Who is the manufacturer of ArgenIS Titanium Abutments?

Argen Corporation filed the 510(k) submission for ArgenIS Titanium Abutments (K160248).

What is the FDA product code for ArgenIS Titanium Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ArgenIS Titanium Abutments?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like ArgenIS Titanium Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ArgenIS Titanium Abutments

K160248 · Argen Corporation · NHA · Aug 5, 2016 · Dental

Device Facts

Record ID	K160248
Device Name	ArgenIS Titanium Abutments
Applicant	Argen Corporation
Product Code	NHA · Dental
Decision Date	Aug 5, 2016
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

Device Story

ArgenIS Titanium Abutments are patient-specific dental abutments milled from Titanium-6AL-4V ELI alloy. The process begins with digital design files sent to the Argen manufacturer, which are then milled to create a custom abutment with a pre-milled interface matching specific implant systems. The device is used in dental laboratories and clinics; it is fixed to the endosseous implant using a prosthetic screw. The system includes a final screw for clinical use and a lab screw for construction to prevent damage to the final component. The abutment supports the final prosthetic restoration, aiding in the restoration of dental function and aesthetics. It is intended for single use by prescription only.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included tolerance analysis for implant/abutment interface compatibility, dimensional verification, and functional fit checks. Fatigue testing was performed on worst-case samples (smallest diameter/shortest length) per ISO 14801. Biocompatibility and sterilization parameters were leveraged from previously cleared Sterngold devices.

Technological Characteristics

Material: Titanium-6AL-4V ELI alloy. Design: Patient-specific, machined. Interface: Pre-milled to match specific implant platforms (Nobel Biocare, Straumann, Astra Tech). Dimensions: Gingival height 0-6mm, post length >=4.0mm, wall thickness >=0.65mm, angulation up to 30°. Sterilization: Moist heat (steam). Connectivity: Digital file submission for manufacturing.

Indications for Use

Indicated for use in patients requiring dental restorations supported by endosseous dental implants. The device is a patient-specific abutment used to support prosthetic restorations (e.g., crowns, bridges).

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

ArgenIS (K143051)

Reference Devices

Nobel Biocare Replace (K022424)
Nobel Biocare Active (K102436, K071370, K142260)
Straumann Bone Level (K083550, K121131)
Straumann Dental Implant System (K033243)
Astra Tech Implants OsseoSpeed (K024111)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 5, 2016 Argen Corporation % Ms. Maria Rao Regulatory Consultant Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703 Re: K160248 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: June 30, 2016 Received: July 1, 2016 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. {1}------------------------------------------------ Page 2 - Ms. Maria Rao 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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): Device Name: ArgenIS Titanium Abutments ### Indications for Use: ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems: | IMPLANT BRAND NAME | PLATFORM | Manufacturer | Implant Trade Name | Implant Line/Connection | Implant Diameter | |---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------| | Nobel Biocare Replace Select | 6.0mm | Nobel Biocare USA | Nobel Replace Tapered Conical Connection | Nobel Replace Internal Conical Connection WP | 6.0mm | | Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive Internal Connection Implant | Nobel Active Internal Conn. RP and NP | 3.0, 3.5, 4.3, 5.0mm | | Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive Internal Connection Implant | Nobel Active Internal Conn. RP and NP | 3.0, 3.5, 4.3, 5.0mm | | Straumann Bone Level | 3.3mm | Straumann USA | Straumann Bone Level Tapered Implants | Bone Level Internal Conn. NC | 3.3mm | | Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann Bone Level Tapered Implants | Bone Level Internal Conn. RC | 4.1, 4.8mm | | Straumann Synocta | 4.8mm | Institut Straumann AG | Straumann Dental Implant | Synocta Implant Internal Conn. 4.8mm RN (Reg. Neck) | 4.8, 6.5mm | | Straumann Synocta | 6.5mm | Institut Straumann AG | Straumann Dental Implant | Synocta Implant Internal Conn. 6.5mm (Wide Neck) | 4.8, 6.5mm | | Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech Implant OsseoSpeed | OsseoSpeed Internal Conical Connection RP | 3.6, 4.2, 4.8mm | | Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech Implant OsseoSpeed Plus | OsseoSpeed Plus Internal Conical Connection RP | 3.0, 3.5, 4.0, 4.5, 5.0mm | {3}------------------------------------------------ ## (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) {4}------------------------------------------------ ### 510(k) Summary - 1. Sponsor: The Argen Corporation 5855 Oberlin Drive San Diego, CA 92121 - 2. Contact: Paul Cascone Senior Vice-President of Research & Development Phone: 858-455-7900 - 3. Date: August 3, 2016 - 4. Trade Name: ArgenIS Titanium Abutments - 5. Common Name: Implant Abutment - 6. Classification Name: Endosseous Dental Implant Abutment - 7. Classification: 872.3630, Class II - 8. Product Code: NHA - 9. Legally Marketed Device to which Equivalence is claimed (Predicate Devices): #### 9.1 Primary Predicate: Trade Name: ArgenIS 510(k) Number: K143051 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment #### 9.2 Reference Device No. 2 Trade Name: Nobel Biocare Replace 510(k) Number: K022424 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form #### 9.3 Reference Device No. 3 Trade Name: Nobel Biocare Active 510(k) Number: K102436, K071370, K142260 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form {5}------------------------------------------------ #### 9.4 Reference Device No. 4 Trade Name: Straumann Bone Level 510(k) Number: K083550, K121131 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form #### 9.5 Reference Device No. 5 Trade Name: Straumann Dental Implant System 510(k) Number: K033243 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form #### 9.6 Reference Device No. 6 Trade Name: Astra Tech Implants OsseoSpeed 510(k) Number: K024111 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: Endosseous Dental Implant Abutment ### 10.0 Description of Device: Argen IS Titanium 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 Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are 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 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 patient specific 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 available range of diameters and connection type is summarized on the table below: {6}------------------------------------------------ ### 11. Intended Use ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems: | IMPLANT BRAND NAME | PLATFORM | Manufacturer | Implant Trade Name | Implant Line/Connection | Implant Diameter | |------------------------------|-----------|-----------------------|------------------------------------------|----------------------------------------------------------|----------------------| | Nobel Biocare Replace Select | 6.0mm | Nobel Biocare USA | Nobel Replace Tapered Conical Connection | Nobel Replace Internal Conical Connection WP | 6.0mm | | Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive Internal Connection Implant | Nobel Active Internal Connection RP and NP | 3.0, 3.5, 4.3, 5.0mm | | Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive Internal Connection Implant | Nobel Active Internal Connection RP and NP | 3.0, 3.5, 4.3, 5.0mm | | Straumann Bone Level | 3.3mm | Straumann USA | Straumann Bone Level Tapered Implants | Bone Level Internal Connection NC | 3.3mm | | Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann Bone Level Tapered Implants | Bone Level Internal Connection RC | 4.1, 4.8mm | | Straumann Synocta | 4.8mm | Institut Straumann AG | Straumann Dental Implant | Synocta Implant Internal Connection 4.8mm RN (Reg. Neck) | 4.8, 6.5mm | | Straumann Synocta | 6.5mm | Institut Straumann AG | Straumann Dental Implant | Synocta Implant Internal Connection 6.5mm (Wide Neck) | 4.8, 6.5mm | | Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech U.S.A. | AstraTech Implant OsseoSpeed | OsseoSpeed Internal Conical Connection RP | 3.5/4.0mm | | Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech U.S.A. | AstraTech Implant System OsseoSpeed | OsseoSpeed Plus Internal Conical Connection RP | 4.5/5.0mm | {7}------------------------------------------------ ### 12. Technological Characteristics The Argen IS Titanium Abutments are substantially equivalent to the currentlmarketed 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. ### 13. Substantial Equivalence The Argen IS Titanium Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, basic design, fundamental operating principles and materials are the same as 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. Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device. Any differences between the proposed devices and predicate devices do not render the device NSE. See Substantial Equivalence Comparison table below. ## 14. Performance Data Bench testing was conducted to evaluate and determine conformance to performance 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 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. The worst case scenarios from each of the proposed platforms were tested per ISO 14801. The Argen IS Titanium Abutments have the same sterilization process and parameters, and biocompatibility as previous cleared Sterngold devices. As a result, they are substantial equivalent to its predicates. No changes were made that would affect the bio-compatibility and sterilization validation previously conducted. 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. ### 15. Conclusion Based on the above analysis, technological characteristics and performance testing, the Argen IS Titanium Abutments are substantially equivalent in intended use, material, design and performance to its predicate devices. The Argen IS Titanium 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. {8}------------------------------------------------ # The Argen Corporation Abbreviated 510(k) Premarket Notification # ArgenIS Titanium Abutment Blanks | Features | New Device | Primary Predicate | Reference 2 | Reference 3 | Reference 4 | Reference 5 | Reference 6 | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ArgenIS Titanium Abutments The Argen Corporation | Argen IS Titanium Abutments K143051 The Argen Corporation | Nobel Replace Tapered Conical Connection Nobel Biocare U.S.A. K022424 | Nobel Active Implants Nobel Biocare US.A. K102436, K071370, K142260 | Straumann Bone Level K083550, K121131 Straumann USA | Synocta Implants K033243 Straumann USA | Astra Tech Implants OsseoSpeed K024111 Astra Tech | | Material | Titanium-6AL-4 Vanadium ELI Alloy | Titanium-6AL-4 Vanadium ELI Alloy | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium | | Prosthetic Connection | Nobel Biocare Replace Select 6.0mm Nobel Biocare Active Straumann Bone Level, Straumann Synocta, Astra Tech OsseoSpeed | Nobel Biocare Replace Select Biomet 3i Certain Straumann SynOcta Zimmer Tapered Screw- Vent | Nobel Replace Tapered Conical Abutments | Nobel Biocare Active | Straumann Bone Level | Straumann SynOcta | Astra OsseoSpeed 3.5/4.0mm and 4.5/5.0mm | | Indications for Use | ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseuos dental implant. The ArgenIs Titanium abutments are designed to specifically fit an individual patient's needs of final restoration. All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. | ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the constructions of dental restorations supported by endosseuos dental implants. The Argen IS Abutment is designed to specifically fit an individual pateints needs in order to more naturally support the tissue, esthetics, and functions of the final restoration. | The Replace HA Coated Implant is both for single-stage or two- stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. Multiple tooth applications may be splinted with a bar. . | Intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. | Intended for the treatment of oral endosteal implantation in the upper and lower jaw and for functional and esthetic oral rehabilitation of edentulous and partially dentate patients. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstruction such as crowns or bridges. The ITI synOcta Measo abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations. | Intended for endosseous implantation in the mandible and maxilla supporting single-tooth replacements, partial and total fixed/fixed detachable bridges and overdentures. One or two stage surgical procedure can be used. When using one stage surgical protocol, immediate loading may be applied in the anterior mandibular region if at least four implants are splinted with a bar, or a continuous suprastructure. | | Implant Diameters, Lengths | 3.3mm , 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm | 3.25mm - 6.0mm | Diameters 3.5mm, 4.3mm, 5.0mm, 6.0mm Lengths 10mm, 13mm, 16mm | Diameters 3.0mm, 3.5mm, 4.3mm, 5.0mm Lengths: 10- 15mm | Diameters 3.3mm, 4.1mm, 4.8mm Lengths 8mm, 10mm, 12mm, 14mm | Diameters 4.8mm, 6.5mm | Diameters 3.5mm, 4.0mm, 4.5 mm, 5.0mm Lengths 8mm, - 19mm, | | Type of Retention | Screw-retained to the implant. The prosthesis can be cement- retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement- retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the abutment. | | Manufacturing Process | Machining | Machining | Machining | Machining | Machining | Machining | Machining | | Abutment Sterilization | Moist Heat (Steam) | Moist Heat (Steam) | Moist Heat (Steam) | Moist Heat (Steam) | Moist Heat (Steam) | Moist Heat (Steam) | Moist Heat (Steam) | | Abutment Angulation | 0° - 30° | 0° - 30° | 0° - 30° | 0° - 30° | 0° - 25° | 0° - 20° | 0° - 20° |

ArgenIS Titanium Abutments

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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ArgenIS Titanium Abutments

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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