(328 days)
Not Found
No
The document describes a patient-specific dental abutment that is milled from a titanium blank based on individual patient needs. There is no mention of AI, ML, or any computational methods used in the design or manufacturing process beyond standard CAD/CAM or milling techniques. The focus is on the physical characteristics and compatibility of the device.
No
The device is a dental abutment intended for the construction of dental restorations supported by endosseous dental implants, fitting individual patient needs to support tissue, esthetics, and function. It is a structural component of a dental prosthetic, not a therapeutic device designed to treat a disease or medical condition.
No.
The device is a patient-specific dental abutment used in the construction of dental restorations. It is a physical component of a dental implant system, designed to support a prosthetic restoration, not to diagnose a condition.
No
The device description clearly states that the device is a physical abutment milled from a titanium blank, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the construction of dental restorations supported by endosseous dental implants, specifically to support tissue, esthetics, and function. This is a structural and functional purpose within the body.
- Device Description: The device is a physical abutment milled from titanium, designed to be fixed to a dental implant in the mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to obtain information about a physiological state. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide diagnostic information.
- Anatomical Site: The device is used within the upper or lower jaw arches, which is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
The device is a medical device, specifically a dental implant abutment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 |
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
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.
| IMPLANT BRAND NAME | PLATFORM 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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of upper or lower jaw arches, maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals (dental technicians and Dentists)
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)
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.
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.
K062566, K130949, K081419, K133339, K083192, K130183, K132814
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.
Not Found
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/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.
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 (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
2
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)
3
510(k) Summary
| Sponsor: | The Argen Corporation
5855 Oberlin Drive
San Diego, CA 92121 | | | |
|---------------------------------------------------------|--------------------------------------------------------------------|--|--|--|
| Contact: | Maria Rao, Regulatory Consultant
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
4
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.
5
| IMPLANT BRAND NAME | PLATFORM
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:
6
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
Predicate | Predicate 2 | Predicate 3 | Predicate 4 | Predicate 5 | Predicate 6 and 7 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ArgenIS Titanium
Abutment Blanks
The Argen
Corporation | Nobel Replace
Tapered Conical
Connection
Nobel Biocare
K062566 | CP4 Osseotite
Certain Dental
Implants
Biomet 3i
K130949 | Straumann
Dental Implant
System
Straumann
K081419 | Zimmer Dental
Tapered
ScrewVent
Implants
Zimmer Dental
K133339 | Inclusive Titanium
Abutment Blanks
Inclusive Dental
K083192 | SFI Implant
Abutments
Sterngold Dental
K130183 K132814 |
| Material | Titanium-6AL-4
Vanadium ELI Alloy | Titanium-6AL-4
Vanadium ELI
Alloy | Titanium-6AL-4
Vanadium ELI
Alloy | Titanium-6AL-4
Vanadium ELI
Alloy | Titanium-6AL-4
Vanadium ELI
Alloy | Titanium-6AL-4
Vanadium ELI
Alloy | Titanium-6AL-4
Vanadium ELI
Alloy |
| Prosthetic
Connection | Nobel Biocare
Replace Select
Biomet 3i Certain
Straumann SynOcta
Zimmer TSV | Nobel Replace
Tapered Conical
Abutments | Biomet 3i Certain
Abutments | Straumann ITI
Abutments
Straumann
SynOcta | Zimmer
Tappered Screw-
Vent Abutments | Nobel Active
Internal NP and RP
Straumann Bone
Level NC and RC
Nobel Branemark
RP | Nobel Biocare
Branemark Nobel
Biocare Replace
Biomet 3i Certain
Biomet 3i Osseotite
Zimmer TSV
Straumann SLA
Active Astra
OsseoSpeed |
| Indications for Use | See Indications for
Use Statement above | Intended to be
surgically placed
in the bone of
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
surgical placement
in the upper or
lower jaw to
provide a means
for prosthetic
attachment in
single tooth
restorations and in
partially or fully
edentulous patients | 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. | Intended for use
in the maxilla or
mandible for
immediate
loading or for
loading after
conventional or
delayed healing
period. | Intended to be used
in conjunction with
endosseous implants
in the maxillary
and/or mandibular
arch to provide
support for crowns,
bridges or
overdenture
prostheses. | Intended to be used
with dental
implants to support
and/or retain
removable dental
prostheses for
partially or totally
edentulous patients
to restore chewing
function. |
| Platform
type/diameter,
abutment parameters | See Device
Description
above | Internal Hex;
3.5mm, 4.3, 5.0;
30° angulation | Internal Hex;
3.4mm, 4.1, 5.0;
30° angulation | Internal Hex;
4.8mm;
30° angulation | Internal Hex;
3.5mm, 4.5, 5.7;
30° angulation | Different
compatible
implant
platforms; 30°
angulation | No anti-rotation
design; multi-unit
systems only |
| 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. |
7
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.