(163 days)
Not Found
No
The summary describes a standard dental implant system made of titanium and various abutments, with no mention of AI or ML technology in its design, function, or intended use.
Yes
The device restores a patient's chewing function after tooth loss, which is a therapeutic rather than diagnostic or preventative function.
No
The provided text describes a dental implant system used for restoring chewing function by surgically placing implants in the jaw. It does not mention any diagnostic capabilities, such as identifying diseases, conditions, or providing information for diagnosis. Its purpose is therapeutic/restorative.
No
The device description explicitly details physical components made of titanium, gold alloy, PEEK, acetal, and Co-Cr-Mo alloy, and describes surgical placement and physical properties, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical placement in the jaw to provide a root form for prosthetic attachment to restore chewing function. This is a surgical and mechanical function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The device is a physical implant made of titanium and other materials, along with various abutments. It's designed to be surgically implanted.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This dental implant system does not fit that description.
N/A
Intended Use / Indications for Use
The Dentis Dental Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. 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. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.
Product codes
DZE, NHA
Device Description
An endosseous dental implant is a device made of Pure Titanium Grade 4. Dentis Dental Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. Dentis Dental Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The surface of the system has been treated with RBM (Resorbable Blasted media). The fixture diameters are 3.7, 4.1, 4.3, 4.8mm and lengths are 7, 8, 10, 12, 14 mm in this system.
s-Clean tapered fixture: . Ø 3.7mm (D) x 7 mm (L) / 14 mm (L) Ø 4.1mm (D) x 7 mm (L) / 8 mm (L) / 10 mm (L) / 12 mm (L) / 14 mm (L) Ø 4.3mm (D) x 7 mm (L) Ø 4.8mm (D) x 7 mm (L)
The contained various abutments in the system are click bridge, cover screw, gold cylinder, solid abutment, couple abutment, angled abutment, healing cap, abutment screw, retaining screw, temporary cylinder, CCM cylinder, and connector.
The rage of the abutment diameters is 1.96 mm to 7.4mm and range of abutment lengths is 3.7mm to 14.25mm. The Connector, MU (Solid, couple, angled, abutment screw), MU Healing cap, and MU Retaining Screw are made of Ti-6Al-4V ELI. The MU click bridge body and MU Temporary Cylinder are made of Titanium Grade 4. The MU Click Bridge Cap is made of PEEK. The MU Gold Cylinder (Body) is made of Gold Alloy. The MU Gold Cylinder (Plastic Sleeve) and MU CCM Cylinder (Plastic Sleeve) are made of Acetal. The MU CCM Cylinder (Body) is made of Co-Cr-Mo alloy.
The possible angulation range of angled abutments is 17 to 30 degrees.
Cover Screw ● Ø 3.6 mm (D) x 5.9 mm (L) . MU Click Bridge Body Ø 4.8 mm (D) x 5.5 mm (L) MU Click Bridge Cap ● Ø 4.6 mm (D) x 4.8 mm (L) . MU Gold Cylinder Ø 4.8 mm (D) x 14.25 mm (L) MU Solid Abutment ● Ø 4.8 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) ● MU Couple Abutment 0 4.8 mm (D) x 4.34 mm (L) / 5.34 mm (L) / 6.34 mm (L) / 7.34 mm (L) . MU Angled Abutment Angle 17° - Ø 4.8 mm (D) x 6.08 mm (L) / 8.08 mm (L) Angle 30° - Ø 4.8 mm (D) x 6.69 mm (L) / 8.69 mm (L) ● MU Healing Cap Ø 5.4 mm (D) x 5.0 mm (L) . MU Abutment Screw (Couple) Ø 1.96 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) . MU Abutment Screw (Angled) Ø 2.32 mm (D) x 7.8 mm (L) . MU Retaining Screw Ø 1.98 mm (D) x 3.7 mm (L) MU Temporary Cylinder ● Ø 4.8 mm (D) x 10.0 mm (L) MU CCM Cylinder ● Ø 4.8 mm (D) x 14.25 mm (L) ● Connector Ø 5.7 mm (D) x 6.7 mm (L) Ø 3.8 mm (D) x 6.8 mm (L) / 6.0 mm (L) Ø 4.5 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 5.4 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 4.0 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 4.3 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 3.8 mm (D) x 9.0 mm (L) / 7.45 mm (L) Ø 4.2 mm (D) x 10.1 mm (L) / 7.95 mm (L) Ø 5.3 mm (D) x 5.15 mm (L), Ø 4.8 mm (D) x 4.45 mm (L) Ø 7.4 mm (D) x 6.85 mm (L) / 5.0 mm (L) Ø 5.3 mm (D) x 6.4 mm (L) / 5.7 mm (L)
The Fixtures are supplied sterile and the abutments are provided non-sterile. The abutments should be 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, anterior mandible
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
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Fatigue Testing performed in accordance with ISO 14801:2007 under the worst case scenario, Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006 and biocompatibility evaluation by comparing materials and manufacturing process with the predicate device, and surface treatment analysis were used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, one behind the other, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
Dentis Co., Ltd. % April Lee Consultant WithUS Consulting 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K150344
Trade/Device Name: Dentis Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 22, 2015 Received: June 26, 2015
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the 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 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
1
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" (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 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,
Susan Runno DDS, MA
Erin Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the color transitioning from a lighter orange at the top to a darker orange at the bottom.
Dentis Co., Lt 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Indication for Use
K150344 510(K) Number (if known):
Device Name: Dentis Dental Implant System
Indication for Use:
The Dentis Dental Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. 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. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.
Prescription Use
AND/OR
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
3
Image /page/3/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter 'D'. The graphic is a gradient, with the bottom being a darker orange and the top being a lighter orange.
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
510(k) Summary
Submitter
Dentis Co., Ltd. Inyeong Lee 99, Seongseoseo-ro, Dalseo-gu Daegu Korea Email: iylee@dentis.co.kr Tel. +82-53-582-2804 Fax. +82-53-583-2806
Official Correspondent
WithUS Group, Inc. April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: Dentis Dental Implant System
- Common Name: Dental Implant System ●
- Classification Name: Endosseous Dental Impant ●
- Primary Product Code: DZE ●
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- . Date prepared: 7/24/2015
General Description
An endosseous dental implant is a device made of Pure Titanium Grade 4. Dentis Dental Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. Dentis Dental Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The surface of the system has been treated with RBM (Resorbable Blasted media). The fixture diameters are 3.7, 4.1, 4.3, 4.8mm and lengths are 7, 8, 10, 12, 14 mm in this system.
- s-Clean tapered fixture: . Ø 3.7mm (D) x 7 mm (L) / 14 mm (L) Ø 4.1mm (D) x 7 mm (L) / 8 mm (L) / 10 mm (L) / 12 mm (L) / 14 mm (L) Ø 4.3mm (D) x 7 mm (L) Ø 4.8mm (D) x 7 mm (L)
The contained various abutments in the system are click bridge, cover screw, gold cylinder, solid abutment, couple abutment, angled abutment, healing cap, abutment screw, retaining screw, temporary cylinder, CCM cylinder, and connector.
The rage of the abutment diameters is 1.96 mm to 7.4mm and range of abutment lengths is 3.7mm to 14.25mm. The Connector, MU (Solid, couple, angled, abutment screw), MU Healing cap, and MU Retaining Screw are made of Ti-6Al-4V ELI. The MU click bridge body and MU Temporary Cylinder are made of Titanium Grade 4. The MU Click Bridge Cap is made of PEEK. The MU Gold Cylinder (Body) is made of Gold Alloy. The MU Gold Cylinder (Plastic Sleeve) and MU CCM Cylinder (Plastic Sleeve) are made of Acetal. The MU CCM Cylinder (Body) is made of Co-Cr-Mo alloy.
4
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
The possible angulation range of angled abutments is 17 to 30 degrees.
- Cover Screw ● Ø 3.6 mm (D) x 5.9 mm (L) . MU Click Bridge Body Ø 4.8 mm (D) x 5.5 mm (L) MU Click Bridge Cap ● Ø 4.6 mm (D) x 4.8 mm (L) . MU Gold Cylinder Ø 4.8 mm (D) x 14.25 mm (L) MU Solid Abutment ● Ø 4.8 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) ● MU Couple Abutment 0 4.8 mm (D) x 4.34 mm (L) / 5.34 mm (L) / 6.34 mm (L) / 7.34 mm (L) . MU Angled Abutment Angle 17° - Ø 4.8 mm (D) x 6.08 mm (L) / 8.08 mm (L) Angle 30° - Ø 4.8 mm (D) x 6.69 mm (L) / 8.69 mm (L) ● MU Healing Cap Ø 5.4 mm (D) x 5.0 mm (L) . MU Abutment Screw (Couple) Ø 1.96 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) . MU Abutment Screw (Angled) Ø 2.32 mm (D) x 7.8 mm (L) . MU Retaining Screw Ø 1.98 mm (D) x 3.7 mm (L) MU Temporary Cylinder ● Ø 4.8 mm (D) x 10.0 mm (L) MU CCM Cylinder ● Ø 4.8 mm (D) x 14.25 mm (L) ● Connector Ø 5.7 mm (D) x 6.7 mm (L) Ø 3.8 mm (D) x 6.8 mm (L) / 6.0 mm (L) Ø 4.5 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 5.4 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 4.0 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 4.3 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 3.8 mm (D) x 9.0 mm (L) / 7.45 mm (L) Ø 4.2 mm (D) x 10.1 mm (L) / 7.95 mm (L) Ø 5.3 mm (D) x 5.15 mm (L), Ø 4.8 mm (D) x 4.45 mm (L) Ø 7.4 mm (D) x 6.85 mm (L) / 5.0 mm (L) Ø 5.3 mm (D) x 6.4 mm (L) / 5.7 mm (L)
The Fixtures are supplied sterile and the abutments are provided non-sterile. The abutments should be sterilized before use.
5
Dentis ( 99. Seongseoseo-ro, Dalseo-gu, Daemi Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Image /page/5/Picture/1 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black, bold letters on the right. The abstract shape appears to be a stylized flame or a curved shape with a circle at the top.
Indication for Use
The Dentis Dental Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. 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. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.
Materials:
The devices are fabricated from CP Titanium (Grade 4) that conforms to ASTM F67 for Dental Implant and Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 for Abutments.
Performance Data (Bench Testing):
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Fatigue Testing performed in accordance with ISO 14801:2007 under the worst case scenario, Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006 and biocompatibility evaluation by comparing materials and manufacturing process with the predicate device, and surface treatment analysis were used to support the decision of substantial equivalence.
Predicate Devices:
The subject device is substantially equivalent to the following predicate device:
- K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd.
Comparison to Predicate Device:
- Fixture
| Subject device | Predicate device | |
|---|---|---|
| Device name | Dentis Dental Implant System | Dentis Dental Implant System |
| 510(k) number | NA | K073486 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | Identical to predicate devices | DENTIS implant is designed for use |
| in edentulous sites in the mandible or | ||
| maxilla for support for a complete | ||
| denture prosthesis, terminal or | ||
| intermediate abutment for fixed |
6
Image /page/6/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or swirl. The text and graphic are the primary elements in the image.
9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806
| | | bridgework, partial dentures, or single
tooth replacements. |
|-------------------|------------------------------------------------|----------------------------------------------------------------|
| Material | Commercially pure titanium GR.4
(ASTM-F-67) | Commercially pure titanium GR.3 and
GR.4 (ASTM-F-67) |
| Design | Morse Taper with Tread | Morse Taper with Tread |
| Fixture diameter | 3.7, 4.1, 4.3, 4.8mm | 3.5, 3.7, 4.1, 4.3, 4.8, 5.5, 6.0mm |
| Fixture length | 7-14mm | 7-14mm |
| Surface treatment | RBM | RBM |
| Gamma sterilized | Yes | Yes |
| Product Code | DZE | DZE |
2) Abutment
| Subject device | Predicate device | |
|---|---|---|
| 510(k) number | NA | K073486 |
| Product Name | Cover Screw | Cover Screw |
| Dimension | Ø 3.6 mm (D) x 5.9 mm (L) | Ø 3.4 mm (D) x 6.5 mm (L) |
| Material | CP Titanium Grade 4 | Ti-6Al-4V ELI |
| Connection | Hex Type | Hex Type |
| Product Name | MU Click Bridge Body, Cap | N/A |
| Dimension | (Body) Ø 4.8 mm (D) x 5.5 mm (L) | |
| (Cap) Ø 4.6 mm (D) x 4.8 mm (L) | N/A | |
| Material | (Body) CP Titanium Grade 4 | |
| (Cap) PEEK | N/A | |
| Product Name | MU Gold Cylinder | i-Clean Gold Cylinder |
| Dimension | Ø 4.8 mm (D) x 14.25 mm (L) | Ø 5.0 mm (D) x 14.3 mm (L) |
| Material | (Body) Gold Alloy | |
| (Plastic Sleeve) Acetal | (Body) Gold Alloy | |
| (Plastic Sleeve) Acetal | ||
| Product Name | MU Solid Abutment | s-Clean Sole Abutment |
| Dimension | Ø 4.8 mm (D) x 9.2 / 10.2 / 11.2 / 12.2 | |
| mm (L) | Ø 4.5 / 5.5 / 6.5 mm (D) x 5.5 mm (L) | |
| Material | Ti-6Al-4V ELI | CP Titanium Grade 4 |
| Product Name | MU Couple Abutment | s-Clean Couple Abutment |
| Dimension | Ø 4.8 mm (D) x 4.34 / 5.34 / 6.34 / | |
| 7.34 mm (L) | Ø 4.5 / 5.5 / 6.5 mm (D) x 5.0 / 7.0 | |
| mm (L) | ||
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Connection | Hex Type | Hex / Non-Hex Type |
| Product Name | MU Angled Abutment | N/A |
| Dimension | Ø 4.8 mm (D) x 6.08 / 8.08 / 6.69 / 8.69 | |
| mm (L) | N/A | |
| Angle | 17°, 30° | N/A |
| Material | Ti-6Al-4V ELI | N/A |
| Connection | Hex Type | N/A |
| Product Name | MU Healing Cap | s-Clean Sole Abutment Healing Cap |
| Dimension | Ø 5.4 mm (D) x 5.0 mm (L) | Ø 4.5 / 5.5 / 6.5 mm (D) x 4.0 mm (L) |
| Material | Ti-6Al-4V ELI | Acetal |
| Product Name | MU Abutment Screw | Abutment Screw |
| Dimension | (1) Ø 1.96 mm (D) x 9.2 mm (L) / 10.2 | |
| mm (L) / 11.2 mm (L) / 12.2 mm (L) | ||
| (2) Ø 2.32 mm (D) x 7.8 mm (L) | Ø 2.32 mm (D) x 9.8 mm (L) | |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Product Name | MU Retaining Screw | N/A |
| Dimension | Ø 1.98 mm (D) x 3.7 mm (L) | N/A |
| Material | Ti-6Al-4V ELI | N/A |
| Product Name | MU Temporary Cylinder | i-Clean Temporary Abutment |
| Dimension | Ø 4.8 mm (D) x 10.0 mm (L) | Ø 5.0 mm (D) x 11.5 mm (L) |
| Material | CP Titanium Grade 4 | CP Titanium Grade 4 |
| Product Name | MU CCM Cylinder | N/A |
| Dimension | Ø 4.8 mm (D) x 14.25 mm (L) | N/A |
| Material | (Body) Co-Cr-Mo Alloy | |
| (Plastic Sleeve) Acetal | N/A | |
| Product Name | Connector | N/A |
| Dimension | 3.8 | N/A |
| Material | Ti-6Al-4V ELI | N/A |
| Sterilization | Steam sterilization by user | Steam sterilization by user |
7
Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic. The graphic is a circle with a curved line extending from the right side of the circle.
9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806 - 182.53.582.2804 / Fax : 82.53.583.2806
8
Dentis Co., Ltc
Image /page/8/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a stylized flame or a curved leaf. To the right of the shape, the word "DENTIS" is written in a bold, sans-serif font. The overall design is clean and modern.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Substantial Equivalence Discussion
The Dentis Dental implant System has a substantially equivalent intended use as the identified predicate. The subject device 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 abutment, and they are all constructed of titanium.
The subject and predicate device are similar in indications, design, technology, functions, dimensions and materials.
The differences between the subject and predicate devices are the addition of the 7mm and 14 mm of the fixtures and various abutments to this subject device.
Conclusion
The Dentis Dental Implant System, subject device of this submission, 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 devices. Therefore, Dentis Dental Implant System and its predicate are substantially equivalent.