(113 days)
No
The summary describes a dental implant system and its mechanical properties, with no mention of AI or ML.
No
The device is an implant system used for dental restorations, which is a supportive device rather than a device that directly treats a disease or condition.
No
The device is an implant system used for restorative dentistry (replacing missing teeth), not for diagnosing medical conditions. Its purpose is to support restorations, not to identify or characterize diseases or conditions.
No
The device description explicitly states it is an "Implant System" made from titanium and describes surface treatment, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to support dental restorations in the mouth (mandibles and maxillae). This is a medical device used in vivo (within the body).
- Device Description: The description details the physical components of the implant system (fixtures made of titanium) and its surface treatment. This aligns with a medical device, not a diagnostic test performed in vitro (outside the body).
- 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 CSM Internal -R Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
Product codes
DZE
Device Description
The CSM Internal-R Implant System is intended for use in partial or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The CSM Internal-R Implant system contains two types of fixtures, straight and tapered type based on the shape of the fixture. This system is made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with Resorbable hydroxyapatite Blast Medium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
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)
Non-Clinical Test Data: mechanical testing of the implants demonstrated that the CSM Internal-R Implant System possess mechanical strength at least equivalent to the predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) Summary
Submitter
CSM Implant Cho Sung Am B205 Techno-Building, Kyoungpook National Univ. #573-13, Bokhyun-dong, Buk-Gu, Daegu, Korea Phone: 82-53-952-8261 Fax: 82-53-954-8261
Official Correspondent
Kodent Inc. April Lee 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade Name: CSM Internal-R Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 12/28/2011
Device Description
The CSM Internal-R Implant System is intended for use in partial or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The CSM Internal-R Implant system contains two types of fixtures, straight and tapered type based on the shape of the fixture. This system is made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with Resorbable hydroxyapatite Blast Medium.
Indication for Use
The CSM Internal -R Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading. .
1
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate device:
- SQ IT System manufactured by Neobiotech Co., Ltd. (K090527) .
- Atlas Implant System manufactured by CowellMedi Co., Ltd. (K071148) .
Testing and other comparisons have established that the subject of CSM Internal-R Implant System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.
Comparison Chart
| Subject Device | Predicate Device | Predicate Device | ||
|---|---|---|---|---|
| 510(K) Number | N/A | K090527 | K071148 | |
| Device Name | CSM Internal-R | |||
| Implant System | SQ IT System | Atlas Implant | ||
| System | ||||
| Manufacturer | CSM Implant | Neobiotech Co., Ltd. | CowellMedi Co., | |
| Ltd. | ||||
| Indications for Use | Mandible and | |||
| Maxilla Endosseous | ||||
| Dental Implant & | ||||
| Accessories | Mandible and | |||
| Maxilla Endosseous | ||||
| Dental Implant & | ||||
| Accessories | Mandible and | |||
| Maxilla Endosseous | ||||
| Dental Implant & | ||||
| Accessories | ||||
| Design | Internal Design with | |||
| straight and tapered | Internal tapered | |||
| design | Internal, external, | |||
| submerged with | ||||
| straight and design | ||||
| Implant Sterile | Yes | Yes | Yes | |
| Sterilization Method | Gamma | Gamma | Gamma | |
| Abutment and cover screw | ||||
| sterilization method | Non-sterile | Non-sterile | Non-sterile | |
| Surface Treatment | RBM | |||
| (Resorbable Blasting | ||||
| Media) | RBM | |||
| (Resorbable Blasting | ||||
| Media) | RBM | |||
| (Resorbable Blasting | ||||
| Media) | ||||
| Implant Diameters | 3.5 - 4.8 mm | 3.5 - 6.0 mm | 3.5 - 5.0 mm | |
| Implant Lengths | 8 - 14 mm | 8 - 15 mm | 8 - 14 mm | |
| Abutment | Diameters | 3.5 - 5.5mm | 3.5 - 6.0mm | 3.5 - 6.0mm |
| Lengths | 4.0 - 8.0mm | 4.0 - 8.5mm | 4.0 - 8.5mm | |
| Angulations (Angled | ||||
| Abutment) | 15°, 25° | 15°, 25° | 15°, 25° | |
| Attachments | Various abutments | |||
| and components | Various abutments | |||
| and components | Various abutments | |||
| and components | ||||
| Implant material | Ti-6Al-4V ELI | |||
| ASTM-F136 | Ti-6Al-4V ELI | |||
| ASTM-F136 | Ti-6Al-4V ELI | |||
| ASTM-F136 | ||||
| Cover Screw | ||||
| Material | CP. Ti. Gr. 4 | |||
| ASTM-F67 | CP. Ti. Gr. 4 | |||
| ASTM-F67 | CP. Ti. Gr. 4 | |||
| ASTM-F67 | ||||
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA |
2
Substantial equivalence chart summary
The CSM Internal-R Implant System has a substantially equivalent intended use as the identified predicates, SQ IT System (K090527) manufactured by Neobiotech Co., Ltd. and Atlas Implant system (K071148) by Cowellmedi Co., Ltd. These systems are made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The 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. CSM Internal-R Implant System and predicate device are made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with RBM.
These predicate devices and CSM Internal-R Implant System have been designed, manufactured and tested in compliance with FDA 's Class II special controls guidance document rootform endosseous dental implants and endosseous dental implant abutment. The subject and predicate devices are similar in size, surface treatment, and both are sterilized via gamma irradiation. When compared with predicate devices, no new questions of safety or effectiveness have been raised for the CSM Internal-R Implant System.
Non-Clinical Test Data
All of the data consistent with the recommendations in the FDA guidance document Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the CSM Internal-R Implant System possess mechanical strength at least equivalent to the predicate devices.
Among the information and data presented in this 510(k) submission to support the substantial equivalence of the CSM Internal-R Implant System to the specified predicate devices, fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the CSM Internal-R Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use.
Safety and Effectiveness
CSM Internal-R Implant System is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The CSM Internal-R Implant System, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.
3
Conclusion
The CSM Internal-R Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, CSM Internal-R Implant System and its predicate devices are believed to be substantially equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 7 2012
CSM Implant C/O Ms. April Lee Official Correspondent Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821
Re: K120043
Trade/Device Name: CSM Internal-R Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 20, 2012 Received: April 25, 2012
Dear Ms. Lee:
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.
5
Page 2 - Ms. Lee
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,
Susan Runoer
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
6
Indication for Use
510(K) Number (if known):
KIJO043
Device Name: CSM Internal-R Implant System
The CSM Internal-R Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or over denture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
Prescription Use X The-Counter
AND/OR
Over-
(Per
(Part 21 CFR 801 Subpart D) 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Soun
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital Page 1 of 1
Infection Control, Dental Devices
510(k) Number: K120043