for the predicate device as the same software and milling unit are used.)
Intended Use / Indications for Use	Consistent with, or narrowing of, the predicate device's intended use and indications, without raising different questions of safety or effectiveness.	The Legacy SMARTBase Abutments have the same intended use and similar indications for use as the predicate. Differences either narrow its use or clarify appropriate conditions of use. The target population/conditions are fully encompassed by the predicate. Inclusion of lab scanners is an editorial change. Compatibility with the Legacy implant line (vs. InterActive for predicate) was previously cleared in a reference device. This indicates the device meets the functional equivalence criterion for its intended use.
Technological Characteristics	Similar technological elements to the predicate device, including two-piece abutments (titanium base, zirconia top), use in conventional/digital workflows, and similar fundamental design (size, diameter, post height). The main difference (abutment-implant interface) must be addressed by performance data.	Both the subject and predicate devices are two-piece abutments (titanium base, zirconia top), used in conventional and digital workflows with similar auxiliary devices, and feature the same fundamental design. Performance data (fatigue testing) specifically addressed the abutment-implant interface difference by showing equivalency to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each non-clinical test (mechanical fatigue, biocompatibility, sterilization validation). However, it mentions that dynamic fatigue testing was performed on "worst-case device configurations" per ISO 14801:2016.

Test Set Sample Size: Not explicitly stated for each test, but "worst-case device configurations" were used for fatigue testing.
Data Provenance: The studies are non-clinical (laboratory testing) performed internally by the manufacturer or by third-party labs following international standards (ISO) and FDA guidance. The country of origin of the data is not specified beyond being part of the manufacturer's submission to the FDA. The data is prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies are non-clinical, laboratory-based tests for physical, chemical, and biological properties of the device. There is no human "test set" requiring expert ground truth establishment in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is geared towards AI/software performance. While software validation was performed for the associated CAD/CAM software, it is not an "algorithm only" performance study in the typical sense of AI diagnostics. The software (3Shape Abutment Designer Software) is a design tool for the abutment, not a standalone diagnostic or predictive algorithm. Its validation "ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments." This implies a validation of its function within the design workflow, rather than a standalone performance metric for a decision-making algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

Mechanical Strength (Fatigue): Ground truth is established by the specified loads and cycles in ISO 14801:2016 and the equivalency standard to the predicate device. The "ground truth" is a pass/fail against these engineering standards.
Biocompatibility: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards.
Sterilization Validation: Ground truth is established by achieving a verified sterility assurance level of 10^-6 according to ISO 14947 and ISO 17665-1.
Software Validation: Ground truth is established by the software's ability to "successfully create abutments employing 3Shape software within established design limitations and specification." This refers to functional correctness and adherence to design parameters.

8. The Sample Size for the Training Set

This document does not describe the development or training of an AI algorithm in the traditional sense, so there is no training set sample size mentioned. The CAD/CAM software mentioned (3Shape Abutment Designer Software) is an off-the-shelf product with an existing design library, not something that appears to have been "trained" by this manufacturer on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit training set for an AI algorithm described for the device itself, this question is not applicable. The software validation relies on the established functional specifications and design limitations of the 3Shape software and Implant Direct's abutment design library.

Summary

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October 10, 2019

Implant Direct Sybron Manufacturing LLC % Yarmela Pavlovic Partner Hogan Lovells U.S. LLP 3 Embarcadero Center #1500 San Francisco, California 94111

Re: K191458

Trade/Device Name: Legacy™ SMARTBase Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: September 10, 2019 Received: September 10, 2019

Dear Yarmela Pavlovic:

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known) K191458 Device Name

Legacy™ SMARTBase Abutments

Indications for Use (Describe)

. Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.

Compatibility

Legacy SMARTBase engaging abutments are compatible at the implant level with Legacy (3.0mm, 3.5mm, 4.5mm and 5.7mm platform diameter) 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, 10mm, 11.5mm, 13mm, 16mm
Legacy2, 3, 4, simplyLegacy2,simplyLegacy3	3.2mm, 3.7mm, 4.2mm, 4.7mm, 5.2mm, 5.7mm, 7.0mm	3.0mm, 3.5mm, 4.5mm, 5.7mm	16mm

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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K191458

510(k) SUMMARY

Implant Direct Sybron Manufacturing, LLC's Legacy SMARTBase Abutments

Submitter

Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362

Phone: 818-444-3306

Contact Person: Reina Choi, Regulatory Affairs Manager

Date Prepared: October 9, 2019

Name of Device: Legacy™ SMARTBase Abutments

Classification Name: Endosseous Dental Implant Abutment (21 C.F.R. § 872.3630)

Regulatory Class: Class II

Primary Product Code: NHA

Secondary Product Code: PNP

Primary Predicate: Implant Direct Sybron Manufacturing, LLC's InterActive SMARTBase Abutments (K181359)

Reference Devices: Implant Direct Sybron Manufacturing, LLC's Spectra-System Dental Implants 2008 (K090234); 3Shape A/S's 3Shape Abutment Designer Software (K151455)

Device Description

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Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.

The digital workflow includes the following products (not subject devices to this submission):

Ceramic material: Zenostar MT ●
Cement: EMBRACE Wetbond Resin Cement (K071278) ●
Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
. Abutment design software: 3Shape Abutment Designer™ Software (K151455)
Milling machine: Wieland-Zenotec Select & Zenotec CAM .

The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.

Intended Use / Indications for Use

The Legacy SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTbase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth . replacement of mandibular central and lateral incisors and maxillary lateral incisors.
. Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.

Compatibility

Legacy "" SMARTBase engaging abutments are compatible at the implant level with Legacy (3.0mm, 3.5mm, 4.5mm and 5.7mm platform diameter) 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, 10mm,11.5mm, 13mm,16mm
Legacy2, 3, 4, simplyLegacy2,simplyLegacy3	3.2mm, 3.7mm, 4.2mm, 4.7mm,5.2mm, 5.7mm, 7.0mm	3.0mm, 3.5mm,4.5mm, 5.7mm

The Legacy SMARTBase Abutments have the same intended use as the predicate InterActive SMARTBase Abutments, namely to aid in prosthetic rehabilitation by anchoring/supporting a restoration to a dental implant.

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The Legacy SMARTBase Abutments also have similar indications for use as the predicate device and the differences do not alter the fundamental therapeutic/surgical use of the device because they either narrow its use as compared to the predicate or serve to clarify appropriate conditions of use. While the predicate device is more broadly indicated for use in both partially and fully edentulous patients, and accordingly can be used to support multi-unit restorations in addition to single-unit restorations, the target population/conditions to be treated with the Legacy SMARTBase Abutments are fully encompassed by those of the predicate device.

Additionally, the indications for use include reference to the lab scanners used with the SMARTBase Abutments. This component is also used with the previously cleared CAD/CAM system and was assessed in the previously performed CAD/CAM software verification and validation, which support both the primary predicate and the subject device. Therefore, the inclusion of the lab scanners is merely an editorial change for clarity and does not raise different questions of safety or effectiveness.

The other main difference between the two indications statements is that the predicate is compatible with the company's InterActive dental implant line as opposed to the Legacy implant line. This difference also does not raise different questions of safety or effectiveness when the device is used as labeled, because the same abutment compatibility with the company's Legacy implant line has previously been cleared in the reference device.

Summary of Technological Characteristics

Both the subject and predicate devices are based on the funciple of providing support for dental implants in order to enable a dental restoration to be inserted into the patient's mouth and rehabilitate a patient's chewing function. At a high level, the subject and predicate devices are based on the following same technological elements:

. Both are two-piece abutments comprised of a Titanium base and a zirconia top which can be modified to patient-specific requirements.
. Both are used in the conventional and digital workflows, with similar auxiliary devices, to facilitate fabrication of a patient-specific dental restoration.
. Both feature the same fundamental design (e.g., size and diameter ranges, post height).

The main technological difference between the subject and predicate devices is the abutment- implant interface: The subject device mates with the Legacy implant line whereas the predicate device mates with the InterActive implant line.

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

Performance Data

Non-clinical testing was performed on the proposed device, including mechanical strength (fatigue), biocompatibility, cleaning and steam sterilization validation, and software verification. Successful test results indicated that the Legacy SMARTBase Abutments will perform as intended, and support the device's substantial equivalence.

. Dynamic Fatique testing on the worst-case device configurations per ISO 14801;2016 (consistent with, FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments). Results confirmed that the Legacy SMARTBase abutments perform equivalently to the predicate device.

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Biocompatibility evaluation was conducted according to ISO 10993-1 and FDA's corresponding ● June 2016 quidance, for an externally-communicating device with permanent (>30 day) contact with patient bone/tissue/blood. Tested was performed in accordance with the following standards: ISO 10993-2, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12 and ISO 10993-33 to demonstrate that the devices met biocompatibility requirements for its intended use.
The proposed devices are provided non-sterile and intended to be steam sterilized by the end user. Steam sterilization validation according to ISO 14947 and ISO 17665-1 to demonstrate attainment of a sterility assurance level of 10° using the same steam sterilization processes as the predicate device.
. Software validation ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specification and validation testing performed in support of the previously cleared InterActive SMARTBase Abutments (K181359) was also relied upon as the subject device employs the identical off-the-shelf abutment designer software and milling unit.

Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product.

Conclusion

The Legacy SMARTBase Abutments have the same intended use and principles of operation, and similar indications for use and technological characteristics, as its predicate device. The minor differences in indications do not alter the intended therapeutic/surgical use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Legacy SMARTBase Abutment system and its predicate device raise no new issues of safety or effectiveness, and have been further addressed by performance data which demonstrates that the device performs in a substantially equivalent manner as the predicate device. Thus, the Legacy SMARTBase Are substantially equivalent to the predicate InterActive SMARTBase Abutment System (K181359).

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	Legacy SMARTBaseAbutment(Subject Device)	InterActive SMARTBaseAbutment (K181359)(Primary Predicate)	Spectra-System DentalImplants 2008 (K090234)(Reference Device)	3Shape Software(K151455)(Reference Device)
Intended Use /Indications forUse	The Legacy SMARTBase Abutmentsystem is designed to be used insupport of a dental implant(s) to providesupport for prosthetic restorations in apartially edentulous patient.Legacy SMARTBase engagingabutments are intended for use in themandible or maxilla in support of singleunit restorations.The Legacy SMARTBase Abutmentsystem integrates multiple componentsfor use in both a traditional and digitaldentistry workflow: scan files from Intra-oral Scanners and lab scanners, CADsoftware, CAM software, ceramicmaterial, milling machine andassociated tooling and accessories. TheLegacy SMARTBase system consist oftwo major parts: the titanium base andzirconia top components make up a two-piece abutment.• Legacy SMARTBase abutmentfor narrow (3.2mmD) implants:Indicated for single-toothreplacement of mandibularcentral and lateral incisors andmaxillary lateral incisors.• Legacy SMARTBase abutmentfor short (8mm) 3.7mmDimplants: Indicated for toothreplacement of mandibular andmaxillary central and lateralincisors.	InterActive/SwishActive ImplantSystem consists of two-pieceimplants for one-stage or two- stagesurgical procedures. These implantsare intended for use in partially andfully edentulous upper and lowerjaws in support of single or multiple-unit restorations and terminal orintermediate SMARTBase supportfor fixed bridgework. The systemintegrates multiple components ofthe digital dentistry workflow: scanfiles from Intra-Oral Scanners, CADsoftware, CAM software, ceramicmaterial, milling machine andassociated tooling and accessories.The SMARTBase Abutments consistof two major parts. Specifically, thetitanium base and zirconia topcomponents make up a two- pieceabutment.Implants can be indicated forimmediate loading when goodprimary stability has beenachieved and with appropriateocclusal loading.• Narrow Diameter (3.2. 3.3mm)Implants: Indicated for single- toothreplacement of mandibular centraland lateral incisors and maxillarylateral incisors. Also indicated formultiple tooth replacements ordenture stabilization.	Spectra-System DentalImplants 2008 are comprised ofdental implant fixtures andprosthetic devices thatcompose a two-piece implantsystem. The implants areintended for use in themandible and maxilla, insupport of single unit or multipleunit cement or screw-receivingrestorations and for theretention and support ofoverdentures. The implants areintended for immediateplacement and function for thesupport of single tooth ormultiple- tooth restorations,recognizing bone stability andappropriate occlusal loadrequirements.	The 3Shape AbutmentDesigner Software is intendedas an aid to the restoration ofchewing function in partially orfully edentulous mandibles andmaxillae. The 3ShapeAbutment Designer Software isintended for use by a dentalpractitioner or dental laboratorystaff for designing the patientspecific component of a two-piece, one-piece, or hybriddental implant abutment. Thesingle or multi-unit abutmentdesign is intended to be usedby the manufacturer of anendosseous dental implantabutment to create the finaldevice.
Compatibility	• Implant Direct Legacy1: bodydiameter 3.7 - 5.7mm, platformdiameter 3.5, 4.5, 5.7mm 3.5,4.5, 5.7mm;	• Implant Direct interactive (3.2,3.7, .3, 5.0mm body diameter,3.0 and 3.4mm)• Implant Direct SwishActive	N/A	N/A
	Legacy SMARTBaseAbutment(Subject Device)	InterActive SMARTBaseAbutment (K181359)(Primary Predicate)	Spectra-System DentalImplants 2008 (K090234)(Reference Device)	3Shape Software(K151455)(Reference Device)
	• Implant Direct Legacy2, 3, 4,simplyLegacy2 & 3: bodydiameter 3.2 - 7.0mm; platformdiameter 3.0, 3.5, 4.5, 5.7mm,excluding 6mm length	(3.3, 4.1, 4.8mm bodydiameter, 3.0 and 3.4mmplatform)
ProsthesisAttachment	Screw- or cement-retained	Screw- or cement-retained	Screw- or cement-retained	N/A
Restoration	Single-unit	Single-unit and multi-unit	Single-unit and multi-unit	Single-unit and multi-unit
AbutmentAngulation	0° to 30°	0° to 30°	0° to 30°	N/A
AbutmentCollar Heights	0.25mm – 2mm	1.0mm – 2.0mm	1.0mm – 3.0mm	N/A
Post Height		4mm minimum	N/A	N/A
Abutmentmaterialand surfacetreatment		Titanium & Zirconia; abutments are titanium and anodized gold and pink (withgrooves machined for cement adhesion)	Titanium alloy	N/A
CementAdhesive		EMBRACE (K071278)	N/A	N/A
Screw Material		Titanium	Titanium	N/A
ImplantInterfacePlatform	3.0mm, 3.5mm, 4.5mm, and 5.7mmplatform diameter	3.0mm and 3.4mm platform diameter	3.0, 3.5, 4.5, and 5.7mmdiameter at the interface	N/A
Sterility		Supplied non-sterile; steam sterilized by end user prior to use	Supplied non-sterile; steamsterilized by end user prior to use	N/A
Number ofuses		Single use	Single use	N/A

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.)