(126 days)
No
The document describes a standard dental implant system made of titanium and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device, a dental implant system, is intended to support dental restorations and is surgically placed, which is not a therapeutic function but rather a restorative or prosthetic one.
No
The device is a dental implant system used for supporting dental restorations in edentulous mandibles and maxillae, not for diagnosing medical conditions.
No
The device description explicitly states it is a "dental implant system made of titanium Grade s of ASTM F 67 intended to be surgically placed in the bone," indicating it is a physical hardware device.
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.
- Device Description: The CMI Implant IS System is a dental implant system surgically placed in the bone of the jaw. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use describes supporting dental restorations in the mouth, not analyzing biological specimens.
The information provided clearly indicates this is a surgically implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CMI Implant IS 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. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5 mm are indicated for molar regions.
Product codes
DZE, NHA
Device Description
The CMI Implant IS System is a dental implant system made of titanium Grade s of ASTM F 67 intended to be surgically placed in the bone of the upper or lower jaw arches. The CMI Implant IS System is composed of submerged fixtures with straight & angled abutments. To cover all case of surgery, each component of dental implant set has various size and dimension.
-
Fixture
It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are two types of Fixtures, Submerged implant design and non-micro thread design.
The diameters of submerged implant design fixtures are 3.5/4.0/5.0/6.0/7.0/8.0mm and the lengths are 7.0/8.5/10.0/11.5/13.0/15.0 mm. The diameters of Non-Micro thread design fixtures are 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0mm and the lengths are 7.0/7.3/8.5/10.0/11.5/13.0/15.0mm. -
Cover Screw, Healing Abutment
It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge during osseointegration.
It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge for term of making upper prostheses and establishing proper emergence profile after osseointegration. -
Abutment
It is intermediate component placed between the implant (fixture) and restoration (Crown, gold or ceramic) providing support. D Device is made of gold alloy or unalloyed titanium which can be used coated with TiN or non-coated state. There are Cemented(Hex/non-Hex), Angled, SCRP, Solid, UCLA Gold/Plastic, Ball, and Temporary Abutment in this system.
The system is similar to the commercially available product based on the intended use, the technology used, the material composition employed and performance characteristics. IS System is made from pure titanium and the surface treatment is done with R.B.M.
*The purpose of the device modification to purpose the variety of products for users' preference
- . Addition of Implant Fixture (non-micro thread type)
- . Addition of the number of models according to the addition of sizes of Two IS Fixtures, Cover Screw, Healing Cap, Solid Abutment, Protective Cap, Cemented abutment, Cemented SCRP Abutment, Cemented non-Hex Abutment- Non Sterilized, UCLA Abutment, Ball Abutment, Temporary Abutment, and Combination Screw.
- . Shelf-Life change : 3years -> Syeaes
Materials
This device is manufactured from Ti G4 and Ti-6A1-4V ELI alloy following ASTM and ISO standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous 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)
Fatigue testing was performed in accordance with ISO 14801 standard and risk analysis was performed in accordance with ISO 14971 standard.
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
APR - 5 2012
510(k) Summary
Submitter:
Hee Seok Jeong neobiotech Co., Ltd. e-space #103, 104-1, 104-2, 105, 106, 205, 212, 312 509,511/10th floor, Guro-dong, Guro-gu, Seoul, Korea 152-789
Phone: 82-2-582-2885 Fax: 82-2-582-2883 Date of Submission: 10/7/2011 Contact /US agent: April Lee KoDent, Inc. 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: CMI Implant IS System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE, NHA Regulation Number: 21 CFR 872.3640 Date prepared: 4/3/2012
General Description
The CMI Implant IS System is a dental implant system made of titanium Grade s of ASTM F 67 intended to be surgically placed in the bone of the upper or lower jaw arches. The CMI Implant IS System is composed of submerged fixtures with straight & angled abutments. To cover all case of surgery, each component of dental implant set has various size and dimension.
1. Fixture
It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are two types of Fixtures, Submerged implant design and non-micro thread design.
The diameters of submerged implant design fixtures are 3.5/4.0/5.0/6.0/7.0/8.0mm and the lengths are 7.0/8.5/10.0/11.5/13.0/15.0 mm. The diameters of Non-Micro thread design fixtures are 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0mm and the lengths are 7.0/7.3/8.5/10.0/11.5/13.0/15.0mm.
- Cover Screw, Healing Abutment
: It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge during osseointegration.
1
: It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge for term of making upper prostheses and establishing proper emergence profile after osseointegration.
3. Abutment
It is intermediate component placed between the implant (fixture) and restoration (Crown, gold or ceramic) providing support. D Device is made of gold alloy or unalloyed titanium which can be used coated with TiN or non-coated state. There are Cemented(Hex/non-Hex), Angled, SCRP, Solid, UCLA Gold/Plastic, Ball, and Temporary Abutment in this system.
The system is similar to the commercially available product based on the intended use, the technology used, the material composition employed and performance characteristics. IS System is made from pure titanium and the surface treatment is done with R.B.M.
Indication for use
The CMI Implant IS 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. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5 mm are indicated for molar regions.
Device Description & Technological Characteristics
*The purpose of the device modification to purpose the variety of products for users' preference
- . Addition of Implant Fixture (non-micro thread type)
- . Addition of the number of models according to the addition of sizes of Two IS Fixtures, Cover Screw, Healing Cap, Solid Abutment, Protective Cap, Cemented abutment, Cemented SCRP Abutment, Cemented non-Hex Abutment- Non Sterilized, UCLA Abutment, Ball Abutment, Temporary Abutment, and Combination Screw.
- . Shelf-Life change : 3years -> Syeaes
Materials
This device is manufactured from Ti G4 and Ti-6A1-4V ELI alloy following ASTM and ISO standards.
2
Non-clinical test data
Fatigue testing was performed in accordance with ISO 14801 standard and risk analysis was performed in accordance with ISO 14971 standard.
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
- CMI Implant IS System (K090825)
Comparison to Predicate Devices:
The CMI Implant System have the same device characteristics as the predicate device, CMI Implant IS System (K090825), intended use, surface treatment, composition of material, general shape, structure and application method design are same. Comparisons have established that the subject device, CMI Implant IS System is substantially equivalent to the cleared Premarket Notification Device, CMI Implant IS System (K090825).
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Product Name | CMI Implant IS System | CMI Implant IS System | |
| 510(k) | N/A | K090825 | |
| Manufacturer | neobiotech Co., Ltd. | neobiotech Co., Ltd. | |
| Design | Submerged Implant design | ||
| non-micro thread design | Submerged Implant design | ||
| 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) | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 | 3.5/4.0/5.0/6.0/7.0/8.0 |
| Device | |||
| design | Length(L) | 7.0/7.3/8.5/10.0/11.5/13.0/15.0 | 7.0/8.5/10.0/11.5/13.0/15.0 |
3
| Surface treatment | RBM | RBM |
|---|---|---|
| Biocompatibility | Yes | Yes |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
Conclusion
. The CMI Implant IS System has the same device characteristics as the predicate device, CMI Implant IS System (K090825). The intended use, surface treatment, composition of material, general shape, structure, and application method design are same.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neobiotech Company, Limited C/O Ms. April Lee Kodent, Incorporated 325 North Puente Street Unit B Brea, California 92821
2012
Re: K113554
Trade/Device Name: CMI Implant IS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 1, 2012 Received: March 7, 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 Eederal 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,
Nh 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
6
Indication for Use
K11355
510(K) Number (if known):
Device Name: CMI Implant IS System
Indication for Use:
The CMI Implant IS 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. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5 mm are indicated for molar regions.
C
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
AND/OR
Prescription Use _ ਮ Over-The-Counter
(Part 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)