(98 days)
Not Found
No
The summary describes a physical dental implant made of titanium and its mechanical testing. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is intended to restore the patient's chewing function, which is a therapeutic purpose.
No
The device, SimpleLine II, is described as a dental fixture intended for surgical placement to support prosthetics and restore chewing function. Its purpose is to treat or replace a missing body part, not to diagnose a condition.
No
The device description explicitly states it is a dental fixture made of pure titanium metal, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- SimpleLine II Function: The SimpleLine II is a dental implant that is surgically placed inside the body (in the jawbone) to support prosthetics. It is a structural device, not a diagnostic test.
The description clearly states its purpose is to be surgically placed in the bone to support prosthetics and restore chewing function. This is a therapeutic and structural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery
Product codes
DZE
Device Description
The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
Test performed in air at 24℃, at 14Hz frequency for at least 5x106 cycles. Tilting angles of specimen is 30. Applied loads are 597N, 448N, 299N, 250N. The fatigue limit is over 250N (Fracture or cracks or severe distortion of any parts were not detected. It is the same fatigue limit of predicate device Implantium II.
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.
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
§ 872.3640 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
¥102308
NOV 2 2 2010
Dentium ______________________________________________________________________________________________________________________________________________________________________
510(k) Summary
28th July, 2010
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 27-5 Iui-dong, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-766, Korea |
| Phone / Fax | +82 31 207 2200 / +82 31 207 3883 |
| Contact person | Lee, Sungwon / R&D |
| swlee@implantium.com |
2. Device Name
| Proprietary name: | SimpleLine II |
|---|---|
| Common name: | Endosseous Dental Implant |
| Classification name: | Implant, Endosseous, Root-Form |
| DZE, 21CFR872.3640 |
3. Predicated Device
Dentium Co., Ltd / Implantium II K060501
4. Description
The SimpleLine II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The SimpleLine II 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 differences between them are shape and shelf life.
The SimpleLine II is substantially equivalent in design, function, surface treatment, material and intended use to the fixture of Dentium Co., Ltd. Implantium II
1
Dentium ______________________________________________________________________________________________________________________________________________________________________
5. Indication for Use
The SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function.
6. Performance Testing
Test performed in air at 24℃, at 14Hz frequency for at least 5x106 cycles. Tilting angles of specimen is 30. Applied loads are 597N, 448N, 299N, 250N. The fatigue limit is over 250N (Fracture or cracks or severe distortion of any parts were not detected. It is the same fatigue limit of predicate device Implantium II.
7. Review
SimpleLine II has the same device characteristics as the predicate device Implantium The material, surface treatment is same and the design, use concept is similar. II.
8. 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 SimpleLine II is safe and effective and substantially equivalent to predicate device as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized symbol with three curved lines, possibly representing people or services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dentium Company. Limited C/O Mr. Eunk Zyung Son Dentium USA 6761 Katella Avenue Cypress, California 90630
NOV 2 2 2010
Re: K102308
Trade/Device Name: SimpleLine II Regulation Number: 21 CFR 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 9, 2010 Received: November 12, 2010
Dear Mr. Son:
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.
3
Page 2- Mr. Son
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.goy/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hh for
Anthony D. Watson, B.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
4
NOV 2 2 2 2010
Dentium
Indications for Use
510(k) Number:
SimpleLine II Device Name: .
Indications for Use:
SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery
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)
Jh
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102308