(118 days)
K113554
No
The summary describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being intended to "restore the patient's chewing function" and for "functional and esthetic oral rehabilitation," which are therapeutic goals aimed at treating a patient's condition (edentulism/missing teeth).
No
The device, a dental implant, is intended for therapeutic purposes (providing support for prosthetic devices and restoring chewing function) rather than for diagnosing a condition or disease.
No
The device description clearly states it is a dental implant made of titanium, which is a physical hardware component. The intended use also describes a surgical procedure involving placement of this physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided description clearly states that this device is a dental implant intended to be surgically placed in the bone of the jaw. It is a physical implant used to support prosthetics and restore chewing function.
- Intended Use: The intended use is for surgical implantation and functional restoration, not for testing biological samples.
The device described is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The CMI Implant IS II active 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. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE
Device Description
Neo CMI Implant IS II active system is dental implant consist of pure titanium, grade 4. The titanium implant surface was sandblasted with large grits and acid etched (S.L.A.) This implant system can be used for all oral endosteal implant indications in the mandible and maxilla, for functional and esthetic oral rehabilitation of edentulous. The fixture diameters are 3.8, 4.3, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 and the lengths are 7.3, 8.5, 10.0, 11.5, 13.0, and 15.0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches, mandible and maxilla
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)
Static Compressive Load Test Data was provided to identify substantial equivalence of modifications from the predicate device.
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:
Hee Seok Jung neobiotech Co., Ltd. e-space #103, 104-1, 104-2, 105, 106, 205, 212, 312, 509,511,10 floor, Guro-dong, Guro-gu, Seoul, Korea 152-789 Phone: 82-53-857-5770 82-53-857-5432 Fax:
Contact /US agent:
April Lee Kodent, Inc. 325 N. Puente St. Unit B Brea, CA 92821
Phone: 714-525-0114 Fax: 714-525-0116
Device Information:
Device Name: CMI Implant IS II active Classification Name: Implant, Endosseous, Root-Form Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date prepared: 5/21/2012
Device Description
Neo CMI Implant IS II active system is dental implant consist of pure titanium, grade 4. The titanium implant surface was sandblasted with large grits and acid etched (S.L.A.) This implant system can be used for all oral endosteal implant indications in the mandible and maxilla, for functional and esthetic oral rehabilitation of edentulous. The fixture diameters are 3.8, 4.3, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 and the lengths are 7.3, 8.5, 10.0, 11.5, 13.0, and 15.0.
Indications for use
The CMI Implant IS II active 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. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
K120503
JUN 1 8 2012
1
Non Clinical Study Data
Static Compressive Load Test Data was provided to identify substantial equivalence of modifications from the predicate device.
Predicate devices
CMI Implant IS System (K113554) manufactured by neobiotech Co., Ltd.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Product Name | CMI Implant IS II active | CMI Implant IS System | |
| 510(k) | N/A | K113554 | |
| Manufacturer | neobiotech Co., Ltd. | neobiotech Co., Ltd. | |
| Shape | Image: [CMI Implant IS II active shape] | Image: [CMI Implant IS System shape] | |
| Intended use | Identical to the predicate | 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. | |||
| Composition of | |||
| Material | Titanium Grade 4 of ASTM F | ||
| 67 | Titanium Grade 4 of ASTM F | ||
| 67 | |||
| Device | |||
| design | Dia(Ø) | Identical to the predicate | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 |
| Length(mm) | Identical to the predicate | 7.0/7.3/8.5/10.0/11.5/13.0/15.0 | |
| Surface treatment | S.L.A | RBM | |
| Biocompatibility | Yes | Yes | |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
2
Summary of Substantial Equivalence Comparison
The CMI Implant IS II active is the same device characteristics as the predicate device, CMI Implant IS System; intended use, material, design and use concept are similar. Based on the comparison of intended use and technical features, CMI Implant IS II active is substantially equivalent to the predicate device.
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 neobiotech Co., Ltd. concludes that the CMI Implant IS II active is substantially equivalent to predicate device as described herein.
3
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUN 18 2012
Kodent, Incorporated C/O Ms. April Lee Consultant Neobiotech Company Limited 325 North Puente Street, Unit B Brea, California 92821
Re: K120503
Trade/Device Name: CMI Implant IS II Active Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 21, 2012 Received: May 24, 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.
4
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.
Ph 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
5
Indication for Use
510(K) Number (if known): KIBO503
Device Name: CMI Implant IS II active
Indications for Use:
The CMI Implant IS II active 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. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Prescription Use AND/OR · Use (Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
OverThe-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Sven
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devi
510(k) Number: