(258 days)
Not Found
No
The summary describes a standard dental implant system made of titanium and other materials, with no mention of software, algorithms, or any terms related to AI or ML. The performance studies are based on non-clinical testing according to FDA guidance for dental implants, not on the performance of an AI/ML algorithm.
Yes
The device is a dental implant system used to replace missing teeth and support restorations, which directly contributes to the treatment and restoration of oral function.
No
The device is a dental implant system used for supporting restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a dental implant system made of Titanium-6A1-4V ELI alloy and includes various physical components like implants, abutments, and accessories. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the bone of the jaw to support dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the physical components of a dental implant system (implants, abutments, accessories) and their materials. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a surgically implanted medical device used for structural support in dental procedures.
N/A
Intended Use / Indications for Use
The U fit Dental 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. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The U fit Implant System is a dental implant system made of Titanium-6A1-4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for lading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with RBM (Resorbable Blasted Media). The Fixture diameters are 3.8, 3.9, 4.0, 4.1, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm and lengths are 7. 8.5, 10. 11.5, 13, 14.5 mm in this system. The contained various abutments and accessories in the system are cover screw, abutment screw, healing abutment, solid abutment, transfer abutment, milling abutment, Temporary Abutment, protect cap, solid impression coping, solid lab analog, impression coping/pick-up, impression coping/transfer, and fixture lab analog. The material of abutments and accessories are Ti-6A1-4V ELI(ASTM F-136), POM-C and stainless steel. The abutment diameters are 4.0, 4.1, 4.4, 4.5, 4.8, 5.0, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3, 7.8 and Heights are 4.0, 5.5, 7.0, 9.0. The implants are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
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)
Non-clinical testing consisted of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the U fit Dental Implant System is substantially equivalent to the predicate devices.
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.
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K132956
510(k) Submission - U fit Dental Implant System
T Strong, Inc.
510(K) Summary
Submitter
T Strong, Inc. Han Chang Woo 181-4 Uijeon-ri, Jinyeong-eup, Gimhae-si. Gyeongnam 621-801, Republic of Korea Phone: +82-55-342-1771 Fax: +82-55-342-1775
Official Correspondent Kodent, Inc. Susan Park 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-01116
Date prepared: 9/17/2013
Device Information
Trade Name: U fit Dental Implant System Common Name: Endosseous dental implant Classification Name: Implant, Endosseous, Root-Form Product code: DZE Subsequent Product Code: NHA Device Class: Class II Regulation number: 21 CFR 872.3640
General Description
The U fit Implant System is a dental implant system made of Titanium-6A1-4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for lading affer a conventional healing period.
The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with RBM (Resorbable Blasted Media).
The Fixture diameters are 3.8, 3.9, 4.0, 4.1, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm and lengths are 7. 8.5, 10. 11.5, 13, 14.5 mm in this system.
The contained various abutments and accessories in the system are cover screw, abutment screw, healing abutment, solid abutment, transfer abutment, milling abutment, Temporary Abutment, protect cap, solid impression coping, solid lab analog, impression coping/pick-up, impression coping/transfer, and fixture lab analog.
The material of abutments and accessories are Ti-6A1-4V ELI(ASTM F-136), POM-C and stainless steel. The abutment diameters are 4.0, 4.1, 4.4, 4.5, 4.8, 5.0, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3, 7.8 and Heights are 4.0, 5.5, 7.0, 9.0.
The implants are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.
Indications for Use
The U fit Dental 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
JUN 0 5 2014
1
bridgework. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Predicate Device Information
The subject device is substantially equivalent to the following predicate device:
- . US/SS/GS System manufactured by OSSETEM Co., Ltd. (K073247)
- . Implantium Abutment manufactured by Dentium Co., Ltd. (K052823)
Comparison Chart
1) Fixtures
| Subject device | Predicate device | ||
|---|---|---|---|
| Device name | U fit Dental Implant System | US/SS/GS System | |
| 510(k) number | NA | K073247 | |
| Manufacturer | T Strong, Inc. | OSSETEM Co., Ltd. | |
| Intended use | Identical to the predicate | The US/SS/GS 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. The U fit | |||
| Dental Implant System is for single and | |||
| two stage surgical procedures. It is | |||
| intended for delayed loading. | |||
| Material | Ti-6Al-4V ELI | ||
| ASTM F136 | Ti-6Al-4V ELI | ||
| ASTM F136 | |||
| Design | Image: Four dental implants | Image: One dental implant | |
| Fixture Type | Submerged | Submerged | |
| Implant diameter | 3.8, 3.9, 4.0, 4.1, 4.5, | ||
| 5.0, 5.5, 6.0, 6.5, 7.0 mm | 3.3 - 6.0 mm | ||
| Implant length | 7, 8.5, 10, 11.5, 13, 14.5 mm | 7 - 18 mm | |
| Components | Various abutments and accessories | Various abutments and components | |
| Surface treatment | RBM | RBM | |
| Gamma sterilized | Yes | Yes | |
| Product Code | DZE | DZE |
2
510(k) Submission - U fit Dental Implant System
T Strong, Inc.
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2) Abutments
,所
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | U fit Dental Implant System | IMPLANTIUM ABUTMENTS |
| 510k # | NA | K052823 |
| Manufacturer | T Strong, Inc. | Dentium, Inc. |
| Product Code | NHA | NHA |
| Cover Screw | ||
| Design | ||
| Intended Use | To provide sealing effect for fixture | To provide sealing effect for fixture |
| Material | Ti-6Al-4V ELI Gr.23 | Ti-6Al-4V ELI Gr.23 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
| Abutment Screw | ||
| Design | ||
| Intended Use | To connect abutment to fixture | To connect the abutment to the fixture |
| Material | Ti-6Al-4V ELI, ASTM F136 | Ti-6Al-4V ELI, ASTM F136 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
| Healing Abutment | ||
| Design | ||
| Intended Use | To help the soft tissue of gum naturally | |
| formed | To help the soft tissue of gum naturally | |
| formed | ||
| Material | Ti-6Al-4V ELI Gr.23 | Ti-6Al-4V Eli, Gr. 23 |
| Sterilization | Steam Sterilization by user | Gamma Sterilization |
| Solid Abutment | ||
| Design | ||
| Intended Use | Cement retained restoration | Cement retained restoration |
| Material | Ti-6Al-4V ELI Gr.23 | CP Ti Gr.4 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
| Transfer Abutment | ||
| Design | Image: Transfer Abutment Design 1 | Image: Transfer Abutment Design 2 |
| Intended Use | Cement retained restoration | Cement retained restoration |
| Material | Ti-6Al-4V ELI Gr.23 | CP Ti Gr.4 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
| Milling Abutment | ||
| Design | Image: Milling Abutment Design 1 | Image: Milling Abutment Design 2 |
| Intended Use | Cement retained restoration | Cement retained restoration |
| Material | Ti-6Al-4V ELI Gr.23 | CP Ti Gr3. ASTM F67 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
| Temporary Abutment | ||
| Design | Image: Temporary Abutment Design 1 | Image: Temporary Abutment Design 2 |
| Intended Use | To manufacture temporary prostheses | To manufacture temporary prostheses |
| Material | Ti-6Al-4V ELI Gr.23 | CP Ti Gr.4 |
| Sterilization | Steam Sterilization by user | Steam Sterilization by user |
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Comparison Analysis
The U fit Dental Implant System has a substantially equivalent intended use as the identified predicate. The U fit Dental Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium.
The U fit Dental Implant System is substantially equivalent in materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.
The only differences between the subject device and the predicate are slight differences in fixture designs and diameters.
Any differences in technology characteristics are accompanied by information that demonstrated the device is safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.
4
Non-Clinical Data
The manufacturing and development process for the U fit Dental Implant System is compliance with ISO 13485(Medical devices - Quality management systems - Requirements for regulatory purposes), ISO 14971(Medical devices - Application of risk management to medical devices), ISO 10993-1(Biological evaluation of medical devices), EN 980(Symbols for use in the labelling of medical devices), EN 1041(Information supplied by manufacturer of medical devices). Biocompatibility testing has been performed in accordance with ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO10993-10, ISO 10993-11, ASTM F67, ASTM F750-87, USP, USP, ISO 7405. Sterilization validating testing has been performed in accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization. Analysis of chemical and SEM images have been performed to verify that there is no residual after RBM treatment on the Fixture. Non-clinical testing consisted of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the U fit Dental Implant System is substantially equivalent to the predicate devices.
Conclusion
The U fit Dental Implant System constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than other implant system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, U fit Dental Implant System and its predicate devices are substantially equivalent.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 5, 2014
T Strong, Incorporated C/O Ms. Susan Park Kodent, Incorporated 325 N. Puente Street, Unit B Brea, California 92821
Re: K132956
Trade/Device Name: U Fit Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 24, 2014 Received: April 24, 2014
Dear Ms. Park:
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 - Ms. Park
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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/ReportalProblem/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 Industry and Consumer Education 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,
Mary S: Runner -S
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
and the commend of the comments of the country of
Enclosure
7
Indication for Use
K132956 510(K) Number (if known):
Device Name: U fit Dental Implant System
The U fit Dental 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. The U fit Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (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) Page 1 of 1
Sheena A. Green -S 2014.06.05 07:48:23-04'00