(202 days)
HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The HS/HG Prosthetic System is device made of 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 provided text describes a 510(k) summary for the HS/HG Prosthetic System, a dental device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new device.
Therefore, the document does not contain information on:
- A table of acceptance criteria and reported device performance for specific thresholds.
- Sample sizes used for a test set or data provenance for a performance study.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, etc.) for performance evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the submission focuses on:
Study and Evidence Presented:
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Substantial Equivalence Matrix: The submission directly compares the HS/HG Prosthetic System to two predicate devices:
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Safety, Performance, and Product Validations (General Statement): The document states: "The 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." However, specific details of these validations (e.g., acceptance criteria, test results) are not provided in the summary.
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Fatigue Testing:
- Test Performed: 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."
- Worst-Case Scenario: The testing was done using a "worst case scenario."
- Result: "The fatigue test result were Similar to previously cleared predicate device." This indicates a comparative approach rather than meeting specific pre-defined numerical acceptance criteria for fatigue.
Conclusion:
The main conclusion presented is that the HS/HG Prosthetic System is substantially equivalent to the predicate devices based on the information provided, including similar material, indication for use, design, technological characteristics, and comparable fatigue test results. This type of submission relies on demonstrating similarity to a previously cleared device, rather than establishing de novo performance against a new set of criteria.
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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: January 8, 2010
- 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 - Telephone No. : 82-51-850-2574 - Contact : Mr. JongHyuk Seo
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- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
HS/HG Prosthetic System Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
3. Predicate Device :
The HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. K081575 The Ziocera & Convertible System, Osstem Implant Co., Ltd, K081786
4. Description :
- l ) The HS/HG Prosthetic System is device made of 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.
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- The 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.
QS-Q1-505-3(Rev.0)
Letter(8.5 X 11in),
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Image /page/1/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 bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. There is a small degree symbol to the right of the word "OSSTEM".
#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
- Substantial Equivalence Matrix
| HS/HG ProstheticSystem | HU/HS/HG ProstheticSystem (K081575) | Ziocera & ConvertibleSystem (K081786) | |
|---|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k)Number | New | K081575 | K081786 |
| Intended use | HS/HG ProstheticSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. | HU/HS/HG ProstheticSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. | Ziocera & ConvertibleSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. |
| Packaging | Polymeric Ampoule in afoil backed peel openblister pack | Polymeric Ampoule in afoil backed peel openblister pack | Polymeric Ampoule in afoil backed peel openblister pack |
| Sterilization | Healing Abutment -Radiation SterileAbutment -- Non-Sterile | Healing Abutment -Radiation SterileAbutment - Non-Sterile | Non-Sterile |
| Shelf life | 5 years | 5 years |
5. Indication for use :
HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6. Review :
The HS/HG Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.
The 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.
7. Summary of nonclinical testing
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" with the worst case scenario. The fatigue test result were Similar to previously cleared predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, black letters, with a small circle above the "M". Below "OSSTEM" is the word "IMPLANT" in smaller, black letters. The logo is simple and professional.
OSSTEM Implant Co., Ltd #507-8 Geoje3-Dong Yconje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
8. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the HS/HG Prosthetic System is substantially equivalent to the predicate device as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
AUG 17 2010
Re: K100245
Trade/Device Name: HS/HG Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 11, 2010 Received: August 13, 2010
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.
Image /page/3/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
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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,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, and General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OSSTEM Implant Co., Ltd. OSSTEM #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 LOO 245
Device Name : HS/HG Prosthetic System
Indication for use : 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)
ASBatz DDS for Dri. RPMuly
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100245
QS-QI-505-2(Rev.0)
§ 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.)