(122 days)
No
The device description and performance studies focus on the physical properties, sterilization, and mechanical testing of dental implants and associated components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The UV Active Implant System is intended to restore a patient's chewing function by providing a root form means for prosthetic attachment, which is a restorative function, not a therapeutic one in the medical sense of treating a disease or disorder.
No
This device, the UV Active Implant System, is an implantable medical device designed for surgical placement in the jaw arches to restore chewing function. Its purpose is to provide a physical means for prosthetic attachment, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium and titanium alloy, intended for surgical implantation. This indicates a hardware-based medical device, not software-only.
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 jaw to provide a means for prosthetic attachment to restore chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device components (fixtures, abutments, screws, cylinders) are all physical implants and associated hardware designed for surgical implantation and mechanical support.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or diagnostic purposes.
Therefore, the UV Active Implant System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.
The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.
The Regular (Ø3.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
The Wide (06.0 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).
The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.
The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.
The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches
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 included:
- Sterilization Validation and Shelf Life Testing: Performed in accordance with ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, and ISO 11737-2 for gamma sterilization and ISO 17665-2 for steam sterilization. Results demonstrated SAL of 10-6 was achieved. Accelerated aging shelf life testing according to ASTM F1980 was conducted for sterile devices. Tests included Seal peeling test (ASTM F88), Burst test (ASTM F1140), Dye penetration test (ASTM F1929), Bubble test (ASTM F2096), Sterility test, Appearance, and Dimension Test.
- Fatigue Test: Performed on the subject device in accordance with ISO 14801:2007. The worst case scenario was chosen based on FDA guidance.
- Biocompatibility: Evaluated with accordance to ISO 10993-1, ISO 10993-5, and ISO 10993-12. Cytotoxicity test was conducted.
Key results:
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device. No new issues of biocompatibility are raised for the subject 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.
K173975, K170608, K161987, K062129, K071357, K150199, K161416, K141457, K161689
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2018
DIO Corporation % Peter Kang Business, Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010
Re: K182194
Trade/Device Name: UV Active Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 22, 2018 Received: November 29, 2018
Dear Peter Kang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182194
Device Name UV Active Implant System
Indications for Use (Describe)
The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.
The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.
The Regular (03.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
The Wide (06.0 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink and has a small pink circle above it, resembling a dot over the letter "i". Below the letters, in a smaller font, are the words "Implant Solution".
510(k) Summary
K182194
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
Jiae Park DIO Corporation 66 Centum seo-ro, Haeundae-gu, Busan, Republic of Korea Phone +82-51-745-7836 Fax +82-51-745-7781
Contact / US agent:
Peter Kang DIO USA. 3470 Wilshire Blvd. #620 Los Angeles, CA Phone +1-213-365-2875 +1-213-365-1595 Fax
Device Information:
Trade Name: UV Active Implant System Common Name: Endosseous dental implant Fixture Classification Name: Fixture, Implant, Dental, Endosseous Device Class: Class II Product Code: DZE Secondary product code : NHA Panel: Dental Regulation Number: 21 CFR 872.3640 Date prepared: 12/11/2018
General Description
The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).
The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.
The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.
The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.
Page 1 of 156
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Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" with "DI" in gray and "O" in pink. Above the "O" is a small pink circle. Below the letters is the text "Implant Solution" in gray.
Indication For Use
The UV Active Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function.
The narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.
The Regular (Ø3.8 ~ Ø5.5) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
The Wide (05.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Predicate and Reference Devices
The subject device is substantially equivalent to the following Predicate and Reference Device:
Primary Predicate Device :
DIO UF HSA Internal Sub-merged Implant System(K122519)
Reference Devices :
UF(II) Wide Fixture (K173975) UF(II) Implant System (K170608) UF(II) NarrowImplant System- Fixture,UF(II) NarrowImplant System- Superstructure(K161987) P.004 Implants (K062129) P.004 NC Anatomic abutment(K071357) Neodent Implant System CM Anatomic Abutment(K150199) Nobel Biocare AB(K161416) Dentium Implantium® and SuperLine® Abutment (K141457) OSSTEM Implant System-Abutment (K161689)
5
Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, gray sans-serif font. To the right of the letters, there is a pink circle with a smaller pink circle above and to the right of it, resembling a stylized "O". Below the letters, the words "Implant Solution" are written in a smaller, gray sans-serif font.
Summaries of Technological Characteristics
The subject device is substantially equivalent to they are substantially equivalent in intended use, material and comection interfaces to the implants are identical for each individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:
1) UV Active Fixture
| Subject Device | Primary Predicate Device | Reference Device | |||
|---|---|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UV Active Implant System | DIO UF HSA Internal Sub- | |||
| Merged Implant System | UF(II) Wide Fixture | UF(II) Implant System | UF(II) Narrow Implant | ||
| System | |||||
| 510(K) No. | Not yet assigned | K122519 | K173975 | K170608 | K161987 |
| Classification | |||||
| Name | Endosseous Dental Implant, | ||||
| Fixture | |||||
| (872.3640) | Endosseous Dental Implant, | ||||
| Fixture | |||||
| (872.3640) | Endosseous Dental | ||||
| Implant, Fixture | |||||
| (872.3640) | Endosseous Dental Implant, | ||||
| Fixture | |||||
| (872.3640) | Endosseous Dental Implant, | ||||
| Fixture | |||||
| (872.3640) | |||||
| Product Code | DZE | DZE | DZE | DZE | DZE |
| Class | II | II | II | II | II |
| Material | CP Ti Gr4(ASTM F67) | CP Ti Gr4(ASTM F67) | CP Ti Gr4(ASTM F67) | CP Ti Gr4(ASTM F67) | CP Ti Gr4(ASTM F67) |
| Design | Internal Type and Morse | ||||
| Tapered | Internal Type and Morse | ||||
| Tapered | Internal Type and Morse | ||||
| Tapered | Internal Type and Morse | ||||
| Tapered | Internal Type and Morse | ||||
| Tapered | |||||
| Fixture | |||||
| Diameter(mm) | 3.0~6.4 | 3.8~7.0 | 5.9~6.9 | 3.8~5.5 | 3.0, 3.3 |
Page 3 of 14
6
DIO Corporation Traditional 510(k) Submission
Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
| | Implant Solution
UV Active Implant System | | | | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fixture
Length(mm) | Ø3.0 – L 8.5, 10, 11.5, 13
Ø3.3 – L 8.5, 10, 11.5, 13
Ø3.8 – L 8.5, 10, 11.5, 13
Ø4.0 – L 8.5, 10, 11.5, 13
Ø4.5 – L 7, 8.5, 10, 11.5, 13
Ø5.0 – L 7, 8.5, 10, 11.5, 13
Ø5.5 – L 7, 8.5, 10, 11.5, 13
Ø5.9 – L 7, 8.5, 10, 11.5, 13
Ø6.4 – L 7, 8.5, 10, 11.5, 13 | Ø3.8 – L 7.0, 8.5, 10, 11.5, 13, 15, 16
Ø4.0 – L 7.0, 8.5, 10, 11.5, 13, 15, 16, 18
Ø4.5 – L 7.0, 8.5, 10, 11.5, 13, 15, 16, 18
Ø5.0 – L 7.0, 8.5, 10, 11.5, 13, 15, 16, 18
Ø5.5 – L 7, 8.5, 10, 11.5, 13, 15, 16, 18
Ø6.0 – L 7, 8.5, 10.5, 12.5, 14.5
Ø6.4 – L 7, 8.5, 10.5, 12.5, 14.5
Ø7.0 – L 7, 8.5, 10.5, 12.5, 14.5 | Ø5.9 – L 7, 8.5, 10, 11.5, 13
Ø6.4 – L 7, 8.5, 10, 11.5, 13
Ø6.9 – L 7, 8.5, 10, 11.5, 13 | Ø3.8 – L 8.5, 10, 11.5, 13, 15, 16
Ø4.0 – L 8.5, 10, 11.5, 13, 15, 16
Ø4.5 – L 7.0, 8.5, 10, 11.5, 13, 15, 16
Ø5.0 – L 7.0, 8.5, 10, 11.5, 13, 15, 16
Ø5.5 – L 7, 8.5, 10, 11.5, 13, 15, 16 | Ø3.0 – L 8.5, 10, 11.5, 13, 15
Ø3.3 – L 8.5, 10, 11.5, 13, 15 |
| Fixture
Surface | SLA | SLA | SLA | SLA | SLA |
| Treatment | | | | | |
| Sterile | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Indications For
Use | The UV Active Implant
System is indicated for
surgical placement in the
upper and lower jaw
arches, to provide a root
form means for single or
multiple units' prosthetic
attachment to restore a
patient's chewing
function.
The narrow (Ø3.0, Ø3.3)
implant is limited to the
replacement of maxillary
lateral incisors and
mandibular incisors. It is
intended for delayed
loading.
The Regular (Ø3.8 ~
Ø5.5) implants can be
placed with a
conventional two stage
surgical process with
an option for
transmucosal healing or
they can be placed in a
single stage surgical
process for immediate
loading when good
primary stability is
achieved with
appropriate occlusal | The DIO UF HSA Internal
Sub-Merged Implant
System is indicated for
surgical placement in the
upper and lower jaw arches,
to provide a root form
means for single or multiple
units' prosthetic attachment
to restore a patient's
chewing function. The
smaller (Ø3.8 ~ Ø5.5)
implants can be placed with
a conventional two stage
surgical process with an
option for transmucosal
healing or they can be
placed in a single stage
surgical process for
immediate loading when
good primary stability is
achieved with appropriate
occlusal loading. The larger
(Ø6.0 ~ Ø7.0) implants can
be placed with a
conventional two stage
surgical process with an
option for transmucosal
healing and are indicated for
the molar region with
delayed loading. | The UF(II) Wide Fixture
is indicated for surgical
placement in the upper
and lower jaw arches, to
provide a root form
means for single or
multiple units' prosthetic
attachment to restore a
patient's chewing
function. The larger (
Ø5.9 ~ Ø6.9mm)
implants can be placed
with a conventional two
stage surgical process
with an option for
transmucosal healing and
are indicated for the
molar region with
delayed loading. | The UF(II) Implant System
is indicated for surgical
placement in the upper and
lower jaw arches, to provide
a root form means for single
or multiple units' prosthetic
attachment to restore a
patient's chewing
function. The UF(II)
Implant
System(Ø 3.8 ~ Ø 5.5) can
be placed with a
conventional two stage
surgical process with an
option for transmucosal
healing or they can be
placed in a single stage
surgical process for
immediate loading when
good primary stability is
achieved with appropriate
occlusal loading. | The UF(II) Narrow Implant
System is intended for two-stage surgical procedures in
the following situations and
with the following clinical
protocols:
-The intended use for the
3.0mm, 3.3mm diameter
UF(II) Narrow Implant is
limited to the replacement
of
maxillary lateral incisors
and mandibular incisors.
-Immediate placement in
extraction sites and in
situations with a partially or
completely healed alveolar
ridge.
- It is intended for delayed
loading. |
| | loading.
The Wide ( ${\O}$ 5.9 ~ ${\O}$ 6.4)
implants can be placed with
a conventional two stage
surgical process with an
option for transmucosal
healing and are indicated
for the molar region with
delayed loading. | | | | |
| Substantial
Equivalence
Comparison | UV Active Fixture is substantially equivalent in designs, dimensions, material and technological characteristics with the identified primary predicate
device except for packaging changes, diameter and slightly different in Indications for use. The UV Active Fixture is same 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-food endosseous dental implants and endosseous dental implant abutments. | | | | |
| | The Packaging of the subject device is different from the predicate devices. However, this difference is mitigated by the validation of the packaging for
subject device, verifying that the packaging differences do not affect the safety and efficiency of the device. | | | | |
| | The diameter difference between Subject device and Primary predicate device occurred because the subject device has Narrow size fixture
( ${\O}$ 3.0, ${\O}$ 3.3). It is mitigated by Reference predicate device (K161987). | | | | |
| | The Indication for use is differences between the Subject device and Primary predicate device (K122519). Different of Indication for use
occurred because the subject device has Narrow size fixture ( ${\O}$ 3.0, ${\O}$ 3.3). The difference of Indication for use is mitigated by Reference
predicate device (K161987). The diameter length of 6.9mm is not part of this submission and all of the subject device dimension are included
predicate device diameter range. Thus, the proposed indications do not increase risk nor change the intended use of the device and are found to
be substantially equivalent. | | | | |
| | Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the
predicate and do not raise different questions of safety and effectiveness than the predicate | | | | |
Page 4 of 14
7
DIO Corporation Traditional 510(k) Submission UV Active Implant System
Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, in a smaller font, is the text "Implant Solution".
Page 5 of 14
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Image /page/8/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with the "D" and "I" in gray and the "O" in pink. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.
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Image /page/9/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink and has a small pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
-
- Multi-unit Abutment
| Subject Device | Reference Device | ||||
|---|---|---|---|---|---|
| Applicant | DIO Corporation | Nobel Biocare AB | Dentium | DIO Corporation | |
| Trade Name | UV Active Implant System | Multi-unit Abutment Plus | Dentium Implantium® and | ||
| SuperLine® Abutment | UF(II) Narrow Implant | ||||
| System | |||||
| 510(K) No. | Not yet assigned | K161416 | K141457 | K161987 | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Titanium vanadium alloy | Pure Ti-G4(ASTM F67) | Ti-6Al-4V ELI | |
| (ASTM F136) | |||||
| Design | Straight Multi- | ||||
| unit abutment | |||||
| Image: Straight Multi-unit abutment | Angled Multi- | ||||
| unit abutment | |||||
| Image: Angled Multi-unit abutment | Image: Multi-unit Abutment Plus | Image: Dentium Implantium and SuperLine Abutment | Image: UF(II) Narrow Implant System | ||
| Abutment | |||||
| Diameters | |||||
| (mm) | 4.8 | 4.8 | 4.5~5.5 | 4.0 | |
| Cuff | |||||
| height(mm) | 1.5/2.5/3.5/4.5/5.5 | 1.5/2.5/3.5/4.5 | 1.0~1.5 | 2.5/3.0/4.0/5.0 | |
| Angle(°) | 0/20/30 | 0/17/30 | 15~30 | 20 |
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Image /page/10/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with "DI" in gray and "O" in pink. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.
2) Abutment Screw
| Subject Device | Primary Predicated Device | Reference Device | |
|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | OSSTEM Implant Co., Ltd. |
| Trade Name | UV Active Implant System | DIO UF HSA INTERNAL SUB-MERGED | |
| IMPLANT SYSTEM | OSSTEM Implant System - | ||
| Abutment | |||
| 510(K) No. | Not yet assigned | K122519 | K161689 |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI |
| Design | Image: Subject Device Design | Image: Primary Predicated Device Design | Image: Reference Device Design |
| Diameters | |||
| ( $Ø$ ) | 2.2 | 1.8/2.0 | 2.0/2.05/2.2/2.3/2.5 |
| Lengths (mm) | 6.0 | 8.5/11.5 | 3.35/5.6/7.5/8.35/9.6/10.2 |
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Image /page/11/Picture/1 description: The image shows the logo for DIO Implant Solution. The letters "DIO" are displayed in a bold, sans-serif font, with "DI" in gray and "O" in pink with a small pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font.
| Subject Device | Reference Device | Reference Device | ||||
|---|---|---|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation | |||
| Trade Name | UV Active Implant System | UF(II) Narrow Implant System | UF(II) Implant System | |||
| 510(K) No. | Not yet assigned | K161987 | K170608 | |||
| Material | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | Titanium Grade 4(ASTM F67) | |||
| Hex | Non-Hex | Hex | Non-Hex | Hex | Non-Hex | |
| Design | Image: Hex design of subject device | Image: Non-Hex design of subject device | Image: Hex design of reference device | Image: Non-Hex design of reference device | Image: Hex design of reference device | Image: Non-Hex design of reference device |
| Diameters (mm) | 4.0/4.5 | 4.0/4.5 | 4.5/5.5/6.5/7.5 | |||
| Lengths (mm) | 4.0/5.5/7.0 | 4.0/5.5/7.0 | 4.0/5.5/7.0 | |||
| Surface Treatment | TiN Coated | Machined Type | TiN Coated |
3) Cemented Abutment
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Image /page/12/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" with "DI" in gray and "O" in pink. Below the letters, the words "Implant Solution" are written in gray.
4) Angled abutment
| Angled abutment | |||
|---|---|---|---|
| Subject Device | Primary Predicate Device | Reference device | |
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UV Active Implant System | DIO UF HSA INTERNAL | |
| SUB- MERGED IMPLANT | UF(II) Narrow Implant System | ||
| 510(K) No. | Not yet assigned | K122519 | K161987 |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design |
| Abutment | |||
| Diameters (mm) | 4.0/4.5/5.5 | 4.5/5.5 | 4.0 |
| Angle (°) | Ø4.0 - 15 | ||
| Ø4.5 - 15, 25 | |||
| Ø5.5 - 15, 25 | Ø4.5 – 15, 25 | ||
| Ø5.5 - 15, 25 | Ø4.0 - 15 | ||
| Surface | |||
| Treatment | TiN Coated | Machined Type | Machined Type |
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Image /page/13/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with "DI" in gray and "O" in pink. Above the "O" is a small pink circle. Below the logo is the text "Implant Solution" in a smaller, sans-serif font.
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UV Active Implant System | UF(II) Narrow Implant System | UF(II) Implant Ssytem |
| 510(K) No. | Not yet assigned | K161987 | K170608 |
| Material | Titanium Grade4(ASTM F67) | Titanium Grade4(ASTM F67) | Titanium Grade4(ASTM F67) |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design |
| Abutment | |||
| Diameters (mm) | 4.0/4.5 | 4.0/4.5 | 4.5/5.5/6.5/7.5 |
| Abutment | |||
| Length(mm) | 4.0/5.5/7.0 | 4.0/5.5/7.0 | 4.0/5.5/7.0 |
| Surface | |||
| Treatment | TiN Coated | Machined Type | TiN Coated |
5) Solid abutment
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Image /page/14/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with "DI" in gray and the "O" in pink. Above the pink "O" is a smaller pink circle. Below the letters is the text "Implant Solution" in a smaller, sans-serif font.
| 6) Ball abutment | |||
|---|---|---|---|
| Subject Device | Primary Predicate Device | Reference Device | |
| Applicant | DIO Corporation | DIO Corporation | DIO Corporation |
| Trade Name | UV Active Implant System | DIO UF HSA INTERNAL SUB- MERGED | |
| IMPLANT SYSTEM | UF(II) Narrow Implant System | ||
| 510(K) No. | Not yet assigned | K122519 | K161987 |
| Classification | |||
| Name | Endosseous Dental Implant, Abutment | ||
| (872.3630) | Endosseous Dental Implant, Abutment | ||
| (872.3630) | Endosseous Dental Implant, Abutment | ||
| (872.3630) | |||
| Product Code | NHA | NHA | NHA |
| Class | II | II | II |
| Material | Ti-6Al-4V ELI (ASTM F136) | ASTM F67 (Ti CP-4) | Ti-6Al-4V ELI (ASTM F136) |
| Design | Image: Ball abutment | Image: Ball abutment | Image: Ball abutment |
| Abutment | |||
| Diameters (mm) | 3.5 | 3.5 | 3.5 |
| Abutment | |||
| Length(mm) | 1.0/2.0/3.0/4.0/5.0/6.0/7.0 | 1.0/2.0/3.0/4.0/5.0/6.0 | 1.0/2.0/3.0/4.0/5.0/6.0/7.0 |
| Surface | |||
| Treatment | TiN Coated | Machined Type | Machined Type |
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Image /page/15/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in gray, with the "O" stylized as a pink circle with a smaller pink circle inside. Below the letters, the words "Implant Solution" are written in a smaller, gray font.
| 7) Mill abutment | ||
|---|---|---|
| Subject Device | Primary | |
| Predicate Device | ||
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | UV Active Implant System | DIO UF HSA INTERNAL SUB-MERGED IMPLANT |
| SYSTEM | ||
| 510(K) No. | Not yet assigned | K122519 |
| Material | Titanium Grade4(ASTM F67) | Titanium Grade4(ASTM F67) |
| Design | Image: Two yellow cylinders | Image: A gray cylinder |
| Abutment | ||
| Diameters (mm) | 4.0/4.5/5.5/6.5/7.5 | 4.0/4.5/5.5/6.5/7.5 |
| Abutment | ||
| Length(mm) | 17.0/17.6/17.8/18.4/19.6/20.4 | 17.0/17.8 |
| Surface | ||
| Treatment | TiN Coated | Machined Type |
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Image /page/16/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, gray font, with the "O" being a pink circle with a smaller pink circle above and to the right. Below the letters, in a smaller gray font, are the words "Implant Solution."
Non-clinical Testing
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device. This testing included:
Sterilization Validation and Shelf Life Testing
Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, and ISO 11737-2 for gamma sterilization and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. For the subject devices provided sterile, accelerated aging shelf life testing was conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results.
- Seal peeling test according to ASTM F88
- Burst test according to ASTM F1140
- Dye penetration test according to ASTM F1929
- Bubble test according to ASTM F2096
- Sterility test
- Appearance
- Dimension Test
Fatigue Test
The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The subject device was tested to evaluate its substantial equivalence according to the following standards. - Fatigue Test according to ISO 14801:2007
Biocompatibility
Biocompatibility was evaluated with accordance to ISO 10993-1 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering exhaustive extractions and potential biological (cytotoxic) reaction.
The following test performed on the subject device.
- Cytotoxicity per ISO 10993-5
The cytotoxicity test was conducted using selected worst-case products with accordance to above mentioned ISO 10993-1 as well as; ISO 10993-5 for Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. and;
ISO 10993-12 for Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials.
No new issues of biocompatibility are raised for the subject devices.
Conclusions
The UV Active Implant System constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, UV Active Implant System sand its predicates are substantially equivalent.