(51 days)
Not Found
No
The 510(k) summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a dental implant system indicated for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations, replacing missing teeth. This aligns with the definition of a therapeutic device designed to treat or alleviate a condition (tooth loss) by restoring function and structure.
No
The device is described as a dental implant system used for replacing missing teeth, not for diagnosing medical conditions. Its intended use is surgical placement and support for restorations.
No
The device description explicitly states it is a "dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Hero II and UI Dental Implant Systems are surgically placed in the bone of the jaw. Their purpose is to support dental restorations, replacing missing teeth. This is a surgical and prosthetic device, not a diagnostic test performed on a sample outside the body.
The information provided focuses on the physical characteristics, surgical placement, and intended function of the implants within the patient's body, which are characteristics of a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Hero II Dental Implant System and the UI Dental Implant System are 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 Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after 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 R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.
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 was conducted on the unmodified device and reviewed in the previous 510K submission (K121047). These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards.
- Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment
- Shelf life testing
- Sterilization validation
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
510(k) Summary (K130221)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 03/08/2013
l. Submitter
| Submitter | |
|---|---|
| Name | |
| Address | MEDIMECCA Co., Ltd. |
| Daeryung Techno Twon 3-cha 104~105, 448, Gasan- | |
| dong, Guemcheon-gu, Seoul, 153-772 Rep, of Korea | |
| Phone | |
| Fax | |
| Contact | Tel : +82-2-856-8282 |
| Fax : +82-2-856-0238 | |
| Woo-Young Ha |
- U.S Agent/Contact Person
LK Consulting Group USA, Inc. 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Fax: 714-409-3357 Phone: 714.869.3080 Email: juhee.c@lkconsultinggroup.com
-
- Device
Trade Name: Hero II Dental Implant System. UI Dental Implant System Common Name: Dental Implant Classification Name: Endosseous Dental Implant System Product Code: DZE, NHA Classification regulation: 21CFR872.3640
- Device
Predicate Device: 4.
HERO II and IS Dental Implant System (K121047) Osseofuse implant system (K110577)
510(k) Submission.
1
-
Purpose of Submission 5.
The purpose of this Special 510(k) is to add a new design fixture model to the unmodified device (HERO II and IS Dental Implant System (K121047) and to change the name of IS Dental Implant System to UI Dental Implant System. The intended use and the principal technology of the subject device are the unmodified device. -
Description: 6.
The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after 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 R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. The size information is as below.
Hero-II Fixture
Ø 3.75mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 4.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm 0 4.50mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 5.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 6.00mm x (L) 8.5mm, 10.0mm, 11.5mm,13.0mm, & 15mm
UI Fixture
Ø 3.5(Thread diameter) x (L) 8.5mm, 10.0mm, 11.5mm, & 13.0mm Ø 4.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm . Ø 4.5 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm 0 5.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm 0 6.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm
Abutments
Diameter Ø4mm ~ Ø7mm Cuff height 14mm Height 47mm
-
- Indication for use:
The Hero II Dental Implant System and the UI Dental Implant System are 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 Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for
- Indication for use:
510(k) Submission.
2
delayed loading.
Non-clinical testing 8.
The following nonclinical tests were conducted on the unmodified device and reviewed in the previous 510K submission (K121047). These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards.
- Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment
-
Shelf life testing
-
Sterilization validation
- Basis for Substantial Equivalence
The Hero II Dental Implant System and the UI Dental Implant System have the same intended use as the identified predicate device (K121047). The Hero II / UI Dental Implant system and the unmodified devices are the same in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium. They all share same internal hexagon abutment connection system with internal beveled interface. The subject and the unmodified devices are both bone-level implants that share similar body shape design such as straight walled neck and tapered body design.
The difference is the minor thread design on the fixture.
- Conclusion
The subject devices and the predicate devices have the same intended use and have the same technological characteristics. The subject and the predicate implants are all made of commercially pure titanium and have the same surface treatments.
Overall, the Hero II Dental Implant System and the UI Dental Implant System have the following similarities to the predicate devices:
-
- have the same intended use,
-
- use the same operating principle,
-
- incorporate the same basic design,
-
- incorporate the same material.
Based on the similarities, we conclude that the Hero II Dental Implant System and the Ul Dental Implant System are substantially equivalent to the predicate devices.
510(k) Submission.
3
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Medimecca Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Incorporated 951 Starbuck Street, Unit J Fullerton CA 92833
Re: K130221
Trade/Device Name: Hero II Dental Implant System UI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 14, 2013 Received: February 20, 2013
Dear Ms. Chung:
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. Isting 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.
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
4
Page 2 - Ms. Chung
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.
Kwame O.Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K13022 510(k) Number (if known):
Hero II Dental Implant System Device Name: UI Dental Implant System
Indications For Use:
The Hero II Dental Implant System and the UI Dental Implant System are 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 Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Prescription Use 1 (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
2013.03.14 07:42:14 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
K130221 510(k) Number: