(280 days)
No
The summary describes a process of digitally designing and milling patient-specific dental abutments. While digital design is involved, there is no mention of AI or ML being used in the design process, analysis of patient data, or any other aspect of the device's function or manufacturing. The testing described is focused on mechanical properties and sterilization, not performance metrics typically associated with AI/ML.
Yes
The device is intended for the construction of dental restorations supported by endosseous dental implants, indicating it serves a therapeutic purpose by restoring dental function.
No
Explanation: The provided text describes the ArgenIS Titanium Abutments as components for dental restorations, specifically designed to support endosseous dental implants. Their function is to provide a connection point for prosthetic restorations, not to diagnose or detect medical conditions.
No
The device description clearly states that the device is a physical titanium abutment that is milled and supplied with screws. While digital design files are mentioned, the device itself is a physical component.
Based on the provided text, the ArgenIS Titanium Abutments are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the construction of dental restorations supported by endosseous dental implants. This is a structural and mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical component (an abutment) designed to connect a dental implant to a dental restoration. It is implanted into the patient's mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Anatomical Site: The device is used at the anatomical site of the endosseous dental implant, which is within the patient's mouth. IVDs typically interact with samples outside the body.
Therefore, the ArgenIS Titanium Abutments are a medical device, specifically a dental prosthetic component, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 Argents 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:
- Hiossen ET III SA, Platform 3.5mm, Manufacturer Hiossen, Implant Trade Name Hiossen Implant System, Implant Line/Connection Internal Hex, Implant Diameter 3.75, 3.77mm
- Hiossen ET III SA, Platform 4.0/4.5/5.0mm, Manufacturer Hiossen, Implant Trade Name Hiossen Implant System, Implant Line/Connection Internal Hex, Implant Diameter 4.25, 4.65, 4.63, 4.6, 5.1, 5.08, 5.05mm
- Nobel Active Wide Platform (WP), Platform 5.5mm, Manufacturer Nobel Biocare AB, Implant Trade Name Nobel Active Wide Platform (WP), Implant Line/Connection Internal Hex, Implant Diameter 5.5mm
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The ArgenIS 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. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used 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 endosseous implant body 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. There are no accessories associated with the subject devices.
Minimum and Maximum Gingival Height is 0.5mm - 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 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°
All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Test data was used to support substantial equivalency. Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks.
Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Worst case scenario was defined as the smallest diameter and shortest length from each platform. Performance testing demonstrated conformance to design input and indications for use.
The evaluation was based on FDA guidance "Class II Special Controls Guidance: Root -form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6.
The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices. Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices.
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.
ArgenIS Titanium Abutments - K160248
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.
Hiossen Implant System - K140934, Nobel Biocare Nobel Active Wide Platform (WP) - K133731
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.)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 18, 2018
Argen Corporation c/o Gordon Craig Regulatory Consultant Sterngold Dental. LLC 23 Frank Mossberg Drive Attleboro, Massachusetts 02703
Re: K172430
Trade/Device Name: ArgenIS Titanium Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 9, 2018 Received: April 16, 2018
Dear Gordon Craig:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172430
Device Name
ArgenIS Titanium Abutments
Indications for Use (Describe)
ArgentS 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 Argents 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 |
|------------------------------------|---------------|------------------|------------------------------------|----------------------------|------------------------------------------------|
| Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm |
| Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,
4.6, 5.1, 5.08,
5.05mm |
| Nobel Active Wide
Platform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active Wide
Platform (WP) | Internal Hex | 5.5mm |
Type of Use (Select one or both, as applicable)
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
-
- Sponsor: The Argen Corporation 5855 Oberlin Drive San Diego, CA 92121
-
- Contact: Paul Cascone Senior Vice-President of Research & Development Phone: 858-455-7900
-
- Date: May 18, 2018
- Trade Name: ArgenIS Titanium Abutments 4.
-
- 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 Device:
ArgenIS Titanium Abutments - K160248
Reference Devices:
Hiossen Implant System - K140934 Nobel Biocare Nobel Active Wide Platform (WP) - K133731
10. Description of Device:
The ArgenIS 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. The titanium abutment may be designed with a maximum angulation of 30°. The abutment is then fixed with the use of a lab screw to a model containing the implant analog for final construction of the related prosthetic restoration. The ArgenIS Titanium Abutments are then intended to be fixed in the mouth with the prosthetic final screw. The ArgenIS Titanium Abutments are supplied with two package configurations. One includes two final screws and the abutment and another includes one final screw and one lab screw and the abutment. The final screw is used for fixing abutment to the endosseous implant body, and the lab screw is used 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 endosseous implant body with the specific torque setting provided. The device is finalized at the Argen facility and
4
provided to the dental laboratory in a final patient specific form. There are no accessories associated with the subject devices.
Minimum and Maximum Gingival Height is 0.5mm - 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 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°
All digitally designed abutment files are intended to be sent to Argen manufacturer for milling. Argen is a registered contract manufacturer with a quality system under FDA QSR regulation.
11. 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 |
|------------------------------------|---------------|------------------|------------------------------------|----------------------------|------------------------------------------------|
| Hiossen ET III SA | 3.5mm | Hiossen | Hiossen Implant System | Internal Hex | 3.75, 3.77mm |
| Hiossen ET III SA | 4.0/4.5/5.0mm | Hiossen | Hiossen Implant System | Internal Hex | 4.25, 4.65, 4.63,
4.6, 5.1, 5.08,
5.05mm |
| Nobel Active Wide
Platform (WP) | 5.5mm | Nobel Biocare AB | Nobel Active Wide
Platform (WP) | Internal Hex | 5.5mm |
12. Technological Characteristics
The Argen IS Titanium Abutments are substantially equivalent to the currently marketed predicate devices. The intended use, fundamental operating principles, materials, technology and processes are the same as other Argen 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. The Indications for Use for the subject device differs from the primary predicate by the list of compatible implant bodies. Implant body compatibility and substantial equivalency was determined by comparing the design features including diameters, lengths, materials, implant-to-abutment connection platform and
5
intended use of proposed devices to predicate devices. Abutment design parameters are similar to the predicate devices and substantial equivalence has been demonstrated through performance testing data. 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 | Reference Device | Reference Device |
|---|---|---|---|---|
| ArgenIS Titanium | ||||
| Abutments | ||||
| The Argen Corporation | Argen IS Titanium | |||
| Abutments | ||||
| K160248 | ||||
| The Argen Corporation | Hiossen Implant System | |||
| K140934 | ||||
| Hiossen, Inc. | Nobel Biocare Nobel | |||
| Active Wide Platform | ||||
| (WP) | ||||
| K133731 | ||||
| NobelBiocare AB | ||||
| Material | Titanium-6AL-4 | |||
| Vanadium ELI Alloy | Titanium-6AL-4 | |||
| Vanadium ELI Alloy | CP Titanium | CP Titanium | ||
| Prosthetic | ||||
| Connection | Hiossen ET III SA | |||
| 3.5mm, 4.0/4.5/5.0mm | ||||
| Nobel Biocare 5.5mm | Nobel Biocare Replace | |||
| 6.0mm | ||||
| Nobel Biocare Active | ||||
| Straumann Bone Level, | ||||
| Straumann Synocta, | ||||
| Astra Tech OsseoSpeed | 3.5,3.77mm, 3.75mm, 4.2mm, | |||
| 4.25mm,4.45mm, 4.6mm, 4.63mm, | ||||
| 4.65mm,4.9mm,5.0mm,5.05mm,5.08mm, | ||||
| 5.1mm,5.92mm,5.95mm,6.0.6.8mm | Nobel Biocare Active | |||
| Wide Platform 5.5mm | ||||
| Indications for | ||||
| Use | 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 abutment files | ||||
| are intended to be sent to | ||||
| Argen manufacturer for | ||||
| milling. | 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 abutment files | ||||
| are intended to be sent to | ||||
| Argen manufacturer for | ||||
| milling. | Indicated for use in partially or fully | |||
| edentulous mandibles and maxillae in | ||||
| support of single or multiple unit | ||||
| restorations including cemented retained, | ||||
| screw retained or overdenture, and final | ||||
| or temporary abutment support for fixed | ||||
| bridgework. It is intended for delayed | ||||
| loading. ETIII SA Ultra Wide Fixture is | ||||
| intended to be used in the molar region. | 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. | ||||
| Nobel Biocare's | ||||
| NobelActive implants | ||||
| are indicated for single | ||||
| or multiple unit | ||||
| restorations in splinted | ||||
| or nonsplinted | ||||
| applications. Nobel | ||||
| Biocare's NobelActive | ||||
| implants are intended | ||||
| for immediate loading | ||||
| when good primary | ||||
| stability is achieved | ||||
| and with appropriate | ||||
| occlusal loading. | ||||
| Implant | ||||
| Diameters | Hiossen | |||
| 3.77, 3.75, 4.25, 4.65, | ||||
| 4.63, 4.6, 5.1, 5.08, | ||||
| 5.05mm | 3.3mm , 3.5mm, 4.0mm, | |||
| 4.1mm, 4.3mm, 4.5mm, | ||||
| 4.8mm, 6.0mm, 6.5mm | 3.5,3.77mm, 3.75mm, 4.25mm, 4.65mm, | |||
| 4.63mm, 4.6mm, 5.1mm, 5.08mm, | ||||
| 5.05mm | 5.5mm | |||
| Type of Retention | Nobel Biocare 5.5mm | |||
| 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 |
| Abutment | ||||
| Sterilization | Moist Heat (Steam) | Moist Heat (Steam) | Gamma Radiation | Gamma Radiation |
| Abutment | ||||
| Angulation | 30° | 30° | - | - |
14. Summary of Non-Clinical Performance Testing
Non-clinical Test data was used to support substantial equivalency. Non-Clinical testing consisted of reverse engineering of the OEM implant body, abutment and abutment screw
6
and tolerance analysis of platforms to ensure implant/abutment compatibility, dimensional verification and implant/abutment connection checks.
Fatigue testing was performed on worst case scenario samples in accordance with the Class II Special Controls Guidance Document and ISO 14801. Worst case scenario was defined as the smallest diameter and shortest length from each platform. Performance testing demonstrated conformance to design input and indications for use.
The evaluation was based on FDA guidance "Class II Special Controls Guidance: Root -form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
Moist Heat sterilization validation testing was performed in accordance with ANSI/AAMI/ISO 17665-1: 2006 and ISO ANSI/AAMI/ISO 17665-2: 2009. Test results demonstrate a sterility assurance level of 10-6.
The Argen IS Titanium Abutments have the same sterilization process and biocompatibility as previously cleared Argen and Sterngold devices.
Therefore sterility and bio-compatibility testing performed on cleared Argen devices is applicable to the proposed devices.
15. Conclusion
The proposed devices have similar technological characteristics, performance specifications and intended use as of its predicates.
Similar technological characteristics, performance testing data and intended use supports a determination of substantial equivalence of proposed devices to the predicate and reference devices.