(143 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
No
This device is a dental implant system used for prosthetic restorations in the mouth, not for treating a disease or health condition.
No
This device is a dental implant system used for prosthetic restorations in partially or fully edentulous patients. It is surgically placed and supports crowns, bridges, or overdentures, which are all treatment (restorative) functions, not diagnostic ones.
No
The device description clearly states it is a dental implant system made of titanium metal, which is a physical hardware device, not software.
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 dental implant system for surgical placement in the bone of the jaw to support prosthetic restorations. This is a surgical and prosthetic device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and components of a dental implant and abutment, which are physical devices implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are 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 ET/SS 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.
Product codes
DZE, NHA
Device Description
The ET/SS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae (upper or lower jaw arches)
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
Summary of nonclinical testing: The Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices.
Summary of clinical testing: No clinical studies are submitted.
Key Metrics
Not Found
Predicate Device(s)
K080387, K101096, K083633, K110308, K081786, K081575
Reference Device(s)
Not Found
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
Kiaosyz
510(k) Summary
AUG 1 0 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: March 16, 2012
- Company and Correspondent making the submission:
- Submitter's Name :
- Address :
- Contact :
- Phone:
- Correspondent's Name:
- Address:
- Contact:
- Phone:
-
- Device :
Trade or (Proprietary) Name : Common or usual name :
Classification Name :
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575
HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001
ET/SS Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
3. Predicate Device:
The HU II / HS II Fixture System, Osstem Implant Co., Ltd, K080387 The ET III SA Fixture System, HIOSSEN Inc., K101096 The HS II Short Fixture System, Osstem Implant Co., Ltd, K083633 The Prosthetic System, Osstem Implant Co., Ltd., K110308 The Ziocera & Convertible System, Osstem Implant Co., Ltd., K081786 The HU.HS.HG Prosthetic System, Osstem Implant Co., Ltd., K081575
-
- Description:
The ET/SS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
- Description:
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
QS-QI-505-3(Rev.0)
1
Image /page/1/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The telephone number is +82 51 850-2500, and the fax number is +82 51 850-4341. The website address is www.osstem.com.
Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated
The ET/SS 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.
The ET/SS Implant System is substantially equivalent in design, function and intended use to the HU II / HS II Fixture System ( K080387) of Osstem Implant Co., Ltd., the ET III SA Fixture System (K101096) of HIOSSEN Inc. and the HS II Short Fixture System (K083633) of Osstem Implant Co., Ltd,
The Prosthetic System such as abutment and cylinder in the ET/SS Implant System is substantially equivalent in design, function and intended use to the Prosthetic System (K110308) of Osstem Implant Co., Ltd, The Ziocera & Convertible System(K081786) of Osstem Implant Co., Ltd and and The HU.HS.HG Prosthetic System(K081575) of Osstem Implant Co., Ltd.
| | ET/SS Implant
System
(SSII/III SA
Fixture) | Predicate devices | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | HS II Fixture
(K080387) | ETIII SA Fixture
(K101096) | HS Short Fixture
(K083633) |
| Design | Image: ET/SS Implant System | Image: HS II Fixture | Image: ETIII SA Fixture | Image: HS Short Fixture |
| Intended
use | ET/SS 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 | HS II Fixture System
is intended for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple-unit
restorations
including; cemented
retained, | ETIII SA Fixture
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 | HS II Short Fixture
System is intended 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. The abutment
is intended for use with
a dental implant fixture
to provide support for
prosthetic restorations
such as crowns,
bridges, or
overdenture. | screw retained, or
overdenture
restorations, and
terminal or
intermediate
abutment support for
fixed bridgework. It
is not for immediate
load | retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. The ETIII
SA Fixture System is
for single
and two stage surgical
procedures. It is not
for immediate load.
The Ultra wide Fixture
System is intended to
be used in the molar
region. | overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. It is not
for immediate load | |
| Surgery
type | One and two stage
Surgery | One and two stage
Surgery | One and two stage
Surgery | One and two stage
Surgery |
| Structure | Fixture
- Non Submerged
- Self tapping
- Internal Octagonal
connection - Straight Body | Fixture
- Non Submerged
- Self tapping
- Internal Octagonal
connection - Straight Body | - Submerged Fixture
- Self tapping
- Internal Hexagonal
connection - Taper Body | Fixture
- Non Submerged
-Straight Body Type
-Self tapping
-Internal Octagonal
connection |
| Platform
(D) | 4.86.0 | 3.56.0 | N/A | 5.07.0 |4.9/3.75
| Body
Diameter
(D) | 4.15.0 | 3.55.0 | 3.55.0 | 4.95 ~ 6.85 |15.0 | 8.5
| Length
(mm) | 615.0 | 7.015.0 | 6.0 |
| Material
of Fixture | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium Grade
4 (ASTM F67) | Pure Titanium Grade 4
(ASTM F67) | Pure Titanium Grade 4
(ASTM F67) |
| Surface | SA | RBM | SA | RBM |
| Packagin
g | Polymeric Ampoule in
a foil backed peel open
blister pack | Polymeric Ampoule
in a foil backed peel
open blister pack | Polymeric Ampoule in
a foil backed peel
open blister pack | Polymeric Ampoule in
a foil backed peel
open blister pack |
| Sterilizati
on | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Shelf life | 5 years | 3 years | 5 years | 5 years |
| SE | SSII/III SA Fixture has the same material, indication for use and similar design as the HSII Fixture
in the HU II / HS II Fixture System (K080387) except surface treatment, but the surface treatment
of SS SA Fixture is the same with surface treatment of ETIII SA Fixture System (K101096) | | | |
- Substantial Equivalence Matrix
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
2
Image /page/2/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
- Indication for use :
The ET/SS 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. The abutment is intended for use with
Letter(8.5 X 11in)
3
Image /page/3/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in bold, sans-serif font on the top line. Below it, the word "IMPLANT" is written in a smaller, sans-serif font. There is a small circle above and to the right of the "M" in "OSSTEM".
OSSTEM Implant Co., L #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.
-
- Review :
The ET/SS Implant System has same material and indication for use and similar design and technological characteristics as the predicate device.
- Review :
The ET/SS Implant System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
7. Summary of nonclinical testing
The Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices."
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the ET/SS Implant System is substantially equivalent to the predicate devices as described herein
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 0 2012
OSSTEM Implant Company, Limited C/O HIOSSEN, Incorporated Mr. Patrick Lim . 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K120847
Trade/Device Name: ET/SS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 29, 2012 Received: July 11, 2012
Dear Mr. Lim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2- Mr. Lim
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DSSTEM Implant Co., L #507-8 Geoje3-Dong Yeonie-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Number K _
Device Name : ET/SS Implant System
Indication for use : The ET/SS 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.
Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruerner
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K120847
QS-QI-505-2(Rev.0)