(116 days)
Not Found
No
The document describes a dental implant made of titanium alloy and its intended use for supporting prosthetic devices. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as a dental implant system that restores chewing function and supports prosthetic devices, which are clear therapeutic actions.
No
The device description indicates that the MS SA Implant System is a dental implant intended to restore chewing function by supporting prosthetic devices. Its purpose is to provide support, not to diagnose conditions.
No
The device description clearly states the device is a dental implant made of titanium alloy, which is a hardware component.
No, 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 intended to be placed in the bone of the jaw to support prosthetic devices and restore chewing function. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a titanium alloy dental implant with a specific surface treatment. This aligns with a medical device intended for implantation, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory tests
The device described is a medical device, specifically a dental implant.
N/A
Intended Use / Indications for Use
The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.
The MS SA Implant (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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS 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. The surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching).
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)
Summary of nonclinical testing: Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the MS SA Implant system.
Summary of clinical testing: No clinical studies are 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.
Not Found
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
DSSTEM 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
510(k) Summary
NOV 1 6 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 13, 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
MS SA Implant System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
3. Predicate Device:
MS System, OSSTEM Implant Co., Ltd, K083067 Straumann Dental Implants, Institut Straumann AG, K061176
4. Description:
The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS 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. The surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching).
1
Image /page/1/Figure/1 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, the fax number is +82 51 850-4341, and the website is www.osstem.com.
The MS SA Implant System is substantially equivalent in design, function and intended use to the MS System, OSSTEM Implant Co., Ltd, K083067
The MS SA Implant System is substantially equivalent in surface treatment to the Straumann Dental Implants, Institut Straumann AG, K061176
| | MS SA Implant System
(Narrow Ridge) | Predicate devices | |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MS System
(Narrow Ridge) | Straumann Dental
Implants |
| Design | Image: MS SA Implant System (Narrow Ridge) | Image: MS System (Narrow Ridge) | Image: Straumann Dental Implants |
| 510(K) No. | New device | K083067 | K061176 |
| Intended use | The MS SA Implant (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 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 System
(Narrow Ridge) are
intended for single use
only. | Straumann Regular Neck
and Narrow Neck implants
are intended for immediate
placement and function on
single-tooth and/or multiple
tooth applications when
good primary stability is
achieved, with appropriate
occlusal loading, in order to
restore chewing function.
Multiple tooth applications
may be rigidly splinted. In
the case of edentulous
patients, four or more
implants must be used.
The Straumann Regular
Neck Implants are intended
for surgical placement in
the maxillary and/or
mandibular arches to
provide support for
prosthetic restorations
in edentulous or partially
edentulous patients. |
| Structure | | | |
| - SA(Sandblasting and Acid etching).
- Threaded Body Design
- One Body Implant | | - R.B.M (Resorbable Blasting Media).
- Micro Thread Design.
- Threaded Body Design
- One Body Implant | -Single Thread
-Straight body Type
-Non-submerged fixture |
| Thread body
Diameter (D) | 2.5, 2.9 | 2.5, 3.0 | 3.34.8 |16.0 |
| Length (mm)
of thread | 8.5, 10.0, 11.5, 13.0 | 8.5, 10.0, 11.5, 13.0, 15.0 | 6.0
| Material of
Fixture | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Pure Titanium Grade 4
(ASTM F67) |
| Surface | SA(Sandblasting and Acid
etching). | R.B.M (Resorbable
Blasting Media). | SLA(Grit blasting, acid
etched SLA surface) |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S E | The MS SA Implant System (Narrow Ridge) has the same material, indication for use and similar design as the MS System (Narrow Ridge) (K083067) except surface treatment. but the surface treatment of The MS SA Implant System (Narrow Ridge) is the similar with surface treatment of Straumann Dental Implants (K061176) | | |
| | MS SA Implant System
(Denture) | Predicate devices | |
| | | MS System
(Denture) | Straumann Dental
Implants |
| | Design | Image: MS SA Implant System (Denture) | Image: MS System (Denture) |
| 510(K) No. | New device | K083067 | K061176 |
| Intended use | The MS SA Implant
(Denture) is intended to be
placed in the bone of the
upper or lower jaw arches to
provide support of the
prosthetic devices to restore
the patient's chewing
function, including the
denture stabilization. The
MS SA Implant (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. MS System
(Denture) is intended for
single use only. | Straumann Regular Neck
and Narrow Neck implants
are intended for immediate
placement and function on
single-tooth and/or multiple
tooth applications when
good primary stability is
achieved, with appropriate
occlusal loading, in order to
restore chewing function.
Multiple tooth applications
may be rigidly splinted. In
the case of edentulous
patients, four or more
implants must be used.
The Straumann Regular
Neck Implants are intended
for surgical placement in
the maxillary and/or
mandibular arches to
provide support for
prosthetic restorations
in edentulous or partially
edentulous patients for
single-stage or two-stage
surgery. The Straumann
Narrow Neck implants are
intended for surgical
placement in the maxilla or
mandible to serve as a base
for prosthetic
reconstructions.
Specifically, the Narrow |
| | | | Neck implant is indicated
for replacement of single
lateral incisors in the
maxilla and lateral and
central incisors in the
mandible. It is particularly
intended for those areas
where the interdental space
is extremely limited
(minimum 5 mm) and
where vestibule-oral bone is
restricted (minimum 5 mm).
The Narrow Neck implant
can also be used as a
support for a full arch
implant-born restoration,
but only in conjunction with
a standard Straumann 4.1
mm dental implant. |
| Structure | - SA(Sandblasting and Acid
etching). - Ball-shaped suits for
O-Ring attachment. - 2/4mm can be used
according to gingival
height. - Threaded Body Design | - R.B.M (Resorbable
Blasting Media). - Ball-shaped suits for
O-Ring attachment. - 2/4mm can be used
according to gingival
height. - Micro Thread Design.
- Threaded Body Design | -Single Thread
-Straight body Type
-Non-submerged fixture |
| Thread body
Diameter (D) | 2.5, 2.9 | 2.0, 2.5, 3.0 | 3.34.8 |16.0 |
| Length (mm)
of thread | 8.5, 10.0, 11.5, 13.0 | 8.5, 11.5 | 6.0
| Material of
Fixture | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Titanium alloy Ti-6Al-4V
(ASTM F 136) | Pure Titanium Grade 4
(ASTM F67) |
| Surface | SA(Sandblasting and Acid
etching). | R.B.M (Resorbable
Blasting Media). | SLA(Grit blasting, acid
etched SLA surface) |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| SE | The MS SA Implant System (Denture) has the same material, indication for use and similar
design as the MS System (Denture) (K083067) except surface treatment. but the
surface treatment of The MS SA Implant System (Denture) is the similar with surface
treatment of Straumann Dental Implants (K061176) | | |
- Substantial Equivalence Matrix
QS-QI-505-3(Rev.0)
2
Image /page/2/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. There is a registered trademark symbol next to the word "OSSTEM".
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
.
3
OSSTEM°
IMPLANT
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
QS-QI-505-3(Rev.0)
4
Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in bold, sans-serif font on the top line. Below that, the word "IMPLANT" is in a smaller, sans-serif font.
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
5. Indication for use:
·
The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only.
Letter(8.5 X 1 In)
5
Image /page/5/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in a bold, sans-serif font, with the letters slightly overlapping each other. Below the word "OSSTEM", the word "IMPLANT" is written in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants.
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
The MS SA Implant (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.
-
- Review:
The MS SA Implant System has similar material, indication for use, design and technological characteristics as the predicate device.
- Review:
The MS SA 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.
-
- Summary of nonclinical testing
Fatigue testing was considered according to the "Guidance for industry and FDA staff
- Summary of nonclinical testing
Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the MS SA Implant system
-
- Summary of clinical testing No clinical studies are submitted
9. 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 MS SA Implant System is substantially equivalent to the predicate devices as described herein.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus-like design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 16, 2012
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K122171
Trade/Device Name: MS SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 25, 2012 · Received: September 28, 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 Eederal Register.
7
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,
DN: r=US o=1) S. Government ou=HHS 0.9.2342.19200300.100.1.1=1300092402
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
8
K122171
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
510(k) Number K 100217
Device Name : MS SA Implant System
Indication for use : The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.
The MS SA Implant (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.
X Prescription Use (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)
Digitally signed by Mary S. Runn Marv S. Runner DA. Ou=People, cn=Mary 5, Run
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
- 】 -
510(k) Number: K12217 1
OS-QI-505-2(Rev.0)