(184 days)
Not Found
No
The document describes a dental implant made of metal and its intended use, material, and surface treatment. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is described as intended for "treatment of missing mandibular central and lateral incisors" to "restore chewing function," which indicates a therapeutic purpose.
No
The device is a dental implant intended to restore chewing function, not to diagnose a condition.
No
The device description explicitly states it is a dental implant made of Ti-6Al-4V metal, 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 the device is for the treatment of missing teeth by supporting prosthetic devices to restore chewing function. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a dental implant made of metal, designed to be surgically placed in the jawbone. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The MS System (Narrow Ridge) is a dental implant made of Ti-6Al-4V metal. The MS System (Narrow Ridge) 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 System (Narrow Ridge) is of R.B.M (Resorbable Blasting Media).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MS System (Narrow Ridge) 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.
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.
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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/1 description: This 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.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 21, 2008
- Company and Correspondent making the submission:
| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | #507-8 Geoje3-Dong Yeonje-Gu |
| Busan, 611-804, Republic of Korea | |
| - Contact : | Mr. JongHyuk Seo |
-
- Device :
Trade or (Proprietary) Name : Common or usual name :
- Device :
Classification Name :
MS System (Narrow Ridge) Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
3. Predicate Device :
Zimmer One-Piece Implants, Zimmer Dental Inc. (K071235). NobelDirect® 3.0, Nobel Biocare USA LLC. (K070857) MS System (Denture), OSSTEM Implant Co., Ltd. (K072959)
- Description :
The MS System (Narrow Ridge) is a dental implant made of Ti-6Al-4V metal.
The MS System (Narrow Ridge) 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 System (Narrow Ridge) is of R.B.M (Resorbable Blasting Media).
The MS System (Narrow Ridge) is substantially equivalent in design, function and intended use to the Zimmer One-Piece Implants of Zimmer Dental Inc, (K071235), NobelDirect® 3.0 of Nobel Biocare USA LLC, (K070857) and MS System (Denture) of OSSTEM Implant Co., Ltd, (K072959)
1
Image /page/1/Picture/0 description: The image shows a logo with a circular design above the word "osstem". The circular design appears to be composed of two incomplete rings, creating a sense of movement or orbit. The word "osstem" is written in a simple, sans-serif font, positioned directly below the circular graphic.
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 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.
6. Review :
The MS System (Narrow Ridge) has similar material, indication for use, design and technological characteristics as the predicate device.
The MS System (Narrow Ridge) 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. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the MS System (Narrow Ridge) is safe and effective and substantially equivalent to the predicate device as described herein
2
Image /page/2/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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2008
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem, Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K080594
Trade/Device Name: MS System (Narrow Ridge) Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 25, 2008 Received: July 29, 2008
Dear Mr. Kim:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Kim
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
OK Samuels-Landrum for 11
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 080594
Image /page/4/Picture/1 description: The image shows the logo for Osstem. The logo consists of a circular design with two curved shapes that intertwine to form a ring. Below the circular design, the word "osstem" is written in lowercase letters.
Osstem, Inc. One Ben Fairless Dr. Fairless Hills, PA 19030 Tel: 215.736.2990 / Fax: 215.736.2993 www.osstem.com
Attachment III
Indications for Use statement
510(k) Number K
Device Name: MS System (Narrow Ridge)
Indication for use : 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 and not for immediate loading.
Prescription Use X OR Over-The-Counter Use . (Per 21CFR801 Subpart D) (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 Ramsey
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080594