(132 days)
No
The summary describes a dental abutment system and its associated digital workflow components (scanners, CAD/CAM software, milling machines). While it utilizes digital technology for design and fabrication, there is no mention or indication of AI or ML being used in any part of the process, such as image analysis, design optimization, or predictive modeling. The software used is described as a standard CAD design tool.
Yes
The device is a medical device intended to support dental prosthetic restorations, which is a therapeutic purpose.
No
Explanation: The Legacy™ SMARTBase Abutment system is a prosthetic device used to support dental restorations, not to diagnose a condition. It is designed for use in surgical and restorative procedures, integrating with digital dentistry workflows for the fabrication of patient-specific restorations.
No
The device is a physical dental implant abutment system comprised of titanium and zirconia components, not solely software. While it integrates with software for design and manufacturing, the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to be used in support of a dental implant to provide support for prosthetic restorations. This is a structural and mechanical function within the body, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details the physical components (titanium base, zirconia top, screws) and how they are used in a dental restoration workflow. It involves scanning, design software, and milling, all related to creating a physical prosthetic.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Performance Studies: The performance studies focus on mechanical strength, biocompatibility, sterilization, and software validation related to the design and fabrication of the abutment. These are not studies related to diagnostic accuracy or performance on biological samples.
IVD devices are specifically designed to perform tests on biological specimens to provide information for the diagnosis, treatment, or prevention of disease. This device serves a restorative purpose in dentistry.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
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 externally-communicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Fatigue 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.
- Biocompatibility evaluation was conducted according to ISO 10993-1 and FDA's corresponding June 2016 guidance, 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 10-6 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
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)
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.
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)
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, 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.
3
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
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
4
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.
5
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.
6
- 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).
7
| | Legacy SMARTBase
Abutment
(Subject Device) | InterActive SMARTBase
Abutment (K181359)
(Primary Predicate) | Spectra-System Dental
Implants 2008 (K090234)
(Reference Device) | 3Shape Software
(K151455)
(Reference Device) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. | InterActive/SwishActive Implant
System consists of two-piece
implants for one-stage or two- stage
surgical procedures. These implants
are intended for use in partially and
fully edentulous upper and lower
jaws in support of single or multiple-
unit restorations and terminal or
intermediate SMARTBase support
for fixed bridgework. The system
integrates multiple components of
the digital dentistry workflow: scan
files from Intra-Oral Scanners, CAD
software, CAM software, ceramic
material, milling machine and
associated tooling and accessories.
The SMARTBase Abutments consist
of two major parts. Specifically, the
titanium base and zirconia top
components make up a two- piece
abutment.
Implants can be indicated for
immediate loading when good
primary stability has been
achieved and with appropriate
occlusal loading.
• Narrow Diameter (3.2. 3.3mm)
Implants: Indicated for single- tooth
replacement of mandibular central
and lateral incisors and maxillary
lateral incisors. Also indicated for
multiple tooth replacements or
denture stabilization. | Spectra-System Dental
Implants 2008 are comprised of
dental implant fixtures and
prosthetic devices that
compose a two-piece implant
system. The implants are
intended for use in the
mandible and maxilla, in
support of single unit or multiple
unit cement or screw-receiving
restorations and for the
retention and support of
overdentures. The implants are
intended for immediate
placement and function for the
support of single tooth or
multiple- tooth restorations,
recognizing bone stability and
appropriate occlusal load
requirements. | The 3Shape Abutment
Designer Software is intended
as an aid to the restoration of
chewing function in partially or
fully edentulous mandibles and
maxillae. The 3Shape
Abutment Designer Software is
intended for use by a dental
practitioner or dental laboratory
staff for designing the patient
specific component of a two-
piece, one-piece, or hybrid
dental implant abutment. The
single or multi-unit abutment
design is intended to be used
by the manufacturer of an
endosseous dental implant
abutment to create the final
device. |
| Compatibility | • Implant Direct Legacy1: body
diameter 3.7 - 5.7mm, platform
diameter 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 SMARTBase
Abutment
(Subject Device) | InterActive SMARTBase
Abutment (K181359)
(Primary Predicate) | Spectra-System Dental
Implants 2008 (K090234)
(Reference Device) | 3Shape Software
(K151455)
(Reference Device) |
| | • Implant Direct Legacy2, 3, 4,
simplyLegacy2 & 3: body
diameter 3.2 - 7.0mm; platform
diameter 3.0, 3.5, 4.5, 5.7mm,
excluding 6mm length | (3.3, 4.1, 4.8mm body
diameter, 3.0 and 3.4mm
platform) | | |
| Prosthesis
Attachment | 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 |
| Abutment
Angulation | 0° to 30° | 0° to 30° | 0° to 30° | N/A |
| Abutment
Collar Heights | 0.25mm – 2mm | 1.0mm – 2.0mm | 1.0mm – 3.0mm | N/A |
| Post Height | | 4mm minimum | N/A | N/A |
| Abutment
material
and surface
treatment | | Titanium & Zirconia; abutments are titanium and anodized gold and pink (with
grooves machined for cement adhesion) | Titanium alloy | N/A |
| Cement
Adhesive | | EMBRACE (K071278) | N/A | N/A |
| Screw Material | | Titanium | Titanium | N/A |
| Implant
Interface
Platform | 3.0mm, 3.5mm, 4.5mm, and 5.7mm
platform diameter | 3.0mm and 3.4mm platform diameter | 3.0, 3.5, 4.5, and 5.7mm
diameter at the interface | N/A |
| Sterility | | Supplied non-sterile; steam sterilized by end user prior to use | Supplied non-sterile; steam
sterilized by end user prior to use | N/A |
| Number of
uses | | Single use | Single use | N/A |
Substantial Equivalence Table
8