(161 days)
Not Found
No
The summary describes a physical dental implant system made of Zirconia and Titanium components. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven analysis that would indicate the use of AI/ML technology.
No
This device, described as an abutment system for dental implants, is intended to support prosthetic restorations and does not actively treat a disease or condition.
No
The device is a dental implant system designed to provide support for prosthetic restorations. Its purpose is structural and restorative, not to diagnose a condition.
No
The device description explicitly states it is made of Zirconia and Titanium and consists of physical components (Abutment, Cylinder, and Abutment Screw), indicating it is a hardware medical device.
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 providing support for prosthetic restorations with a dental implant. This is a mechanical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the materials (Zirconia and Titanium) and components (Abutment, Cylinder, Abutment Screw), which are all physical parts used in a surgical or restorative procedure.
- 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.
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 Ziocera & Convertible Systems are 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 Ziocera & Convertible Systems are device made of Zirconia and Titanium intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutment, Cylinder and Abutment Screw.
The Ziocera & Convertible Systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
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 Ziocera & Convertible Systems have 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.
K023631, K991947, K072624, 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
DEC 0 2 2008
Image /page/0/Picture/1 description: The image shows a logo with the word "osstem" in lowercase letters. Above the word is a circular graphic design. The graphic design appears to be a stylized representation of a globe or sphere, with curved lines forming a circular shape.
OSSTEM Implant Co., Ltd #507-8 Geoie3-Dong Yeonie-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 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: June 5, 2008
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
OSSTEM Implant Co., Ltd.
#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 :
Classification Name :
Ziocera & Convertible System Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
- Predicate Device :
The ZirDesign Abutment, ASTRA Tech . INC. K023631 The Zireal Post, 31 Ceramic Abutment System Implant Innovations. INC, K991947 The Titanium Cylinder, ASTRA Tech AB, K072624 The US Angled Abutment, Osstem Implant Co., Ltd, K073247
- Description :
The Ziocera & Convertible Systems are device made of Zirconia and Titanium intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutment, Cylinder and Abutment Screw.
The Ziocera & Convertible Systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The Ziocera & Convertible Systems are substantially equivalent in design, function and intended use to the ZirDesign Abutment (K023631) of ASTRA Tech. INC. Zireal Post (K991947) of 31 Ceramic Abutment System Implant Innovations. INC. Titanium Cylinder
- 1 -
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
1
(K072624) of ASTRA Tech AB and US Angled Abutment (K073247) of Osstem Implant Co., Ltd.
-
- Indication for use :
The Ziocera & Convertible Systems are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
- Indication for use :
-
- Review :
The Ziocera & Convertible Systems have similar material, indication for use, design and technological characteristics as the predicate device.
- Review :
The Ziocera & Convertible Systems have 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 Ziocera & Convertible Systems are safe and effective and substantially equivalent to the predicate device as described herein.
08 1776
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 stylized eagle emblem on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem. The text is in all caps and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osstem Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K081786
Trade/Device Name: Ziocera & Convertible System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 24, 2008 Received: November 28, 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.
DEC 0 2 2008
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 (OS) 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 vours.
C.W. Li, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the Osstem logo. The logo consists of a stylized circle above the word "osstem". The circle is made up of thick, black lines that overlap and intersect. The word "osstem" is written in a simple, sans-serif font, with a line underneath it.
QSSTEM 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
Device Name: Ziocera & Convertible System
Indication for use : Ziocera & Convertible Systems are 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)
Over-The-Counter Use OR (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)
Robert Bertz DDS for Dr. Susan Renner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081786
QS-QI-505-2(Rev.0)