ArgenIS Titanium Abutments
Device Facts
| Record ID | K143051 |
|---|---|
| Device Name | ArgenIS Titanium Abutments |
| Applicant | The Argen Corporation |
| Product Code | NHA · Dental |
| Decision Date | Sep 16, 2015 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.
Device Story
Patient-specific dental abutments milled from titanium blanks; interface pre-milled to match specific implant systems (Nobel Biocare, Biomet 3i, Straumann, Zimmer). Used by dental professionals in laboratory settings to support final prosthetic restorations. Device fixed to endosseous implant via included final prosthetic screw; lab screw provided for construction phase to protect final screw. Provides customized support for tissue, esthetics, and function. Benefits include patient-specific fit and compatibility with major implant platforms.
Clinical Evidence
Bench testing only. Included tolerance analysis for implant/abutment interface compatibility, functional fit checks (abutment blank to implant/analog/screw), and fatigue testing per ISO 14801 on worst-case samples (smallest diameter/shortest length).
Technological Characteristics
Material: Titanium-6AL-4V ELI alloy. Design: Patient-specific, milled abutment with pre-milled interface for specific implant platforms. Dimensions: 0-6mm gingival height, 3.5mm+ interface diameter, up to 12.5mm length, 0.65mm minimum wall thickness, 30° max angulation. Connection: Internal hex. Sterilization: Same as previously cleared Sterngold devices.
Indications for Use
Indicated for dental professionals (dentists/technicians) to construct dental restorations supported by endosseous dental implants for patients requiring prosthetic support for tissue, esthetics, and function.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
- Nobel Biocare Replace Select (K062566)
- Biomet 3i Certain (K130949)
- Straumann SynOcta (K081419)
- Zimmer Tapered Screw-Vent (K133339)
- Inclusive Titanium Abutment Blanks (K083192)
- SFI Bar® Implant Abutments for 7 Platforms (K130183)
- SFI Bar® Implant Abutments for 9 Platforms (K132814)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
The Argen Corporation c/o Ms. Maria Rao Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703
Re: K143051
> Trade/Device Name: ArgenIS Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 13, 2015 Received: August 17, 2015
Dear Ms. Rao:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K143051
Device Name: ArgenIS Titanium Abutments
# Indications for Use:
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.
The ArgenIS titanium abutments are compatible with the following implant systems:
| Implant Brand and Type | Implant Diameter | | | |
|------------------------------|------------------|--|--|--|
| Nobel Biocare Replace Select | 3.5mm | | | |
| Nobel Biocare Replace Select | 4.3mm | | | |
| Nobel Biocare Replace Select | 5.0mm | | | |
| Biomet 3i Certain | 3.25mm | | | |
| Biomet 3i Certain | 4.0mm | | | |
| Biomet 3i Certain | 5.0mm | | | |
| Straumann Tissue Level - RN | 3.3mm | | | |
| Straumann Tissue Level - RN | 4.1mm | | | |
| Straumann Tissue Level - RN | 4.8mm | | | |
| Zimmer Tapered Screw-Vent | 3.7mm | | | |
| Zimmer Tapered Screw-Vent | 4.1mm | | | |
| Zimmer Tapered Screw-Vent | 4.7mm | | | |
| Zimmer Tapered Screw-Vent | 6.0mm | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Part 21 CFR 801 Subparts D)
AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
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# 510(k) Summary
| Sponsor: | The Argen Corporation<br>5855 Oberlin Drive<br>San Diego, CA 92121 | | | |
|---------------------------------------------------------|--------------------------------------------------------------------|--|--|--|
| Contact: | Maria Rao, Regulatory Consultant<br>Phone: 401-871-3489 | | | |
| Date: | September 16, 2015 | | | |
| Trade Name: | ArgenIS Titanium Abutments | | | |
| Common Name: | Implant Abutment | | | |
| Classification Name: Endosseous Dental Implant Abutment | | | | |
| Classification: | 872.3630, Class II | | | |
| Product Code: | NHA | | | |
Legally Marketed Device to which Equivalence is claimed (Predicate Devices):
## Primary Predicate
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Nobel Biocare Replace Select K062566 872.3640 DZE Implant, Endosseous, Root-Form
#### Predicate Device No. 2
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
#### Predicate Device No. 3
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Biomet 3i Certain K130949 872.3640 DZE Implant, Endosseous, Root-Form
Straumann SynOcta K081419 872.3640 DZE Implant, Endosseous, Root-Form
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#### Predicate Device No. 4
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
#### Predicate Device No. 5
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
#### Predicate Device No. 6
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
#### Predicate Device No. 7
Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Zimmer Tapered Screw-Vent K133339 872.3640 DZE Implant, Endosseous, Root-Form
Inclusive Titanium Abutment Blanks K083192 872.3630 NHA Endosseous Dental Implant Abutment
SFI Bar® Implant Abutments for 7 Platforms K130183 872.3630 NHA Endosseous Dental Implant Abutment
SFI Bar® Implant Abutments for 9 Platforms K132814 872.3630 NHA Endosseous Dental Implant Abutment
#### Description of Device:
Argen IS Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Abutment is then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Abutment is supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw. The final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patientspecific form.
Minimum and Maximum Gingival Height is 0-6mm Minimum diameter at abutment/implant interface is 3.5mm to interface base Maximum length of abutment from abutment/implant interface is 12.5mm Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm Minimum wall thickness at abutment/implant interface is 0.65mm Maximal angle in relationship to the long axis of implant is 30°
The proposed ArgenIS Titanium Abutments are available in a range of diameters and connection type.
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| IMPLANT BRAND NAME | PLATFORM<br>CONNECTION | CYLINDER | CONNECTION TYPE |
|------------------------------|------------------------|-------------------|-----------------|
| Nobel Biocare Replace Select | 3.5mm | 17.225 - 17.275MM | Internal Hex |
| Nobel Biocare Replace Select | 4.3mm | 17.225 - 17.275MM | Internal Hex |
| Nobel Biocare Replace Select | 5.0mm | 17.225 - 17.275MM | Internal Hex |
| Biome 3i Certain | 3.4mm | 17.225 - 17.275MM | Internal Hex |
| Biomet 3i Certain | 4.1mm | 17.225 - 17.275MM | Internal Hex |
| Biomet 3i Certain | 5.0mm | 17.225 - 17.275MM | Internal Hex |
| Straumann Tissue Level | 4.8mm | 17.225 - 17.275MM | Internal Hex |
| Zimmer Tapered Screw-Vent | 3.5mm | 17.225 - 17.275MM | Internal Hex |
| Zimmer Tapered Screw-Vent | 4.5mm | 17.225 - 17.275MM | Internal Hex |
| Zimmer Tapered Screw-Vent | 5.7mm | 17.225 - 17.275MM | Internal Hex |
The available range of diameters and connection type is summarized below:
# Intended Use of the Device:
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.
The ArgenIS Titanium Abutments are compatible with the following implant systems:
| Implant Brand and Type | Implant Diameter |
|------------------------------|------------------|
| Nobel Biocare Replace Select | 3.5mm |
| Nobel Biocare Replace Select | 4.3mm |
| Nobel Biocare Replace Select | 5.0mm |
| Biomet 3i Certain | 3.25mm |
| Biomet 3i Certain | 4.0mm |
| Biomet 3i Certain | 5.0mm |
| Straumann Tissue Level - RN | 3.3mm |
| Straumann Tissue Level - RN | 4.1mm |
| Straumann Tissue Level - RN | 4.8mm |
| Zimmer Tapered Screw-Vent | 3.7mm |
| Zimmer Tapered Screw-Vent | 4.1mm |
| Zimmer Tapered Screw-Vent | 4.7mm |
| Zimmer Tapered Screw-Vent | 6.0mm |
# Technological Characteristics:
The Argen IS Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles, materials, technology and processes are the same as other Sterngold dental devices previously cleared by FDA. Substantial Equivalence:
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The Argen IS Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and materials are the predicate devices.
Compatibility and substantial equivalency was determined by comparing the design features including diameters, lengths, materials, implant-to-abutment connection platform and intended use of proposed devices to predicate devices.
Indications for Use and abutment design parameters are the same or similar to the predicate devices.
Any differences between proposed devices and predicate devices do not render the device NSE.
See Substantial Equivalence Comparison table below.
| Features | New Device | Primary<br>Predicate | Predicate 2 | Predicate 3 | Predicate 4 | Predicate 5 | Predicate 6 and 7 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ArgenIS Titanium<br>Abutment Blanks<br>The Argen<br>Corporation | Nobel Replace<br>Tapered Conical<br>Connection<br>Nobel Biocare<br>K062566 | CP4 Osseotite<br>Certain Dental<br>Implants<br>Biomet 3i<br>K130949 | Straumann<br>Dental Implant<br>System<br>Straumann<br>K081419 | Zimmer Dental<br>Tapered<br>ScrewVent<br>Implants<br>Zimmer Dental<br>K133339 | Inclusive Titanium<br>Abutment Blanks<br>Inclusive Dental<br>K083192 | SFI Implant<br>Abutments<br>Sterngold Dental<br>K130183 K132814 |
| Material | Titanium-6AL-4<br>Vanadium ELI Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy | Titanium-6AL-4<br>Vanadium ELI<br>Alloy |
| Prosthetic<br>Connection | Nobel Biocare<br>Replace Select<br>Biomet 3i Certain<br>Straumann SynOcta<br>Zimmer TSV | Nobel Replace<br>Tapered Conical<br>Abutments | Biomet 3i Certain<br>Abutments | Straumann ITI<br>Abutments<br>Straumann<br>SynOcta | Zimmer<br>Tappered Screw-<br>Vent Abutments | Nobel Active<br>Internal NP and RP<br>Straumann Bone<br>Level NC and RC<br>Nobel Branemark<br>RP | Nobel Biocare<br>Branemark Nobel<br>Biocare Replace<br>Biomet 3i Certain<br>Biomet 3i Osseotite<br>Zimmer TSV<br>Straumann SLA<br>Active Astra<br>OsseoSpeed |
| Indications for Use | See Indications for<br>Use Statement above | Intended to be<br>surgically placed<br>in the bone of<br>upper or lower<br>jaw arches to<br>provide support<br>for prosthetic<br>devices, such as<br>an artificial<br>tooth, in order to<br>restore patient<br>esthetics and<br>chewing<br>function. | Intended for<br>surgical placement<br>in the upper or<br>lower jaw to<br>provide a means<br>for prosthetic<br>attachment in<br>single tooth<br>restorations and in<br>partially or fully<br>edentulous patients | Intended for the<br>treatment of oral<br>endosteal<br>implantation in<br>the upper and<br>lower jaw and<br>for functional<br>and esthetic oral<br>rehabilitation of<br>edentulous and<br>partially dentate<br>patients. | Intended for use<br>in the maxilla or<br>mandible for<br>immediate<br>loading or for<br>loading after<br>conventional or<br>delayed healing<br>period. | Intended to be used<br>in conjunction with<br>endosseous implants<br>in the maxillary<br>and/or mandibular<br>arch to provide<br>support for crowns,<br>bridges or<br>overdenture<br>prostheses. | Intended to be used<br>with dental<br>implants to support<br>and/or retain<br>removable dental<br>prostheses for<br>partially or totally<br>edentulous patients<br>to restore chewing<br>function. |
| Platform<br>type/diameter,<br>abutment parameters | See Device<br>Description<br>above | Internal Hex;<br>3.5mm, 4.3, 5.0;<br>30° angulation | Internal Hex;<br>3.4mm, 4.1, 5.0;<br>30° angulation | Internal Hex;<br>4.8mm;<br>30° angulation | Internal Hex;<br>3.5mm, 4.5, 5.7;<br>30° angulation | Different<br>compatible<br>implant<br>platforms; 30°<br>angulation | No anti-rotation<br>design; multi-unit<br>systems only |
| Type of Retention | Screw-retained to<br>the implant. The<br>prosthesis can<br>be cement-retained<br>to the abutment. | Screw-retained to the<br>implant. The<br>prosthesis can<br>be cement-<br>retained to the<br>abutment. | Screw-retained to<br>the implant. The<br>prosthesis can<br>be cement-retained<br>to the abutment. | Screw-retained to the<br>implant. The<br>prosthesis can<br>be cement-<br>retained to the<br>abutment. | Screw-retained to<br>the implant. The<br>prosthesis can<br>be cement-<br>retained to the<br>abutment. | Screw-retained to<br>the implant. The<br>prosthesis can<br>be cement-retained<br>to the abutment. | Screw-retained to<br>the implant. The<br>prosthesis can<br>be cement-retained<br>to the abutment. |
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## Performance Data:
Bench testing was conducted to evaluate and determine conformance specifications and functionality according to its intended use.
Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant, analog and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance.
Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. One (1) implant size from each of the proposed platforms was tested per ISO 14801.
The Argen IS Abutments have the same sterilization process and parameters, and bio-compatibility as previous cleared Sterngold devices. As a result, they are substantial equivalent to its predicates.
## Substantial Equivalence
Non-clinical test data was used to support the substantially equivalence claim. The non-clinical testing consisted of tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant mating checks. The evaluation was based on FDA guidance "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
The summary of technological characteristics, tolerance analysis, and functional testing indicate that the device is substantially equivalent for its intended use and performs as well as the predicate devices.
#### Conclusion:
Based on the above analysis, technological characteristics and performance testing, the Argen IS Abutments are substantially equivalent in intended use, material, design and performance to its predicate devices.
The Argen IS Abutments do not create any new risks or increased risks compared to the predicate devices. The summary of technological characteristics and performance testing indicate that the device is substantially equivalent to its predicate devices.
