(89 days)
Not Found
No
The summary describes a physical prosthetic system made of standard materials, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device provides mechanical support for dental restorations, rather than directly treating a disease or condition. While it aids in restorative procedures, its primary function is structural, fitting within the definition of a prosthetic device rather than a therapeutic one.
No
The device description indicates it is a prosthetic system intended to provide support for restorations, not to diagnose a condition.
No
The device description explicitly states it is made of physical materials (titanium, titanium alloy, POM, PC) and consists of physical components (Abutment, Protect Cap, Abutment Screw), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations (crowns, bridges, overdentures) with a dental implant. This is a surgical/implantable device used directly on or in the patient's body.
- Device Description: The description details a physical device made of titanium, POM, and PC, consisting of abutments, caps, and screws. This is consistent with a physical implant component.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component for dental prosthetics.
N/A
Intended Use / Indications for Use
HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. 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
Not Found
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)
The HU/HS/HG Prosthetic 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.
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.
K062030, K062051, K063861, K073247
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows a logo with the word "osstem" in lowercase letters below a circular graphic. The graphic is composed of two curved shapes that partially overlap, creating a sense of movement or rotation. The word "osstem" is in a simple, sans-serif font and appears to be the name of a company or organization.
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
SEP - 2 2008
510(k) Summary
KC81575
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: May 21, 2008
- Company and Correspondent making the submission:
- Submitter's Name :
- Address :
OSSTEM Implant Co., Ltd.
HU/HS/HG Prosthetic System
Mr. JongHyuk Seo
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
- Contact :
Classification Name :
-
- Device :
Trade or (Proprietary) Name : Common or usual name :
- Device :
Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
3. Predicate Device :
The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247
4. Description :
The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.
The HU/HS/HG Prosthetic 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 HU/HS/HG Prosthetic System is substantially equivalent in design, function and intended use to the US System(K062030), SS System(K062051), GS System(K063861) and US/SS/GS System(K073247) of Osstem Implant Co., Ltd.
1
Image /page/1/Picture/0 description: The image shows a logo with the word "osstem" written in lowercase letters. Above the word is a circular design that appears to be composed of several curved lines or shapes, creating a sense of movement or orbit. The logo has a clean and modern aesthetic.
5. Indication for use :
HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
-
- Review :
The HU/HS/HG Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.
- Review :
The HU/HS/HG Prosthetic 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.
-
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the HU/HS/HG Prosthetic System is safe and effective and substantially equivalent to the predicate device as described herein.
- Conclusion :
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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 stylized depiction of a human figure embracing a globe, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 - 2008
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K081575 Trade/Device Name: HU/HS/HG Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Regulatory Class: II Product Code: NHA Dated: May 21, 2008 Received: June 5, 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.
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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.
Thmmuels Leudims. forji
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
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Image /page/4/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo is on the left, with the company name and address on the right. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
510(k) Number K ______________________________________________________________________________________________________________________________________________________________
Device Name: HU/HS/HG Prosthetic System
Indication for use : HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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 Runnes
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 60 8 1575