(192 days)
The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.
SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation. It consists of Cover screw, Healing Abutment, Solid Abutment, Dual Abutment, Abutment Screw, SCA Abutment, Dual Milling Abutment, Angled Abutment (15° and 25°), Direct casting Abutment-Gold, Metal-Casting Abutment-Co-Cr, Temporary Abutment-Ti and Screw Abutment. All of abutment designs are based on existing Implantium that are cleared for marketing in the United States. The materials of the SimpleLine II Abutment System is Ti-6Al-4V ELI alloy(ASTM F136), Pure Titanium Gr4(ASTM F67). Gold alloy, Co-Cr-Mo (ASTM F799), Ti-Gr2(ASTM F67).
The Angled Abutments are available in diameters of 3.8, 4.3, 4.5, 5.5 and 6.5mm with 15° and 25° angles to the axis of the implant.
This document describes regulatory approval for a dental abutment, not an AI/ML powered device. As such, there is no information about acceptance criteria, study details, or ground truth related to AI/ML performance.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and performance testing, typical for medical device submissions that are not AI/ML driven.
Therefore, the requested information regarding AI/ML device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set specifics cannot be extracted from the provided text.
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JAN 2 6 2012
Dentium
510(k) Summary
2011.12.02
1. Company and Correspondent making the submission
| Company | Dentium Co., Ltd. |
|---|---|
| Address | 27-5 Iui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-766, Korea |
| Contact | Jonghyun, Choi / R&D |
| eastman@dentium.com | |
| Phone | +82 31 207 2200 |
| Fax | +82 31 207 3883 |
2. Device Name
| Proprietary name: | SimpleLine II Abutment System |
|---|---|
| Common name: | Abutment |
| Classification name: | Abutment, Dental, Endosseous implantNHA. 21CFR872.3630 |
3. Predicated Device
Implantium Prosthetics, Dentium Co., Ltd. (K070228, K052957) Implantium, Dentium Co., Ltd. ( K041368)
4. Device Description
ﭘﺮ ﺗ
SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation. It consists of Cover screw, Healing Abutment, Solid Abutment, Dual Abutment, Abutment Screw, SCA Abutment, Dual Milling Abutment, Angled Abutment (15° and 25°), Direct casting Abutment-Gold, Metal-Casting Abutment-Co-Cr, Temporary Abutment-Ti and Screw Abutment. All of abutment designs are based on existing Implantium that are cleared for marketing in the United States. The materials of the SimpleLine II Abutment System is Ti-6Al-4V ELI alloy(ASTM F136), Pure Titanium Gr4(ASTM F67). Gold alloy, Co-Cr-Mo (ASTM F799), Ti-Gr2(ASTM F67).
The Angled Abutments are available in diameters of 3.8, 4.3, 4.5, 5.5 and 6.5mm with 15° and 25° angles to the axis of the implant.
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entium
| Trade name | SimpleLine IIAbutment | ImplantiumProsthetics | ImplantiumProsthetics | Implantium |
|---|---|---|---|---|
| Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. |
| 510(k)Number | New device | K052957 | K070228 | K041368 |
| Materials | Titanium, TitaniumAlloy, Co-Cr, GoldAlloy | Titanium, TitaniumAlloy, Gold Alloy | Titanium, TitaniumAlloy | Titanium, TitaniumAlloy |
| Form | Abutment, Dental,Endosseousimplants | Abutment, Dental,Endosseousimplants | Abutment, Dental,Endosseousimplants | Implant, endosseous,root-form |
| Indicationsfor use | Intended for use as anaid in prostheticrehabilitation. | SAME | SAME | Implantium is intendedto be surgically placedin the bone of the upperor lower jaw arches toprovide support forprosthetic devices, suchas artificial teeth, and torestore the patient'schewing function. |
| Use | Prescription | Prescription | Prescription | Prescription |
5. Substantial Equivalence:
The comparison between SimpleLine II Abutment and other predicated devices is claimed to be substantially equivalence in terms of indication for use, materials, product form, technology, and performance specifications.
The difference between SimpleLine II Abutment and predicate devices are the product shape and slight mechanical and physical characteristics. However, the slight differences do not affect to the application of the device. Therefore, we state that SimpleLine II Abutment system is substantially equivalent to the predicate devices.
6. Indication for Use
The SimpleLine II Abutment system is intended for use as an aid in prosthetic rehabilitation.
7. Performance Testing
Biocompatibility testing on the proposed SimpleLine II Abutment has been completed. Requirements for biological evaluation of the proposed device were based on the 10(k) Summary Page 2 of 3
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entium
ISO7405(2008), "Dentistry-Evaluation of biocompatibility of medical devices used in dentistry." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:
-ISO Cytotoxicity
-ISO Pyrogenicity
-ISO Sensitization
-ISO Intracutaneous reactivity
The proposed SimpleLine II Abutment was evaluated using the following performance bench testing to confirm the performance characteristics:
ISO Static compressive -Torque Force
-ISO Fatigue -Adaptation Accuracy
ISO Systemic toxicity
8. Review
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the SlimpleLine II Abutment system met the established specifications necessary for consistent performance according to its intended use.
SimpleLine II Abutment 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.
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 Dentium Co., Ltd. concludes that the SimpleLine II Abutment System is substantially equivalent to the predicate devices as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
Mr. Jonghyun Choi Assistant Manager Dentium Company, Limited 27-5 lui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do Republic of KOREA 443-270
Re: K112045
Trade/Device Name: SimpleLine II Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: NHA Dated: January 13, 2012 Received: January 17, 2012
Dear Mr. Choi:
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.
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Page 2 - Mr. Choi
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 vours.
Susan Reonne
Anthony D. Watson, B.S., M.S., M.S., M.B.A. 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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Dentium
Indications for Use
510(k) Number: K112045
Device Name:
SimpleLine II Abutment system
Indications for Use:
The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
..
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112045
§ 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.)