(267 days)
No
The summary describes a digital workflow for designing and manufacturing custom dental abutments using existing software and scanning technologies. There is no mention of AI or ML being used in the design or manufacturing process.
No
Explanation: The device is an abutment for dental implants, providing structural support for crowns or bridges, rather than directly treating a disease or condition.
No
Explanation: The device is a "Custom Titanium Abutment" which is a prosthodontic device used to support crowns or bridges for dental implants. It is not described as being used to identify or diagnose a disease or condition.
No
The device is a physical dental abutment made of Titanium 6AL-4V ELI, which is a hardware component. While it utilizes software in its design and manufacturing workflow, the device itself is not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing support for crowns or bridges for edentulous or partially edentulous patients using dental implants. This is a structural and prosthetic function within the body.
- Device Description: The description details a physical implant abutment made of titanium, designed to be fitted to a dental implant. It describes a digital workflow for customization, but the final device is a physical component implanted in the patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is a medical device used within the body for a restorative purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
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 subject device to support its safety and performance. Successful test results indicate that the Custom Titanium Abutments will perform as intended and 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.
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 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
510(k) Number (if known) K192218
Device Name
Custom Leqacy and Custom InterActive Titanium Abutments
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, 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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3
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, LLC
3050 East Hillcrest Drive
Thousand Oaks, CA 91362
(818) 444-3306
Reina 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 Abutments
Endosseous dental implant abutments
21 C.F.R. § 872.3630
Dental
Class II
NHA |
| Predicate Device: | Implant Direct Sybron Manufacturing, LLC's Legacy Abutment
System (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 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)
- 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
4
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 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.
| 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
5
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
6
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.
7
| | Custom Titanium Abutments
(Subject Device) | Legacy Abutment System
(K060063)
(Predicate Device) | InterActive SwishPlus2 Implant
System (K130572) (Abutment
Component: Reference Device) | 3Shape Abutment Designer
Software (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; Product
Code PNP |
| Intended Use /
Indications for
Use | 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, 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 Abutment
System is intended for use
with dental implants in the
maxillary and/or mandibular
arches to provide support for
crowns, bridges, or
overdentures for edentulous
or partially edentulous
patients. | The InterActive/SwishPlus2 Implant
System consists of two-piece implants for
one-stage or two-stage surgical
procedures. The abutment component of
the system is included herein as a
reference device. 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
abutment support for fixed bridgework:
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. | 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 | Custom Legacy Titanium Abutments are
compatible at the implant-level with
Legacy1, 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. | The Legacy Abutment System
is compatible with implants
that have mating diameters,
lead-in bevels, internal hex
sizes, and 1-72UNF internal
threads, as shown in the
Zimmer Dental Tapered
Screw-Vent Surgical Manual.
Implant Direct LLC will monitor
the compatible implants for
modifications to ensure future
compatibility. In the event of
any modification, Implant
Direct LLC will either modify
the Legacy abutment to
ensure compatibility, or cease | InterActive and SwishPlus2 implants are
prosthetically compatible with InterActive
3.0 and 3.4mm abutments and Nobel
Biocare conical connection NobelActive
NP (Narrow Platform - 3.0mm diameter)
and NobelActive RP (Regular Platform -
3.4mm diameter) abutments. InterActive
3.0 and 3.4mm abutments are
prosthetically compatible with Nobel
Biocare conical connection. NobelActive
NP (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 Implant
System (K130572) (Abutment
Component: Reference Device) | 3Shape Abutment Designer
Software (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/Abutmen
t Interface | Internal hex (Legacy) and Internal hex
with 12 degree conical lead-in bevel
(InterActive) | Internal hex with 45 degree
bevel | Internal hex with 12 degree conical
lead-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 |
| Modifying
Workflow | Customization design provided by
customer or prepared in-house and
then machined in-house | Abutments are modified by outside laboratory and/or chairside by the
dentist using hand instruments. | | N/A |
| | | | | |
| | | | | |
| Screw Material
and 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 by
end user after abutment modification
and prior to use. | Non-sterile |
| | | | | |
| | | | | |
Substantial Equivalence Table
8