(168 days)
No
The summary describes a physical dental implant and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a temporary support for a provisional prosthetic device during the healing phase of a permanent dental implant, indicating a therapeutic purpose.
No
Explanation: The device, EM Provisional, is a temporary dental implant used as a support for provisional prosthetic devices during the healing phase after permanent dental implant placement. Its function is structural support, not to identify or determine a disease or condition.
No
The device description explicitly states it is a dental implant made of titanium alloy, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a temporary support for a provisional prosthetic device during the healing phase of dental implants. This is a surgical and mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a dental implant made of titanium alloy, intended for surgical placement in bone. This aligns with a medical device used for structural support, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).
Product codes
DZE
Device Description
The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.
The EM Provisional 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 MS System (Provisional), OSSTEM Implant Co., Ltd, K072871
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxilla
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
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Biocompatibility Testing
Sterilization Validation
Surface Treatment Characterization Testing
Fatique Testing
Compressive Strength Testing
Pull-out Testing
No clinical performance report(s) is being submitted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2019
Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K191751
Trade/Device Name: EM Provisional Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 16, 2019 Received: September 17, 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 Part 803) for devices or post marketing 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 (QS) 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 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.
for
Srinivas Nandkumar, Ph.D. 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 stylized font, with the "H" in red and the rest of the letters in gray. There is a red swoosh 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)
Device Name EM Provisional
Indications for Use (Describe)
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).
Type of use (Select one or both, as applicable)
区 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
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Image /page/3/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The word "Implant" is written in gray letters below the word "Hiossen."
5 Ben Fairless Drive Hills, PA 19030 www.hiossen.com
Section 6 510(k) Summary - 4 PAGES
| (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 8, 2019 |
| (2) Device Name:
· Proprietary Name:
• Classification Name:
• CFR Number:
• Device Class:
• Product Code: | EM Provisional
Implant, Endosseous, Root-form
872.3640
Class II
DZE |
(3) Predicate Device:
| Device | 510(k) | Manufacturer |
|---|---|---|
| MS System (Provisional) | K072871 | OSSTEM Co., Ltd. |
| Hiossen Implant System* | K140934 | Hiossen, Inc. |
*Reference device
(4) Description of Device:
The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.
The EM Provisional 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 MS System (Provisional), OSSTEM Implant Co., Ltd, K072871
| Device | Diameter(mm) | Thread Length(mm) |
|---|---|---|
| EM Provisional | Ø1.8, Ø2.5 | 10.0, 13.0, 15.0 |
(5) Indication For Use:
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).
4
Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The "H" and the top part of the "i" are red, while the rest of the letters are gray. Below the word "Hiossen" is the word "Implant" in smaller, gray letters.
85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com
(6) Substantial Equivalence:
The information and date provided in this submission established the EM Provisional is substantially equivalent to the primary predicate device, OSSTEM MS System (Provisional) in (510(k) number K072871).
| | Proposed Device
EM Provisional | Predicate Device
MS System (Provisional) | Reference Device
HIOSSEN IMPLANT
SYSTEM |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | EM Provisional | MS System (Provisional) | HIOSSEN IMPLANT
SYSTEM |
| Manufacturer | Hiossen, Inc. | Osstem Co., Ltd. | Hiossen, Inc. |
| 510(K) No. | New device | K072871 | K140934 |
| Design | Image: EM Provisional Design | Image: MS System (Provisional) Design | Image: HIOSSEN IMPLANT SYSTEM Design |
| Intended use | The EM Provisional is
intended to be loaded
immediately in partially or
fully edentulous mandibles
and maxilla to serve as
temporary support for
provisional prosthetic
device during the healing
phase of permanent
endosseous dental
implant(s). | The MS system
(Provisional) is intended to
be loaded immediately in
partially or fully edentulous
mandibles and maxilla to
serve as temporary
support for provisional
prosthetic device during
the healing phase of
permanent endosseous
dental implants. | 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 | • Screw form
• One piece fixture and
abutment | • Screw form
• One-piece of Fixture and
Abutment | • Internal Hex-connected
• Submerged Fixture
• Tapered body shape &
Straight body shape |
| Diameters | 1.8, 2.5 | 1.8, 2.5 | 3.56.8 |18.2 |
| Lengths | 10.0, 13.0, 15.0 | 10.0, 13.0, 15.0 | 6.2
| Material | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Pure Titanium Grade 4
(ASTM F67) |
| Surface | Machined finished | Machined finished | - SA(Sandblasted and
Acid etched) |
| Sterilization | 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
tamper-evident outer
package. |
5
Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the letters "HI" in red, followed by "OSSEN" in gray. The word "IMPLANT" is written in smaller gray letters below the word "OSSEN". There is a registered trademark symbol next to the word "OSSEN".
| S.E. | The proposed device is substantially equivalent with respect to the intended use, structure, material, surface, sterilization and design with the legally marketed predicate device as well as the sterilization and packaging of the legally marketed reference device. The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices. |
|---|---|
| ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Substantial Equivalence Conclusion
In accordance with the Federal Food Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, HIOSSEN, INC. concludes since the EM Provisional has the same design, intended use, structure, diameters, lengths, material, surface, sterilization as the predicate device, MS System (Provisional) (K072871) and same sterilization and packaging to the reference Hiossen Implant System (K140934) it is substantially equivalent. The propose device does not pose any new or increased risk as compared to both the legally marketed 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 Provisional is manufactured using the same manufacturing process and same well known and well established material as the predicate device, the MS System (Provisional), K072871, therefore we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EM Provisional.
Sterilization Validation
The EM Provisional (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 predicate device, the MS System (Provisional), K072871, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the EM Provisional.
Surface Treatment Characterization Testing
The EM Provisional surface is manufactured using the same manufacturing process, material and is its surface is machined finished just as the predicate device, the MS System (Provisional), K072871, therefore no additional character testing was necessary to support the equivalency of the EM Provisional.
Fatique Testing
The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test fatigue on the proposed device since both are the same device.
Compressive Strength Testing
The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test compressive strength on the proposed device since both are the same device.
6
Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters, with the "H" and the top part of the "i" in red, and the rest of the letters in gray. Below the word "Hiossen" is the word "IMPLANT" in gray, with a large amount of space between each letter.
85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com
Pull-out Testing The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test pull-out on the proposed device since both are the same device.
Clinical Performance Testing
No clinical performance report(s) is being submitted.