(271 days)
Nil. Not in scope.
No
The summary describes a process involving CAD/CAM technology for milling patient-specific dental abutments. There is no mention of AI or ML being used in the design or manufacturing process. The "Not Found" entries for "Mentions AI, DNN, or ML", "Description of the training set", and "Description of the test set" further support this conclusion.
No.
The device is a pre-milled abutment intended to provide support for prosthetic restorations like crowns or bridges, which are supportive components, not therapeutic in nature.
No
The device, HIOSSEN Pre-milled Abutments, is a prosthetic component designed to support dental restorations. Its function is mechanical support, not the detection, diagnosis, or monitoring of medical conditions.
No
The device is a physical medical device (dental abutment) that is manufactured using CAD/CAM technology. While software is used in the design and milling process, the device itself is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The HIOSSEN Pre-milled Abutments are physical components used in dental procedures to support prosthetic restorations. They are implanted into the patient's jawbone and do not involve testing biological samples.
- Intended Use: The intended use clearly states the device is for providing support for prosthetic restorations, not for diagnostic testing.
- Device Description: The description details the material, manufacturing process (milling), and how it's used in conjunction with dental implants and prosthetic restorations. There is no mention of analyzing biological samples.
Therefore, the HIOSSEN Pre-milled Abutments fall under the category of a medical device used for surgical and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures.
All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
ET HIOSSEN Pre-milled Abutments are compatible with the following devices:
- ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide Regular) - K140934 / Implant Diameter (mm):3.5, 3.75, 3.77, 4.2, 4.25, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8
- ETIII NH Dental Implants (Mini & Regular, Ultra-wide Regular) - K151626 /Implant Diameter (mm): 3.77, 3.75, 4.25, 4.6 4.65, 4.63, 5.05, 5.08, 5.10
- ETIII SA D3.2 Dental Implants (Mini) - K153332 /Implant Diameter (mm): 3.2
- ET IV SA Dental Implants (Regular & Ultra-wide)- K183242 /Implant Diameter (mm):4.4, 4.8, 5.25, 6.2 & 7.1
EK HIOSSEN Pre-milled Abutments are compatible with the following devices:
- EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360 /Implant Diameter (mm):3.5~5.5
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
HIOSSEN Pre-milled Abutments are intended to support prosthetic restorations such as crowns, bridges or overdentures and used only with the Hiossen implant fixtures. HIOSSEN Pre-milled Abutments are customized (Milled) as per the patient specific requirements in the Hiossen validated milling laboratory. The HIOSSEN Pre-milled Abutments are designed and manufactured by Hiossen, Inc.
HIOSSEN Pre-milled Abutment system:
ET HIOSSEN Pre-milled Abutments: The Hiossen Pre-milled Abutments are straight titanium abutments intended to support the prosthetic restorations such as crowns, bridges or overdentures and intended to connect to the Hiossen implant system, ETIII Nano-NH Fixture System, ETIII SA Fixture system, and ET IV SA Dental Implant System.
EK HIOSSEN Pre-milled Abutments: The Hiossen Pre-milled Abutments are straight titanium abutments intended to support the prosthetic restorations such as crowns, bridges or overdentures and intended to connect to the EKIII SA Dental Implants and EKIII NH Dental Implants.
The HIOSSEN Pre-milled Abutments are Ti-6Al-4V titanium alloy (ASTM F136) cylindrical "blanks" with HIOSSEN dental implant-specific interface (abutment to implant connection and screw channel) to be designed and milled at a HIOSSEN validated milling facility using CAD/CAM technology to fabricate a patient-specific abutment.
The blank cylindrical HIOSSEN Pre-milled Abutments are supplied to the Hiossen validated milling centre. Based on the design requirements provided by the dentist, the lab will design abutment using 510k cleared CAD software and blank cylinders will be milled using the CAM machine. This customized patient specific milled abutment will be sent back to the dentist for implantation into the patient after steam sterilization.
The blank cylindrical HIOSSEN Pre-milled Abutments are available with connections where one end is connected to CAM machine and the other end is connected to the Implant fixtures as described in Figure 1. Only milling range marked in Figure 1 will be milled using the CAM Abutments according to the specification.
The blank cylindrical HIOSSEN Pre-milled Abutments are designed to connect to the respective implant fixture system with hex and non-hex connection types. They are available in two connection sizes: Mini and Regular. The Mini connection size fits HIOSSEN fixtures with diameters of 3.5 or less (3.2 & 3.5), while the Reqular connection size fits HIOSSEN fixtures with diameters of 4.0 or greater (4.0, 4.5, 5.0, 6.0, & 7.0).
ET HIOSSEN Pre-milled Abutments are designed to connect to HIOSSEN Implant System diameters (3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm), ETIII Nano-NH Fixture System diameters (3.5. 4.0. 4.5. 5.0. 6.0. 7.0 mm), ETIII SA Fixture System (D3.2) diameters (3.2 mm) and ET IV SA Dental Implants diameters (4.0, 4.5, 5.0, 6.0, 7.0 mm).
EK HIOSSEN Pre-milled Abutments are designed to connect to Hiossen EKIII SA Dental Implants system diameter (3.5, 4.0, 4.5, 5.0, 5.5) and EKIII NH Dental Implant system diameter (3.5, 4.0, 4.5, 5.0, 5.5).
HIOSSEN Pre-milled Abutments are screw-retained straight Abutments. The ET EbonyGold Screw, ET Ti Abutment Screw, and EK Ti Abutment Screw is used to retain the Abutment with the implant fixtures. The Ebony Gold Screw is made up of Titanium Alloy (ASTM F 67) which 510k cleared under K123627. EK Ti Screw is also 510k cleared under K203360.
Specifications:
Parameters: Material, Specification: Titanium alloy Ti-6AI-4V (ASTM F 136)
Parameters: Surface, Specification: Machined finished
Parameters: Implant abutment connection, Specification: Conical
Parameters: Connection size, Specification: Mini, Regular
Parameters: Connection type, Specification: Hex, non-hex
Abutment design parameters:
Minimum wall thickness: 0.7mm
Minimum gingival height: 0.5mm
Minimum post height (length above the abutment collar / gingival height): 4.0mm
Maximum post height (length above the abutment collar / gingival height): 17.5mm
Angulation: 0°
Maximum diameter: 6.8mm
CAD Software: 510(k) cleared only
Compatibility: HIOSSEN dental implants
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 worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795). Rationale addressed parameters per the FDA guidance "Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices.
The available non-clinical data are sufficient to support the safety and performance of HIOSSEN Pre-milled Abutments. Hence clinical studies are not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221972, K140934, K151626, K153332, K183242, K203360
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
January 8, 2025
Hiossen, Inc. % Ankur Naik Managing Director IZiel Healthcare Pentagon P1, Office No. 601 and 604 Magarpatta City, Hadapsar Pune, Maharashtra 411028 INDIA
Re: K241003
Trade/Device Name: HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 9, 2024 Received: December 9, 2024
Dear Ankur Naik:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241003
Device Name
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
Indications for Use (Describe)
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures.
All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
ET HIOSSEN Pre-milled Abutments are compatible with the following devices: 1. ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide Regular) - K140934 / Implant Diameter (mm):3.5, 3.75, 3.77, 4.2, 4.25, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8 2. ETIII NH Dental Implants (Mini & Regular, Ultra-wide Regular) - K151626 /Implant Diameter (mm): 3.77, 3.75, 4.25, 4.6 4.65, 4.63, 5.05, 5.08, 5.10 3. ETIII SA D3.2 Dental Implants (Mini) - K153332 /Implant Diameter (mm): 3.2 4. ET IV SA Dental Implants (Regular & Ultra-wide)- K183242 /Implant Diameter (mm):4.4, 4.8, 5.25, 6.2 & 7.1
EK HIOSSEN Pre-milled Abutments are compatible with the following devices:
| 1. EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360 |
|---|
| /Implant Diameter (mm):3.5~5.5 |
| 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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4
K241003 - 510(k) Summary
| Date: | 08 January 2025 |
|---|---|
| Submitter (Owner): | Peter Lee |
| QA/RA Manager | |
| Hiossen, Inc. | |
| 85 Ben Fairless Drive, | |
| Fairless Hills, PA 19030. | |
| P: 888-768-0001 | |
| Email: peter.l@hiossen.com | |
| 510(k) Contact Person: | Ankur Naik |
| Managing Director | |
| IZiel Healthcare | |
| Pentagon P1, Office No. 601 & 604, Magarpatta City, | |
| Hadapsar, Pune 411028. | |
| P: +91 72762 2555 M: +91 7069553814 | |
| Email: ankur.naik@izielhealthcare.com | |
| Device Trade Name: | HIOSSEN Pre-milled Abutment (ET Pre-milled |
| Abutment & EK Pre-milled Abutment) | |
| Regulation Number: | 21 CFR 872.3630 |
| Review Panel: | Dental |
| Device Class: | Class II |
| Product Code: | NHA |
| Predicate Device: | ET SMARTFit Abutment (K123627) |
| Reference Device: | Warantec Custom Abutment (K221972) |
| HIOSSEN Implant System (K140934) | |
| ETIII Bio-SA Fixture System (K151626) | |
| ETIII SA Fixture System (Ø 3.2mm) (K153332) | |
| ET IV SA Dental Implants (K183242) | |
| EK Dental Implants and Abutments (K203360) |
Device Description
HIOSSEN Pre-milled Abutments are intended to support prosthetic restorations such as crowns, bridges or overdentures and used only with the Hiossen implant fixtures. HIOSSEN Pre-milled Abutments are customized (Milled) as per the patient specific requirements in the Hiossen validated milling laboratory. The HIOSSEN Pre-milled Abutments are designed and manufactured by Hiossen, Inc.
5
| Model No | Model Name | Model Description |
|---|---|---|
| HIOSSEN Pre- | ||
| milled Abutment | ||
| system | ET HIOSSEN | |
| Pre-milled | ||
| Abutments | The Hiossen Pre-milled Abutments are | |
| straight titanium abutments intended to | ||
| support the prosthetic restorations such as | ||
| crowns, bridges or overdentures and | ||
| intended to connect to the Hiossen implant | ||
| system, ETIII Nano-NH Fixture System, | ||
| ETIII SA Fixture system, and ET IV SA | ||
| Dental Implant System. | ||
| EK HIOSSEN | ||
| Pre-milled | ||
| Abutments | The Hiossen Pre-milled Abutments are | |
| straight titanium abutments intended to | ||
| support the prosthetic restorations such as | ||
| crowns, bridges or overdentures and | ||
| intended to connect to the EKIII SA Dental | ||
| Implants and EKIII NH Dental Implants. |
The HIOSSEN Pre-milled Abutments are Ti-6Al-4V titanium alloy (ASTM F136) cylindrical "blanks" with HIOSSEN dental implant-specific interface (abutment to implant connection and screw channel) to be designed and milled at a HIOSSEN validated milling facility using CAD/CAM technology to fabricate a patient-specific abutment.
The blank cylindrical HIOSSEN Pre-milled Abutments are supplied to the Hiossen validated milling centre. Based on the design requirements provided by the dentist, the lab will design abutment using 510k cleared CAD software and blank cylinders will be milled using the CAM machine. This customized patient specific milled abutment will be sent back to the dentist for implantation into the patient after steam sterilization.
The blank cylindrical HIOSSEN Pre-milled Abutments are available with connections where one end is connected to CAM machine and the other end is connected to the Implant fixtures as described in Figure 1. Only milling range marked in Figure 1 will be milled using the CAM Abutments according to the specification.
6
Image /page/6/Figure/0 description: The image shows two dental milling tools with labels indicating their features. The tool on the left has a label indicating the 'Milling Range'. The tool on the right has two labels, one pointing to the top indicating 'CAM connection' and another pointing to the bottom indicating 'HIOSSEN implant connection'. Both tools appear to be made of metal and have a cylindrical shape.
Figure 1: Illustration and Specifications
The blank cylindrical HIOSSEN Pre-milled Abutments are designed to connect to the respective implant fixture system with hex and non-hex connection types. They are available in two connection sizes: Mini and Regular. The Mini connection size fits HIOSSEN fixtures with diameters of 3.5 or less (3.2 & 3.5), while the Reqular connection size fits HIOSSEN fixtures with diameters of 4.0 or greater (4.0, 4.5, 5.0, 6.0, & 7.0).
ET HIOSSEN Pre-milled Abutments are designed to connect to HIOSSEN Implant System diameters (3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm), ETIII Nano-NH Fixture System diameters (3.5. 4.0. 4.5. 5.0. 6.0. 7.0 mm), ETIII SA Fixture System (D3.2) diameters (3.2 mm) and ET IV SA Dental Implants diameters (4.0, 4.5, 5.0, 6.0, 7.0 mm).
EK HIOSSEN Pre-milled Abutments are designed to connect to Hiossen EKIII SA Dental Implants system diameter (3.5, 4.0, 4.5, 5.0, 5.5) and EKIII NH Dental Implant system diameter (3.5, 4.0, 4.5, 5.0, 5.5).
HIOSSEN Pre-milled Abutments are screw-retained straight Abutments. The ET EbonyGold Screw, ET Ti Abutment Screw, and EK Ti Abutment Screw is used to retain the Abutment with the implant fixtures. The Ebony Gold Screw is made up of Titanium Alloy (ASTM F 67) which 510k cleared under K123627. EK Ti Screw is also 510k cleared under K203360.
| Parameters | Specification |
|---|---|
| Material | Titanium alloy Ti-6AI-4V (ASTM F 136) |
| Surface | Machined finished |
| Implant abutment connection | Conical |
| Connection size | Mini, Regular |
| Connection type | Hex, non-hex |
Specification:
7
| Parameters | Specification |
|---|---|
| Abutment design parameters | Minimum wall thickness: 0.7mm |
| Minimum gingival height: 0.5mm | |
| Minimum post height (length above the | |
| abutment collar / gingival height): 4.0mm | |
| Maximum post height (length above the | |
| abutment collar / gingival height): 17.5mm | |
| Angulation: 0° | |
| Maximum diameter: 6.8mm | |
| CAD Software | 510(k) cleared only |
| Compatibility | HIOSSEN dental implants |
Intended Use / Indications for Use
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility.
ET HIOSSEN Pre-milled Abutments are compatible with the following devices:
-
ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide Regular) - K140934 / Implant Diameter (mm):3.5, 3.75, 3.77, 4.2, 4.25, 4.45, 4.6, 4.25, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8
-
ETIII NH Dental Implants (Mini & Regular, Ultra-wide Regular) - K151626 /Implant Diameter (mm): 3.77, 3.75, 4.25, 4.6 4.65, 4.63, 5.05, 5.08, 5.10 3. ETIII SA D3.2 Dental Implants (Mini) - K153332 /Implant Diameter (mm): 3.2
-
ET IV SA Dental Implants (Regular & Ultra-wide)- K183242
/Implant Diameter (mm):4.4, 4.8, 5.25, 6.2 & 7.1
EK HIOSSEN Pre-milled Abutments are compatible with the following devices: 1. EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360 /Implant Diameter (mm):3.5 ~ 5.5
8
Substantial Equivalence Discussion
The ET SMARTFit Abutment (K123627) has been selected as the primary predicate device. Additional devices have been selected as reference devices to demonstrate the compatibility of the HIOSSEN Pre-milled Abutments with dental implant systems and include:
-
- Warantec Custom Abutment K221972
-
- HIOSSEN Implant System K140934
-
- ETIII Bio-SA Fixture System K151626
-
- ETIII SA Fixture System (Ø 3.2mm) K153332
-
- ET IV SA Dental Implants K183242
-
- EK Dental Implants and Abutments K203360
The HIOSSEN Pre-milled Abutments are milled at a "validated milling center," as specified in the indications for use. The reference device, the Warantec Custom Abutment, has been selected to support this indication.
The HIOSSEN Pre-milled Abutments are compatible with dental implant systems which are 510(k) cleared through 510(k) numbers K140934, K151626, K153332, K183242 & K203360 and are considered reference devices.
Details regarding the substantial equivalence between the subject device, the predicate device, and the reference devices are explained below.
9
Technological Characteristics Comparison
| Device | Subject Device | Primary Predicate Device - K123627 | Reference Device – K221972 | Comparison results |
|---|---|---|---|---|
| Product name | HIOSSEN Pre-milled Abutments | ET SMARTFit Abutment | Warantec Custom Abutment | Not applicable |
| Manufacturer | Hiossen, Inc. | Hiossen, Inc. | Warantec Co., Ltd. | Not applicable |
| Classification name | Abutment, Implant, Dental, Endosseous | Abutment, Implant, Dental, Endosseous | Abutment, Implant, Dental, Endosseous | Identical |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Product Code | NHA | NHA | NHA | Identical |
| Product class | Class II | Class II | Class II | Identical |
| Indications for use | The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility. | ET SMARTFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures | The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. | |
| All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec validated milling center for manufacture. | Similar | |||
| The HIOSSEN Pre-milled Abutments also include the compatible devices and their corresponding 510(k) numbers additionally. | ||||
| Device | Subject Device | Primary Predicate | ||
| Device - K123627 | Reference Device - | |||
| K221972 | Comparison results | |||
| ET HIOSSEN Pre- | ||||
| milled Abutments are | ||||
| compatible with the | ||||
| following devices: |
- ETIII & ETII SA
Dental Implants (Mini,
Regular, (Ultra-wide
Regular) - K140934 | | | |
| | / Implant Diameter
(mm):3.5, 3.75, 3.77,
4.2, 4.25, 4.45, 4.6,
4.25, 4.63, 4.65, 4.9,
5.0, 5.05, 5.08, 5.1,
5.92, 5.95, 6, 6.8 | | | |
| | 2. ETIII NH Dental
Implants (Mini &
Regular, Ultra-wide
Regular) - K151626 | | | |
| | /Implant Diameter (mm):
3.77, 3.75, 4.25, 4.6
4.65, 4.63, 5.05, 5.08,
5.10 | | | |
| | 3. ETIII SA D3.2 Dental
Implants (Mini) -
K153332 | | | |
| | /Implant Diameter (mm):
3.2 | | | |
| | 4. ET IV SA Dental
lmplants (Regular &
Ultra-wide)- K183242 | | | |
| Device | Subject Device | Primary Predicate Device - K123627 | Reference Device – K221972 | Comparison results |
| | /Implant Diameter
(mm):4.4, 4.8, 5.25, 6.2 & 7.1
EK HIOSSEN Pre-milled Abutments are compatible with the following devices:
- EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360
/Implant Diameter (mm):3.5 ~ 5.5 | | | |
| Image | Image: Two cylindrical objects, one slightly larger than the other, both silver with a black circle on the side. | Image: Three abutments, two silver and one gold. | - | Similar |
| Material | Titanium alloy Ti-6Al-4V (ASTM F 136) | Titanium alloy Ti-6Al-4V (ASTM F 136) | Ti-6Al-4V ELI (ASTM F136) | Identical to predicate device. |
| Surface | Machined finished | Machined finished | - | Identical |
| Connection | Conical | Conical | - | Identical |
| Abutment design parameters | Minimum wall thickness: 0.7mm | Minimum wall thickness: 0.7mm | Minimum thickness: 0.4 mm | The HIOSSEN Pre-milled Abutments are straight, whereas the |
| Device | Subject Device | Primary Predicate
Device - K123627 | Reference Device -
K221972 | Comparison results |
| | Minimum gingival
height: 0.5mm
Minimum post height
(length above the
abutment collar /
gingival height): 4.0m
Maximum post height
(length above the
abutment collar /
gingival height):
17.5mm
Angulation: 0°
Maximum diameter:
6.8mm | Minimum gingival
height: 0.5mm
Minimum post height:
4.0m
Maximum post height:
17.5mm
Maximum angulation:
30°
Maximum diameter:
6.8mm | Minimum gingival
height: 0.5mm
Minimum post height:
4.0mm
Maximum post height:
8 mm
Maximum angulation:
30°
Maximum diameter:
6.0mm | predicate devices are
both straight and
angled abutments. |
| Sterility | Provided non-sterile,
end-user sterilization | Provided non-sterile,
end-user sterilization | Provided non-sterile,
end-user sterilization | Identical |
| Sterilization | Moist Heat | Moist Heat | Autoclave | Identical |
| CAD
Software | 510(k) cleared only | - | 510(k) cleared only | Identical |
| Surface
Treatment | None | None | None | Identical |
| Compatible
Implants | ET HIOSSEN Pre-
milled Abutments are
compatible with the
following device:
• ETIII & ETII SA
Dental Implants
(Mini, Regular,
(Ultra-wide Regular)
- K140934
• ETIII NH Dental
Implants (Mini & | ET SMARTFit
Abutment is
compatible with the
following device:
• ETIII SA Dental
Implants (Mini,
Regular, (Ultra-
wide Regular) -
K140934
• ETIII NH Dental
Implants (Mini & | Not available | The HIOSSEN Pre-
milled Abutments are
compatible with the
following 510(k)-
cleared dental implant
systems:
- • HIOSSEN Implant
System - K140934 - • ETIII Bio-SA Fixture
System - K151626 |
| Device | Subject Device | Primary Predicate Device - K123627 | Reference Device – K221972 | Comparison results |
| | Regular, Ultra-wide Regular) - K151626 ETIII SA D3.2 Dental Implants (Mini) - K153332 ET IV SA Dental Implants (Regular & Ultra-wide)- K183242 EK HIOSSEN Pre-milled Abutments are compatible with the following device: EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360 | Regular, Ultra-wide Regular) - K151626 ETIII SA D3.2 Dental Implants (Mini) - K153332 ET IV SA Dental Implants (Regular & Ultra-wide)- K183242 | | 3. ETIII SA Fixture System (Ø 3.2mm) - K153332 - ET IV SA Dental Implants - K183242
- EK Dental Implants and Abutments - K203360
This does not raise any concern regarding the safety or performance of the device. |
| Compatible screw | ET HIOSSEN Pre-milled Abutments will be implanted either with the ET Ebony Gold Screw (K123627) or the ET Ti Screw (K123627).
EK HIOSSEN Pre-milled Abutments will be implanted with the Ti Abutment Screw (K203360) | ET SMARTFit Abutment will be implanted either with the ET Ebony Gold Screw (K123627) or the ET Ti Screw (K123627). | Not available | Similar
The subject device is intended to be used with screw that are already 510(k)-cleared. Therefore, this does not raise any concern regarding the safety or performance of the device. |
Table 1: Technological Characteristics Comparison
10
11
12
13
14
Discussion of similarities and differences:
The HIOSSEN Pre-milled Abutments (including the ET Premilled Abutments and EK Premilled Abutments) are similar to the predicate device, with the only noted difference being that the HIOSSEN Pre-milled Abutments are milled at a Hiossenvalidated milling facility, whereas the ET Smartfit Abutments are manufactured at the Hiossen site. However, the Hiossen-validated milling facility operates identically to the reference device's manufacturing process. Both devices use CAD/CAM technology to mill the abutments based on the technical specifications provided by the dentist. Furthermore, the Hiossen-validated milling facilities adhere to HIOSSEN's strict and stringent Quality Management System (QMS) policies. HIOSSEN performs periodic audits of these facilities and requires records of product inspections. Therefore, this difference does not raise any concern regarding the safety or performance of the device. The HIOSSEN Pre-milled Abutments are made of Titanium alloy Ti-6AI-4V (ASTM F 136), which is identical to the material used in both the predicate and reference devices. The HIOSSEN Pre-milled Abutments are compatible with 510(k)-cleared dental implant systems that are identical to the following reference devices: HIOSSEN Implant System - K140934, ETIII Bio-SA Fixture System - K151626, ETIII SA Fixture System (Ø 3.2mm) - K153332, ET IV SA Dental Implants - K183242 & EK Dental Implants and Abutments - K203360.
Performance data
The HIOSSEN Pre-milled Abutments comply with the requirements of the special control documents "Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and the products have been developed as per 21 CFR 820 and have completed design control activities, including risk management, verification, and validation.
The HIOSSEN Pre-milled Abutments complies with the following standards:
Labels & IFU:
-
- ISO 15223-1 Fourth edition 2021-07 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
-
- ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -Information to be supplied by the manufacturer.
Biocompatibility:
-
- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
15
Biocompatibility testing is being leveraged from the primary predicate device -K123627 where the device was evaluated as per the above-mentioned standard.
Sterilization:
-
- ISO 17665-1 First edition 2006-08-15 Sterilization of health care products Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
-
- ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products -Moist heat - Part 2: Guidance on the application of ISO 17665-1.
-
- ANSI/AAMI ST79:2010, A1:2010 and A2:2011 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Sterilization validation for the primary predicate device was conducted in accordance with the aforementioned standards. Since there is no difference in the sterilization method or its parameters between the subject device and the primary predicate device, the sterilization validation data from the primary predicate device is being leveraged for the subject device.
MR safety environment:
Non-clinical worst-case MRI review was performed to evaluate the subject devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 4 9.2 (2 01 9): 7 8 3-795). Rationale addressed parameters per the FDA guidance "Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The non-clinical testing results demonstrate that the subject devices are substantially equivalent to the predicate devices
Summary of Clinical Testing:
The available non-clinical data are sufficient to support the safety and performance of HIOSSEN Pre-milled Abutments. Hence clinical studies are not required.
Conclusion
All the above details collectively demonstrate that HIOSSEN Pre-milled Abutments are safe and effective when the device is used as labelled and are substantially equivalent to the predicate device.