(178 days)
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No
The document describes a standard dental implant system and does not mention any AI or ML components or functionalities.
No
The device is a dental implant system used for replacing missing teeth, which falls under restorative dentistry rather than therapeutic treatment.
No
This device is a dental implant system used to replace missing teeth, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a dental implant system made of titanium, which is a hardware component.
Based on the provided information, 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 and Intended Use: The UD Implant System is a dental implant system designed to be surgically placed in the bone of the jaw to support dental restorations. It is a physical implant used in vivo (within the body), not a device used to test samples in vitro (outside the body).
The description clearly indicates a surgical implant for structural support within the mouth, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Per the Indications for Use (page 6): UD Implant System is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage surgical procedures. This system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone of the upper or lower jaw arches, partially or fully edentulous mandibles and maxilla
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing was conducted to validate its safety.
- Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
- Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
- Mechanical properties test including adaptation accuracy test (Implant to abutment comparibility). 35° compressive loads test, torsional breaking force test, removal torque force test. and fatigue test
- Sterilization validation and shelf life tests
- The biocompatibility tests have been performed in accordance with ISO10993 series.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
This summary of 510(K) – safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 12/04/2013
1. Applicant / Submitter
MEDIMECCA Co., Ltd. Daeryung Techno Twon 3-cha 104~105. 448, Gasan-dong, Guemcheon-gu, Scoul, 153-772 Rep. of Korea
Tel : +82-2-856-8282 Fax : +82-2-856-0238 Contact: Woo-young Ha
2. U.S Agent/Submission Correspondent
DEC 0 5 2013
LK Consulting Group USA, Inc. 1515 E Katella Ave. Unit 2115, Anaheim, CA 92805 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
| Proprietary/Trade Name | UD Implant System |
|---|---|
| Common/Usual Name | Dental Implant |
| Classification Name | Endosseous Dental Implant |
| Classification Product Code | DZE, NHA |
| Classification regulation | 21CFR872.3640 |
| Class | II |
4. Predicate Device:
Hero II and IS Dental Implant System by KJ Meditech Co., Ltd. (K121047)
5. Description:
UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.
1
6. Model List
(1) Fixture
Diameter : 0 3.75mm, 0 4.0mm, 0 4.5mm, 0 5.0mm, 0 6.0mm Length : 7.3mm, 8.5mm, 10.0mm, 11.5mm, 13mm
*7.3mm length is not available for the 3.75 diameter implant fixtures.
(2) Abutments
| No | Component | Description |
|---|---|---|
| 1 | Cover Screw | Type |
| Internal | ||
| Size(Diameter) | ||
| 2.8mm, 3.37mm | ||
| 2 | Healing Abutment | Type |
| Internal | ||
| Size(Diameter) | ||
| 4.0mm, 4.5mm, 5.5mm, 6.5mm | ||
| 3 | Dual Abutment | Type |
| Internal Hex, Internal Non-Hex | ||
| Size(Diameter) | ||
| 4.0mm, 4.5mm, 5.5mm, 6.5mm | ||
| 4 | Combi Abutment | Type |
| Internal | ||
| Size(Diameter) | ||
| 4.0mm, 4.5mm, 5.5mm, 6.5mm | ||
| 5 | Angled Abutment | Type |
| Internal Hex, Internal Non-Hex | ||
| Angle: 15°, 25° | ||
| Size(Diameter) | ||
| 4.5mm, 5.5mm | ||
| 6 | Milling Abutment | Type |
| Internal Hex, Internal Non-Hex | ||
| Size(Diameter) | ||
| 4.0mm, 4.5mm, 5.5mm, 6.5mm | ||
| 7 | Temporary Abutment | Type |
| Internal Hex, Internal Non-Hex | ||
| Size(Diameter) | ||
| 4.0mm, 4.5mm | ||
| 8 | Ball Abutment | Type |
| Internal Hex, Internal Non-Hex | ||
| Size(Diameter) | ||
| 3.5mm |
7. Indication for use:
UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
8. Basis for Substantial Equivalence
The UD Implant System is substantially equivalent to previously marketed devices. The design features and sizing of the components were compared and the UD Implant System found to be substantially the same as the predicate device. It is indicated for the same intended use. There are no significant differences between the UD Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to other devices in design, function, material and intended use.
2
| Device Name | UD Implant System | HERO II Dental Implant System
IS Dental Implant System |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) no | - | K121047 |
| Applicant | MEDIMECCA CO LTD | KJ Meditech Company, Limited. |
| Classification | Endosseous dental implant
(Class 11, 21CFR872.3640) | Endosseous dental implant
(Class 11, 21CFR872.3640) |
| Material | Titanium
(ASTM F136, ASTM F67 Gr 4) | Titanium 6Al 4V ELI Alloy |
| Surgery Type | One stage, Two stages | One stage, Two stages |
| Structure | Internal Hexagon connection
Self-taping cutting edge threads | Internal Hexagon connection
Self-taping cutting edge threads |
| Dimension | Fixture:
Diameter :
Ø 3.75mm, Ø 4.0mm, Ø 4.5mm,
Ø 5.0mm. Ø 6.0mm
Length :
7.3mm, 8.5mm, 10.0mm, 11.5mm,
13mm
Abutment
Diameter : Ø 46.5mm | Fixture:7mm |
Diameter :
Ø 3.75mm, Ø 4.0mm. Ø 4.5mm.
Ø 5.0mm. Ø 6.0mm
Length :
7.3mm, 8.5mm, 10.0mm, 11.5mm,
13mm
Abutment
Diameter : Ø 4
| Surface(Fixture) | R.B.M. | R.B.M. |
| Intended use | intended for use in partially or fully
edentulous mandibles and maxilla,
in support of single of multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework. UD
Implant System is for single stage
and two stage surgical procedures.
This system is intended for delayed
loading. | intended for use in partially or fully
edentulous mandibles and maxilla,
in support of single of multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework.
HERO II Dental Implant System
and IS Dental Implant System is for
single stage and two stage surgical
procedures. This system is intended
for delayed loading. |
| Sterilization | Gamma radiation | Gamma radiation |
| Shelf-life | 5 years | 5 years |
9. Non-clinical Testing
The following non-clinical testing was conducted to validate its safety.
- Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
- Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
- Mechanical properties test including adaptation accuracy test (Implant to abutment comparibility). 35° compressive loads test, torsional breaking force test, removal torque force test. and fatigue test
- Sterilization validation and shelf life tests
- The biocompatibility tests have been performed in accordance with ISO10993 series.
3
10. Conclusion
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the titanium alloys and have the same surface treatments. The subject and the predicate devices encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter of the abutments.
Overall, the UD Implant System has the following similarities to the predicate device: * has the same intended use.
-
- uses the same operating principle.
-
- incorporates the same basic design.
-
- incorporates the same material and the surface treatment.
Based on the similarities, we conclude that the UD Implant System is substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring MD 20993-00002
December 5, 2013
MEDIMECCA Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Incorporated 1515 East Katella Avenue, Unit 2115 Anaheim, CA 92805
Re: K131682
Trade/Device Name: UD Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 4, 2013 Received: November 7, 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, 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
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 -S for
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
Enclosure
6
Indications for Use
510(k) Number (if known) K131682
Device Name
UD Dental Implant System
Indications for Use (Describe)
UD Implant System is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage surgical procedures. This system is intended for delayed loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/6/Picture/13 description: The image shows the name "Susan Runner DDS, MA" in a stylized font. Next to the name is "Mary S. Runner -S". Below this is the date and time "2013.12.05 08:45:15 -05'00'".
FORM FDA 3881 (9/13)
in Services (301) 443-67-67-0