(193 days)
No
The summary describes a dental implant made of titanium alloy with a specific surface treatment. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on material properties and physical performance, not algorithmic performance.
No
The device is a dental implant system designed to support prosthetic devices and restore chewing function. While it aids in a patient's health by restoring function, it does not fit the typical definition of a "therapeutic device" which usually implies a direct treatment or intervention for a disease or condition, rather than a supportive functional replacement.
No
The device, the EM SA Implant System, is a dental implant intended for supportive rather than diagnostic purposes. Its function is to support dental prosthetic devices to restore chewing function, not to diagnose a condition.
No
The device description explicitly states it is a dental implant made of titanium alloy and is surgically placed, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the EM SA Implant System is a dental implant made of titanium alloy intended to be surgically placed in the bone of the jaw.
- Intended Use: The intended use is to provide support for dental prosthetic devices to restore chewing function. This is a surgical and mechanical function within the body.
The device is a surgically implanted medical device, not a device used for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.
The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.
The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).
| Device | Thread Diameter(mm) | Thread Length(mm) |
|---|---|---|
| EM SA Implant System (Denture) | Ø2.0, Ø2.5, Ø3.0 | 8.5, 10.0, 11.5, 13.0, 15.0 |
| EM SA Implant System (Narrow Ridge) | Ø2.5, Ø3.0 | 8.5, 10.0, 11.5, 13.0, 15.0 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches, mandibular central and lateral incisors
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 Performance Data
Biocompatibility Testing: The EM SA Implant System is manufactured using the same manufacturing process and same well known and well established material as the primary predicate device, the MS SA Implant System, K122171, therefore it was not necessary to re-test biocompatibility.
Sterilization Validation: The EM SA Implant System (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the primary predicate device, the MS SA Implant System, K122171 and validated following ISO 11137 [2006] Sterilization of health care products - Requirements for Validation and Routine control - Radiation Sterilization guidelines, therefore it was not necessary to re-test validation.
Shelf Life: The EM SA shelf life is identical to the reference device HIOSSEN Implant System which has been validated for eight (8) years following ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. No shelf-life validation or accelerated aging testing was performed.
Surface Treatment Characterization Testing: The EM SM Implant System is manufactured using the same manufacturing process, material and well known and well established surface treatment, SA (Sand blasted, Acid etched) as the predicate device, the MS SA Implant system, K122171, therefore no additional character testing was necessary.
Fatigue Testing: The EM SA Implant System is manufactured using the same manufacturing process, material and very similar design, as the MS SA which was fatigue tested in accordance with ISO 14801:2003 Dentistry -Fatigue Test for Endosseous Dental Implants, therefore it was not necessary to re-test fatigue.
Clinical Performance Testing: No clinical performance report(s) is being submitted.
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.
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 15, 2019
Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K191201
Trade/Device Name: EM SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 14, 2019 Received: November 15, 2019
Dear Peter Lee:
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. 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 located 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
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
for
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a sans-serif font, with the "H" in red and the rest of the letters in gray. A red swoosh appears above the "H". Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters.
85 Ben Fairless Drive airless Hills PA 19030 888-768-0001 www.hiossen.com
Section 5 Indication for Use Statement - 1 PAGE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191201 Device Name EM SA Implant System
Indications for Use (Describe)
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.
The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
Type of use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 807 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Service (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------ |
3
Image /page/3/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products.
510(k) Summary
| (1) Submitter Information:
Submitted by: | Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills, PA 19030 |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Contact Person:
Telephone Number:
Fax Number: | Peter Lee
267-759-7031
267-759-7031 |
| Date Prepared: | November 15, 2019 |
| (2) Device Name:
• Proprietary Name:
• Classification Name:
• CFR Number:
• Device Class:
• Product Code: | EM SA Implant System
Endosseous dental implant
872.3640
Class II
DZE |
(3) Predicate Devices:
| Device | 510(k) | Manufacturer | |
|---|---|---|---|
| Primary Predicate | MS SA Implant System | K122171 | OSSTEM |
| Reference Device | MS System | K083067/ | |
| K072959 | OSSTEM | ||
| Reference Device | Hiossen Implant System | K140934 | HIOSSEN |
(4) Description of Device:
The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.
The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).
| Device | Thread Diameter(mm) | Thread Length(mm) |
|---|---|---|
| EM SA Implant System (Denture) | Ø2.0, Ø2.5, Ø3.0 | 8.5, 10.0, 11.5, 13.0, 15.0 |
| EM SA Implant System (Narrow Ridge) | Ø2.5, Ø3.0 | 8.5, 10.0, 11.5, 13.0, 15.0 |
(5) Indication For Use:
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.
The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading. EM SA IMPLANT SYSTEM TRADITIONAL 510(k) Confidential
4
Image /page/4/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com
(6) Substantial Equivalence:
HIOSSEN believes the EM SA Implant System is substantially equivalent to the primary predicate device, OSSTEM MS SA Implant System in November 2012 (510(k) number K122171).
| Proposed Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Device | EM SA Implant | MS SA System | MS System | HIOSSEN IMPLANT |
| System (Denture) | (Denture) | SYSTEM | ||
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | Osstem Co., Ltd. | Hiossen, Inc. |
| 510(K) No. | New device | K122171 | K083067/K072959 | K140934 |
| Design | ||||
| Intended use | The EM SA Implant | |||
| System (DENTURE) | ||||
| is intended to be | ||||
| place in the bone of | ||||
| the upper or lower | ||||
| jaw arches providing | ||||
| support to dental | ||||
| prosthetic devices, | ||||
| more specifically | ||||
| denture stabilization | ||||
| to restore a patient's | ||||
| chewing function. It is | ||||
| intended for single | ||||
| use only. | The MS System | |||
| (Denture) is intended | ||||
| to be place in the | ||||
| bone of the upper or | ||||
| lower jaw arches to | ||||
| provide support the | ||||
| prosthetic devices to | ||||
| restore the patient's | ||||
| chewing function, | ||||
| including the denture | ||||
| stabilization. The MS | ||||
| System (Denture) is | ||||
| intended for single | ||||
| use only. | The MS System | |||
| (Denture) is intended | ||||
| to be place in the | ||||
| bone of the upper or | ||||
| lower jaw arches to | ||||
| provide support the | ||||
| prosthetic devices to | ||||
| restore the patient's | ||||
| chewing function, | ||||
| including the denture | ||||
| stabilization. The MS | ||||
| System (Denture) is | ||||
| intended for single | ||||
| use only. | The HIOSSEN | |||
| Implant System is | ||||
| 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 | ||||
| restorations, and final | ||||
| or temporary | ||||
| abutment support for | ||||
| fixed bridgework. It is | ||||
| intended for delayed | ||||
| loading. Ultra wide | ||||
| Fixture System is | ||||
| intended to be used | ||||
| in the molar region. | ||||
| Structure | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2/4mm gingival | ||||
| height neck | ||||
| • Ball-shaped head | ||||
| for O-Ring | ||||
| attachment. | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2/4mm gingival | ||||
| height neck | ||||
| • Ball-shaped head | ||||
| for O-Ring | ||||
| attachment. | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2/4mm gingival | ||||
| height neck | ||||
| • Ball-shaped head | ||||
| for O-Ring | ||||
| attachment. | • Internal Hex- | |||
| connected | ||||
| • Submerged Fixture | ||||
| • Tapered body | ||||
| shape & Straight | ||||
| body shape | ||||
| Thread | 2.0, 2.5, 3.0 | 2.5, 3.0 | 2.0 ~ 3.0 | 3.5~6.8 |
| Diameters | ||||
| Thread | ||||
| Lengths | 8.5, 10.0, 11.5, 13.0, | |||
| 15.0 | 10.0, 13.0, 15.0 | 8.5, 10.0, 13.0, 15.0 | 6.2~18.2 | |
| Material | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Pure Titanium Grade | |||
| 4 (ASTM F67) | ||||
| Surface | SA (Sandblasted and | |||
| Acid etched). | - SA(Sandblasted | |||
| and Acid etched) | RBM (Resorbable | |||
| Blast Media) | - SA(Sandblasted | |||
| and Acid etched) | ||||
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Packaging | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| tamper-evident outer | ||||
| package. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a outer | ||||
| box. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a outer | ||||
| box. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| tamper-evident outer | ||||
| package. | ||||
| S.E. | The proposed device is substantially equivalent with respect to the intended use, structure, | |||
| material, surface, sterilization and design with the legally marketed primary predicate device as | ||||
| well as the surface, sterilization and packaging of the legally marketed reference device. The | ||||
| slight difference in thread diameter and length is a simple size addition. The proposed device | ||||
| does not pose any new or increased risks as compared to the legally marketed primary | ||||
| predicate and reference devices. |
5
Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in gray below "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products.
| Device | Proposed Device
EM SA Implant
System
(Narrow Ridge) | Primary Predicate
MS SA Implant
System
(Narrow Ridge) | Reference Device
MS System | Reference Device
HIOSSEN IMPLANT
SYSTEM |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | Osstem Co., Ltd. | Hiossen, Inc. |
| 510(K) No. | New device | K122171 | K083067 | K140934 |
| Design | Image: Proposed Device EM SA Implant System (Narrow Ridge) | Image: Primary Predicate MS SA Implant System (Narrow Ridge) | Image: Reference Device MS System | Image: Reference Device HIOSSEN IMPLANT SYSTEM |
| Intended use | The EM SA Implant
System (NARROW
RIDGE) is intended
to be use in the
treatment of missing
mandibular central
and lateral incisors to
support dental
prosthetic devices,
such as artificial
teeth, in order to
restore chewing
function in partially
edentulous patients.
It is intended for
single use only. It is
intended for delayed
loading. | The MS SA Implant
System (Narrow
Ridge) is intended to
use in the treatment
of missing
mandibular central
and lateral incisors to
support prosthetic
device, such as
artificial teeth, in
order to restore
chewing function in
partially edentulous
patients. The MS SA
Implant (Narrow
Ridge) is intended for
single use only. It is
intended for delayed
loading. | The MS Implant
System (Narrow
Ridge) is intended to
use in the treatment
of missing
mandibular central
and lateral incisors to
support prosthetic
device, such as
artificial teeth, in
order to restore
chewing function in
partially edentulous
patients. MS Implant
(Narrow Ridge) is
intended for single
use only. It is
intended for delayed
loading | The HIOSSEN
Implant System is
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
restorations, and final
or temporary
abutment support for
fixed bridgework. It is
intended for delayed
loading. Ultra wide
Fixture System is
intended to be used |
6
Image /page/6/Picture/0 description: The image shows the Hiossen Implant logo. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in gray below "Hiossen". There is a registered trademark symbol next to the word "Hiossen".
| in the molar region. | ||||
|---|---|---|---|---|
| Structure | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2.5/4mm gingival | ||||
| height neck | ||||
| • Integrated abutment | ||||
| head | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2.5/4mm gingival | ||||
| height neck | ||||
| • Integrated abutment | ||||
| head | • Threaded Body | |||
| Design | ||||
| • One Body Implant | ||||
| • 2/4mm gingival | ||||
| height neck | ||||
| • Integrated abutment | ||||
| head | • Internal Hex- | |||
| connected | ||||
| • Submerged Fixture | ||||
| • Tapered body | ||||
| shape & Straight | ||||
| body shape | ||||
| Thread | ||||
| Diameters | 2.5, 3.0 | 2.5, 2.9 | 2.5, 3.0 | 3.5~6.8 |
| Thread | ||||
| Lengths | 8.5, 10.0, 11.5, 13.0, | |||
| 15.0 | 8.5,10.0, 13.0, 15.0 | 8.5, 10.0, 13.0, 15.0 | 6.2~18.2 | |
| Material | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Titanium alloy Ti-6Al- | |||
| 4V (ASTM F 136) | Pure Titanium Grade | |||
| 4 (ASTM F67) | ||||
| Surface | - SA(Sandblasted | |||
| and Acid etched) | - SA(Sandblasted | |||
| and Acid etched) | RBM (Resorbable | |||
| Blast Media) | - SA(Sandblasted | |||
| and Acid etched) | ||||
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Packaging | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| tamper-evident outer | ||||
| package. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| outer box. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| outer box. | Secured in plastic | |||
| ampule, housed in | ||||
| Tyvek-lidded blister | ||||
| tray, placed in a | ||||
| tamper-evident outer | ||||
| package. | ||||
| S.E. | The proposed device is substantially equivalent with respect to the intended use, structure, | |||
| material, surface, sterilization and design with the legally marketed primary predicate device | ||||
| as well as the surface, sterilization and packaging of the legally marketed reference device. | ||||
| The slight difference in thread diameter and length is a simple size addition. The proposed | ||||
| device does not pose any new or increased risks as compared to the legally marketed primary | ||||
| predicate and reference devices |
Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Biocompatibility Testing
The EM SA Implant System is manufactured using the same manufacturing process and same well known and well established material as the primary predicate device, the MS SA Implant System, K122171, therefore we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EM SA Implant System. Furthermore, as described in International Standard Organization (ISO) standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing when a new material is used that has not been identified in a primary predicate device. The proposed device is manufactured from standard raw material that is used in the primary predicate device and other currently marketed dental implant system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.
7
Image /page/7/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a sans-serif font, with the "H" in red and the rest of the letters in gray. There is a red curved line above the "H". Below "Hiossen" is the word "IMPLANT" in smaller gray letters. There is a registered trademark symbol next to the word "Hiossen".
ww.hiossen.com
Sterilization Validation
The EM SA Implant System (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the primary predicate device, the MS SA Implant System, K122171 and validated following ISO 11137 [2006] Sterilization of health care products - Requirements for Validation and Routine control - Radiation Sterilization quidelines, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the EM SA Implant System.
Shelf Life
The EM SA shelf life is identical to the reference device HIOSSEN Implant System which has been validated for eight (8) years following ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. The EM SA utilizes the exact same packaging materials & methods and is a medical grade titanium, nonmechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf life period. Therefore, no shelf-life validation or accelerated aging testing was performed.
Surface Treatment Characterization Testing
The EM SM Implant System is manufactured using the same manufacturing process, material and well known and well established surface treatment, SA (Sand blasted, Acid etched) as the predicate device, the MS SA Implant system, K122171, therefore no additional character testing was necessary to support the equivalency of the EM SA Implant System.
Fatique Testing
The EM SA Implant System is manufactured using the same manufacturing process, material and very similar design, as the MS SA which was fatique tested in accordance with ISO 14801:2003 Dentistry -Fatigue Test for Endosseous Dental Implants, we reason it was not necessary to re-test fatigue.
Clinical Performance Testing
No clinical performance report(s) is being submitted.
(7) Conclusion:
In accordance with the Federal Food Drug and Cosmetic Act, 21 CFR Part 807, and based on the data and information provided in this premarket notification, the proposed device, EM SA Implant System has established substantially equivalency to the primary predicate and reference device. An extensively comparison of the same design, intended use, structure, general shape and size, material and application method confirms the EM SA share many similarities with the primary predicate MS SA Implant System (K122171) and utilize the same sterilization method and packaging materials to the reference device Hiossen Implant System (K140934). The additional thread diameter and length is a simple size addition, a risk and mitigation measure for root-form endosseous dental implant in a FMEA risk analysis did not disclose any safety or health risk.