(154 days)
No
The 510(k) summary describes a system of physical dental implants and abutments, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on material properties, sterilization, and shelf life, not algorithmic performance.
Yes
The device is described as an endosseous dental implant system indicated to restore a patient's chewing function, which is a therapeutic purpose.
No
The Dentis Dental Implant System is described as an endosseous dental implant system used to provide a root form for prosthetic appliance attachment to restore chewing function. Its components (fixtures and abutments) are for surgical placement and restoration, not for diagnosing medical conditions.
No
The device description explicitly lists physical components such as fixtures and abutments, which are hardware. The submission also includes non-clinical testing data related to these physical components (e.g., LAL test, biocompatibility, sterilization, shelf life).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system for surgical placement in the jaw to restore chewing function. This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of the implant system (fixtures and abutments) and their surface treatment. This aligns with a medical device intended for implantation, not an IVD.
- Performance Studies: The performance studies focus on non-clinical tests related to the device's physical properties, biocompatibility, sterilization, and shelf life. These are typical tests for a medical device, not an IVD which would involve analytical and clinical performance studies related to the examination of specimens.
In summary, the Dentis Dental Implant System is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dentis Dental Implant System is an endosseous dental implant that 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 when good primary stability has been achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:
-
i-Clean System
Fixture
i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture
Abutment
i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment -
s-Clean System
Fixture
s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture
Abutment
s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment -
e-Clean System
Fixture
e-Clean Tapered Fixture/ e-Clean Tapered II Fixture
Abutment
e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment
The surface of the fixture has been treated with RBM (Resorbable Blasted media).
• i-Clean Tapered Fixture
Diameter: Ø 3.7 mm, Ø 4.1mm, Ø 4.3mm, Ø 4.7mm
Length: 8, 10, 12, 14 mm
• i-Clean Straight Fixture
Diameter: Ø 4.05 mm, Ø 4.25mm, Ø 4.75mm
Length: 8, 10, 12, 14mm
• i-Clean Tapered II Fixture
Diameter: Ø 3.7 mm, Ø 4.1 mm, Ø 4.3 mm, Ø 4.7 mm
Length: 8, 10, 12, 14 mm
• i-Clean SAVE Fixture
Diameter: Ø 5.5mm, Ø 6.0mm
Length: 7, 8, 9, 10, 12 mm
• i-Clean SAVE II Fixture
Diameter: Ø 5.5mm, Ø 6.0mm
Length: 7, 8, 10, 12 mm
• s-Clean Tapered Fixture
Diameter: Ø 3.7 mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm
Length: 8, 10, 12, 14 mm
• s-Clean Straight Fixture
Diameter: Ø 4.1mm, Ø 4.3mm, Ø 4.75mm
Length: 8, 10, 12, 14, 16 mm
• s-Clean SAVE Fixture
Diameter: Ø 5.5mm, Ø 6.0mm
Length: 7, 8, 9, 10, 12 mm
• s-Clean SAVE II Fixture
Diameter: Ø 5.5mm, Ø 6.0mm
Length: 7, 8, 9, 10, 12 mm
• e-Clean Tapered Fixture
Diameter: Ø 3.5mm, Ø 4.1mm, Ø 5.1mm
Length: 8, 10, 12, 14 mm
• e-Clean Tapered II Fixture
Diameter: Ø3.5mm, Ø4.1mm, Ø5.1mm
Length: 8, 10, 12, 14 mm
The packaging has composed of fixture with cover screw. The fixtures, cover screws and healing abutments are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screws. The abutments are provided separately and should be sterilized by user 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
Prescription Use
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 Test Data:
- Limulus amebocyte lysate (LAL) test plan for endotoxin sampling of devices labeled as sterile, in accordance with USP and USP
- Biocompatibility Tests for PEEK material based on ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization and Irritation) referenced in K150344
- Sterilization Test according to ISO 11137-1,-2,-3 referenced in K073486
- End user sterilization test according to ISO 17665-1, -2 referenced in K161244
- Shelf life Validation Test according to ISO 11607-1. -2. and ASTM F1980-07 referenced in K153639 (Fixtures) and K161244 (Fixtures and Healing Abutment)
Results: The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The fixture materials of the pure titanium and Ti-6Al-4V ELI are biocompatible because both materials were cleared in K073486 and it demonstrates substantial equivalence of materials. The Peek material used for the subject device and predicate device (K150344) is exactly same from same manufacturer. We provided the full biocompatibility test report of the Peek material in K150344. The test reports support substantial equivalences because same manufacturing process and material are used for subject and predicate devices. The sterilization validation test was performed for predicate device, K073486 and leveraged for the subject device because the sterilization method, standard, facility, and SAL are exactly same. The RBM surface characterization was provided in the predicate device, K073486 according to "Guidance for FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments and it is exactly same for the subject device. The reference predicates, OneQ SL s-Clean Implant System (K153639) and s-Clean OneQ-SL Narrow Implant System (K161244), supports substantial equivalence of shelf life.
Clinical Testing: No clinical testing was performed for this submission.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K171027
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: July 31, 2017 Received: August 8, 2017
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.
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 (reporting of medical devicerelated 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 (DICE) 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 (DICE) 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,
Andrew I. Steen -S
- for Lori A. Wiggins, MPT, CLT 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171027
Device Name Dentis Dental Implant System
Indications for Use (Describe)
The Dentis Dental Implant System is an endosseous dental implant that 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 when good primary stability has been achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange swirl design on the left, followed by the word "DENTIS" in black, bold letters. The swirl design appears to be a stylized representation of a tooth or a dental-related symbol.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
510(K) Summary
Submitter
Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 South Korea Phone: +82-53-583-2804 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: 909-274-9971 Fax: 909-460-8122
Device Information
Trade Name: Dentis Dental Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Primary Product Code: DZE Secondary Product Code: NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 9/5/2017
Description
The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:
1) i-Clean System
Fixture
i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture
Abutment
i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment
4
Image /page/4/Picture/0 description: The image shows the logo for Dentis. The logo consists of an orange swirl on the left and the word "DENTIS" in black font on the right. The swirl is a gradient of orange, with the darkest shade at the bottom and the lightest shade at the top.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
2) s-Clean System
Fixture
s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture
Abutment
s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment
3) e-Clean System
Fixture
e-Clean Tapered Fixture/ e-Clean Tapered II Fixture
Abutment
e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment
The surface of the fixture has been treated with RBM (Resorbable Blasted media).
The dimensions of the fixtures are below:
- . i-Clean Tapered Fixture
| Diameter | Length |
|---|---|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 4.3mm | 8, 10, 12, 14 mm |
| Ø 4.7mm | 8, 10, 12, 14 mm |
. i-Clean Straight Fixture
| Diameter | Length |
|---|---|
| Ø 4.05 mm | 8, 10, 12, 14mm |
| Ø 4.25mm | 8, 10, 12, 14mm |
| Ø 4.75mm | 8, 10, 12, 14mm |
● i-Clean Tapered II Fixture
| Diameter | Length |
|---|---|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1 mm | 8, 10, 12, 14 mm |
| Ø 4.3 mm | 8, 10, 12, 14 mm |
| Ø 4.7 mm | 8, 10, 12, 14 mm |
5
Image /page/5/Picture/0 description: The image contains the word "DENTIS" in a bold, sans-serif font. To the left of the word is an orange graphic. The graphic appears to be a stylized flame or abstract shape, with a gradient from a darker orange at the base to a lighter orange at the tip.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
- i-Clean SAVE Fixture .
| Diameter | Length |
|---|---|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |
i-Clean SAVE II Fixture .
| Diameter | Length |
|---|---|
| Ø 5.5mm | 7, 8, 10, 12 mm |
| Ø 6.0mm | 7, 8, 10, 12 mm |
- s-Clean Tapered Fixture
| Diameter | Length |
|---|---|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 4.3mm | 8, 10, 12, 14 mm |
| Ø 4.8mm | 8, 10, 12, 14 mm |
. s-Clean Straight Fixture
| Diameter | Length |
|---|---|
| Ø 4.1mm | 8, 10, 12, 14, 16 mm |
| Ø 4.3mm | 8, 10, 12, 14, 16 mm |
| Ø 4.75mm | 8, 10, 12, 14, 16 mm |
● s-Clean SAVE Fixture
| Diameter | Length |
|---|---|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |
. s-Clean SAVE II Fixture
| Diameter | Length |
|---|---|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |
- . e-Clean Tapered Fixture
| Diameter | Length |
|---|---|
| Ø 3.5mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 5.1mm | 8, 10, 12, 14 mm |
e-Clean Tapered II Fixture .
| Diameter | Length |
|---|---|
| Ø3.5mm | 8, 10, 12, 14 mm |
| Ø4.1mm | 8, 10, 12, 14 mm |
| Ø5.1mm | 8, 10, 12, 14 mm |
6
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
The packaging has composed of fixture with cover screw. The fixtures, cover screws and healing abutments are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screws. The abutments are provided separately and should be sterilized by user before use.
Indication for Use
The Dentis Dental Implant System is an endosseous dental implant that 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 when good primary stability has been achieved and with appropriate occlusal loading.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- . K073486, Dentis Dental Implant System by Dentis Co., Ltd. - Primary predicate
- K142313, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
- K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd. .
1 Fixtures
- a. i-Clean System
| a. | Subject device | Primary Predicate device | Reference Predicate Device | Reference Predicate Device |
|---|---|---|---|---|
| Device name | Dentis Dental | |||
| Implant System | Dentis Dental | |||
| Implant System | OneQ-SL s-Clean | |||
| Implant System | s-Clean OneQ-SL | |||
| Narrow Implant | ||||
| System | ||||
| 510(k) number | NA | K073486 | K142313 | K161244 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | The Dentis | |||
| Dental Implant | ||||
| System is an | ||||
| endosseous | ||||
| dental implant | ||||
| that 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 | 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 | The OneQ-SL | |||
| Implant System is | ||||
| indicated for use in | ||||
| partially or fully | ||||
| edentulous mandibles | ||||
| and maxillae, in | ||||
| support of single or | ||||
| multiple-unit | ||||
| restorations including; | ||||
| cemented retained, | ||||
| screw retained, or | ||||
| overdenture | ||||
| restorations, and | ||||
| terminal or | ||||
| intermediate abutment | ||||
| support for fixed | ||||
| bridgework. This | ||||
| system is dedicated | The s-Clean OneQ- | |||
| SL Narrow Implant | ||||
| System (3.0, | ||||
| 3.3mm) may be | ||||
| used as an artificial | ||||
| root structure for | ||||
| single tooth | ||||
| replacement of | ||||
| mandibular central | ||||
| and lateral incisors | ||||
| and maxillary | ||||
| lateral incisors. | ||||
| The implants may | ||||
| be restored | ||||
| immediately |
- with a temporary
prosthesis that is |
7
Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. 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.
8
9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806 - Tel : 82.53.582.2804 /Fax : 82.53.583.2806
| Gamma sterilized | Yes | Yes | Yes | Yes |
|---|---|---|---|---|
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Shelf Life | 8 years | 2 years | 1 years | 8 years |
| Brief Comparison | Similarities: The subject device has equivalent indications for use, material, | |||
| surface treatment, dimension, sterilization, and shelf life as predicate devices. | ||||
| Differences: New fixtures added to include Straight, Tapered II, and SAVE II | ||||
| designs that have slightly different thread profiles and sizes; new diameter sizes | ||||
| added for Tapered (Ø 4.1, 4.7mm) and SAVE (Ø 5.5, 6.0mm) designs. All | ||||
| fixtures with new co-packaging to include Cover Screw. With different shapes | ||||
| and sizes added, leveraged information from fixtures in predicate (K073486) | ||||
| justified to show worst case by comparing the measurements of proposed fixtures | ||||
| from each system. Therefore, addition of fixtures does not raise any risks and | ||||
| questions. The reference predicates, s-Clean OneQ-SL Narrow Implant System | ||||
| (K161244), supports substantial equivalence of shelf life. |
b. s-Clean System
| Subject device | Predicate device | Reference Predicate Device | Reference Predicate Device | |
|---|---|---|---|---|
| Device name | Dentis Dental Implant System | Dentis Dental Implant System | OneQ-SL s-Clean Implant System | s-Clean OneQ-SL Narrow Implant System |
| 510(k) number | NA | K073486 | K153639 | K161244 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | The Dentis Dental Implant System is an endosseous dental implant that 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 | 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 | The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading | The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an |
| function. | loading. Immediate | artificial root | ||
| Implants can be | loading is restricted to | structure for | ||
| placed with a | the anterior mandible | multiple tooth | ||
| conventional | based on four splinted | replacement of | ||
| two stage | Interforaminal placed | mandibular | ||
| surgical process | implants. | incisors, or | ||
| with an option | 3) for denture | |||
| for | stabilization using | |||
| transmucosal | multiple implants | |||
| in the anterior | ||||
| healing or they | mandible and | |||
| maxilla. | ||||
| can be placed in | The implants may | |||
| a single stage | ||||
| surgical process | be placed in | |||
| for immediate | immediate | |||
| loading when | function when | |||
| good primary | good primary | |||
| stability has | stability has been | |||
| been achieved | achieved and with | |||
| and with | appropriate occlusal | |||
| appropriate | loading. | |||
| occlusal | ||||
| loading. | ||||
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 | Ti-6Al-4V ELI |
| Tapered, SAVE, | - Tapered: Internal | Straight and | ||
| Straight, and | Hex connected, | tapered implant | ||
| Submerged, micro- | • Internal Hex- | |||
| connected | body | |||
| SAVE II | thread design | 3 sided cutting | ||
| Design | designs, each | |||
| Internal Hex | ||||
| connected | - SAVE: Abutment | |||
| with connection of | ||||
| 11° morse taper | ||||
| shape, micro-thread | ||||
| design | • Bone level | |||
| • Tapered & | ||||
| straight body | • edge of bottom | |||
| • Internal double | ||||
| hex connection | ||||
| • Bone level | ||||
| design. | ||||
| Fixture diameter | ||||
| (Ø) | 3.7, 4.1, 4.3, | |||
| 4.8, 5.5, 6.0mm | 3.5, 3.7, 4.1, 4.3, 4.8, | |||
| 5.5, 6.0mm | 3.7, 3.9, 4.2, 4.7, | |||
| 5.2, 6.0, 7.0, 7.0 mm | 3.0, 3.3 mm | |||
| Fixture length | 7, 8, 9, 10, 12, | |||
| 14 mm | 7, 8, 10, 12, 14 mm | 7, 8, 10 ,12, 14 mm | 10 ,12, 14 mm | |
| Surface | ||||
| treatment | RBM | RBM | SLA | SLA |
| Gamma | ||||
| sterilized | Yes | Yes | Yes | Yes |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Shelf Life | 8 years | 2 years | 1 years | 8 years |
9
Image /page/9/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, abstract symbol that resembles a flame or a stylized letter 'J'. The symbol is composed of curved lines that create a sense of movement and energy. The overall design is clean and modern, suggesting a professional and innovative company.
10
Image /page/10/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange swirl design. The swirl is made up of two curved lines that start at a single point and then separate, with one line curving around the other.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
| Brief
Comparison | Similarities: The subject device has equivalent indications for use, material,
surface treatment, dimension, sterilization, and shelf life as predicate devices.
Differences: New fixtures added to include Straight and SAVE II designs that
have slightly different thread profiles and sizes; new diameter sizes added for
Tapered (Ø 4.1mm) and SAVE (Ø 5.5mm) designs. All fixtures with new co-
packaging to include Cover Screw. With different shapes and sizes added,
leveraged information from fixtures in predicate (K073486) justified to show
worst case by comparing the measurements of proposed fixtures from each
system. Therefore, addition of fixtures does not raise any risks and questions. The
reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244),
supports substantial equivalence of shelf life. |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
c. e-Clean System
| Subject device | Predicate device | Reference Predicate Device | Reference Predicate Device | |
|---|---|---|---|---|
| Device name | Dentis Dental | |||
| Implant System | Dentis Dental | |||
| Implant System | OneQ-SL s- | |||
| Clean Implant | ||||
| System | s-Clean OneQ-SL | |||
| Narrow Implant | ||||
| System | ||||
| 510(k) number | NA | K073486 | K153639 | K161244 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | The Dentis Dental | |||
| Implant System is | ||||
| an endosseous | ||||
| dental implant that | ||||
| 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 | ||||
| when good primary | ||||
| stability has been | 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 bridgework, | ||||
| partial dentures, | ||||
| or single tooth | ||||
| replacements. | The OneQ-SL s- | |||
| Clean Implant | ||||
| System is indicated | ||||
| for use in partially or | ||||
| fully edentulous | ||||
| mandibles and | ||||
| maxillae, in support | ||||
| of single or multiple | ||||
| unit restorations | ||||
| including; cemented | ||||
| retained, screw | ||||
| retained, or | ||||
| overdenture | ||||
| restorations, and | ||||
| terminal or | ||||
| intermediate | ||||
| abutment support for | ||||
| fixed bridgework. | ||||
| This system is | ||||
| dedicated for one and | ||||
| two stage surgical | ||||
| procedures. This | ||||
| system is intended for | ||||
| delayed loading. | The s-Clean OneQ- | |||
| SL Narrow Implant | ||||
| System (3.0, 3.3mm) | ||||
| may be used as an | ||||
| artificial root | ||||
| structure for single | ||||
| tooth replacement of | ||||
| mandibular central | ||||
| and lateral incisors | ||||
| and maxillary lateral | ||||
| incisors. | ||||
| The implants may be | ||||
| restored | ||||
| immediately |
- with a temporary
prosthesis that is not
in functional
occlusion, - when splinted
together as an
artificial root
structure for
multiple tooth
replacement of
mandibular incisors,
or - for denture
stabilization using
multiple implants in
the anterior mandible
and maxilla. |
| | achieved and with
appropriate occlusal
loading. | | | The implants may be
placed in immediate
function when
good primary stability
has been achieved and
with appropriate
occlusal loading. |
| Material | CP Titanium Gr.4 | Commercially
pure titanium
GR.4 (ASTM-F- -
| CP Titanium Gr.4 | Ti-6Al-4V ELI |
| Design | Tapered and
Tapered II
designs, each
External Hex
connected | Internal Hex
connected,
Submerged,
External Hex
connected | • Internal Hex-
connected
• Bone level
• Tapered &
straight body | • Straight and tapered
implant body
• 3 sided cutting edge
of bottom
• Internal double hex
connection
• Bone level design. |
| Fixture diameter
(Ø) | 3.5, 4.1, 5.1mm | 3.3, 3.5, 4.1,
5.1mm | 3.7, 3.9, 4.2, 4.7,
5.2 mm | 3.0, 3.3 mm |
| Fixture length | 8, 10, 12, 14 mm | 8, 10, 12, 14 mm | 7, 8, 10 ,12, 14 mm | 10 ,12, 14 mm |
| Surface
treatment | RBM | RBM | SLA | SLA |
| Gamma
sterilized | Yes | Yes | Yes | Yes |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Shelf Life | 8 years | 2 years | 1 years | 8 years |
| Brief
Comparison | - Similarities: The subject device has equivalent indications for use, material,
surface treatment, dimension, sterilization, and shelf life as predicate devices.
- Differences: New fixture added to include Tapered II design that has slightly
different tread profiles and sizes. All fixtures with new co-packaging to include
Cover Screw or Cover Screw with Mount and Mount Screw. With different
shapes and sizes added, leveraged information from fixtures in predicate
(K073486) justified to show worst case by comparing the measurements of
proposed fixtures from each system. Therefore, addition of fixtures does not raise
any risks and questions. The reference predicates, s-Clean OneQ-SL Narrow
Implant System (K161244), supports substantial equivalence of shelf life. | | | |
| | Subject device | Primary Predicate | Reference Predicate | |
| 510(k) number | NA | K073486 | K161244 | |
| Product Name | Solid Abutment | Solid Abutment | - | |
| Dimension | Ø3.5 mm (D) x
8, 9, 10.5, 12mm (L) | Ø3.5 mm (D) x
9, 10.5, 12 mm (Length) | - | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | |
| Product Name | Excellent Solid
Abutment | Excellent Solid Abutment | - | |
| Dimension | Ø4.3 mm (D) x
7.88, 8.78, 10.38, 11.88mm
(L) | Ø4.3 mm (D) x
8.78, 10.38, 11.88mm (L) | - | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | |
| Product Name | Octa Abutment | Octa Abutment | - | |
| Dimension | Ø3.5, 4.3mm (D) x 7, 7.3mm
(L) | Ø3.5mm (D) x 7mm (L) | - | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | |
| Product Name | SynOcta Abutment | SynOcta Abutment | - | |
| Dimension | Ø3.5mm (D) x 8.3 mm (L) | Ø3.5mm (D) x 8.3 mm (L) | - | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | |
| Product Name | Healing Abutment | Healing Abutment | Healing Abutment | |
| Dimension | Ø5.5, 6.4, 6.9mm(D) x
7.1, 8.1, 8.3, 9.1, 9.3 9.6,
10.6, 10.8 12.1mm(L) | Ø5.5, 6.4, 6.9mm(D) x
8.1, 9.1, 10.6mm(L) | Ø4.0 mm(D) x
7.9, 8.4, 8.9, 9.4, 9.9,
10.4,10.9,11.4mm(L) | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | |
| Product Name | InOcta Abutment | InOcta Abutment | - | |
| Dimension | Ø5.2, 6.9 mm (D) x
8.75, 9.75, 10.75, 11.75,
8.85, 9.85, 10.85, 11.85 mm
(L) | Ø5.2mm (D) x
8.75, 9.75, 10.75,
11.75mm (L) | - | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | |
| Product Name | Temporary
Abutment | Temporary Abutment | Temporary Abutment | |
| Dimension | Ø5.0, 5.2, 6.8 6.9 mm (D) x
11.5 12.75, 13.75, 14.75,
15.75, 12.85, 13.85, 14.85,
15.85 mm (L) | Ø5.0 5.2 mm (-D) x 11.5
12.75, 13.75, -14.75 mm
(L) | Ø 4.0 mm (D) x 12.5
and 13 mm (L) | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | |
| Product Name | Octa Healing Cap | Octa Healing Cap | - | |
| Dimension | Ø4.9, 6.6mm (D) x 4.0, 4.3
mm (L) | Ø4.9mm (D) x 4.0 mm (L) | - | |
| Material | Acetal, Pure Titanium
(Grade 4) | Acetal, Pure Titanium
(Grade 4) | - | |
| Product Name | Gold UCLA
Abutment | Gold UCLA Abutment | Gold UCLA Abutment | |
| Dimension | Ø5.0, 5.1, 6.8 mm (D) x
14.25, 14.3, 14.65, 14.7,
15.6mm (L) | Ø5.0, 5.1mm (D) x
14.3,14.7mm (L) | Ø 4.0 mm (D) x 14.5
and 15 mm (L) | |
| Material | Gold Alloy, Acetal | Gold Alloy, Acetal | Gold Alloy, Acetal | |
| Product Name | Solid Healing Cap | Solid Healing Cap | Healing Cap | |
| Dimension | Ø5.4, 5.5, 5.9, 7mm (D) x
4.7, 5.5, 6.4, 6.5, 8.0, 9.4,
9.5mm (L) | Ø5.5, 5.9 mm (D) x
4, 5.5, 7mm (L) | Ø 4.6 mm (D) x 6, 7.5
and 9 mm (L) | |
| Material | Acetal | Acetal | Acetal | |
| Product Name | O-ring Abutment | O-ring Abutment | O-ring Abutment | |
| Dimension | Ø3.5, 4.3mm (D) x 9.1, 9.4,
11.1, 11.4, 13.1, 13.4 mm
(L) | Ø3.5mm (D) x
9.1,11.1,13.1mm (L) | Ø 3.5 mm (D) x 10 and
12 mm (L) | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | |
| Sterilization | Steam sterilization by user | Steam sterilization by user | Steam sterilization by
user | |
| Product Code | NHA | NHA | NHA | |
| Shelf Life of
Healing Abutment | 8 years | 5 years | 8 years | |
| Sterilization
method for
Healing abutment | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Brief Comparison | The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244)
supports substantial equivalence of shelf life of healing abutment. | | | |
| | Subject device | Primary Predicate | Reference Predicate | |
| 510(k) number | NA | K073486 | K161244 | |
| Product Name | Healing Abutment | Healing Abutment | Healing Abutment | |
| Dimension | Ø 4.0, 4.5, 4.8, 5.0, 5.5, 6.0,6.5,7.0, 7.5mm (D) X 9.5, 10.0, 10.5, 11.0, 11.5, 12.0, 12.5, 13.0, 13.5, 14.0 mm (L) | Ø 4.5, 5.0, 5.5, 6.0, 6.5,7.0mm (D) X 9.5, 10.0, 10.5, 11.0, 12.0, 13.0, 13.5, 14.0 mm (L) | Ø4.0 mm(D) x 7.9, 8.4, 8.9, 9.4, 9.9, 10.4,10.9,11.4mm(L) | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | |
| Product Name | Free Healing Abutment | Free Healing Abutment | - | |
| Dimension | Ø 4.0, 4.5, 5.5, 6.5mm(D) x 8.8, 9.3, 10.8, 11.3mm(L) | Ø 4.5, 5.5mm(D) x 9.3,11.3mm(L) | - | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | |
| Product Name | Sole Abutment Healing Cap | Sole Abutment Healing Cap | - | |
| Dimension | Ø5.1, 5.8, 6.3, 6.8mm (D) x 7 mm (L) | Ø4.5, 5.5, 6.5mm(D) x 7mm(L) | - | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | |
| Product Name | Sole Abutment | Sole Abutment | Sole Abutment | |
| Dimension | Ø4.5, 4.8, 5.5, 6.0, 6.5 mm (D) x 12.5, 13.0, 13.5, 14,15, 16, 17 mm (L) | Ø4.5, 5.5, 6.5 x 0.8, 1.5, 2.0, 2.5, 3.5, 4.5, 5.5mm(Cuff) | Ø 4.0 mm (D) x 9.4, 10.4, 10.9, 11.9, 12.4, 12.9, 13.4, 14.4, 14.9, 15.9 mm (L) | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | |
| Product Name | Couple Abutment | Couple Abutment | - | |
| Dimension | Ø4.0, 4.5, 4.8, 5.5, 6.0, 6.5 mm (D) x 7.3, 7.44, 7.8, 7.94, 8.3, 8.44, 8.94, 8.8, 8.94, 9.3, 9.44, 9.8, 9.94, 10.3, 10.94, 10.44, 10.8, 10.94, 11.3,11.44, 11.8, 11.94, 12.3, 12.44,12.8, 12.94, 13.8, 13.3, 13.44, 13.94, 14.8, 14.94 mm (L) | Ø4.5,5.5, 6.5mm (D) x 1.0, 1.5, 2.0,2.5, 3.5, 4.5, 5.5 mm (Cuff) | - | |
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | |
| Product Name | O-Ring Abutment | O-Ring Abutment | O-Ring Abutment | |
| Dimension | Ø3.4, 4.5mm (D) x
10.1, 11.6, 13.6 mm (L) | Ø3.4, 4.5mm(D) x 0.5, 2,
4mm(Cuff) | Ø 3.5 mm (D) x 10, 12
mm (L) | |
| Material | Ti-6Al-4V ELI(Grade 5) | | Ti-6Al-4V ELI (Grade 5) | |
| Product Name | Sub-Octa Abutment | Sub-Octa Abutment | - | |
| Dimension | Ø4.8mm (D) x 9.15, 9.65,
10.65, 11.65, 12.65, 13.65
mm (L) | Ø4.8mm(D) x 1.0, 1.5,
2.5, 3.5, 4.5, 5.5mm (Cuff) | | |
| Material | Ti-6Al-4V ELI(Grade 5) | | - | |
| Product Name | Abutment screw | Abutment screw | Abutment screw | |
| Dimension | Ø2.32mm (D) x 8.8, 9.2, 9.4,
9.8, 9.95, 10.5 mm (L) | Ø2.32mm(D) x 9.8mm(L) | Ø 2.03 mm (D) x 9 mm
(L) | |
| Material | Ti-6Al-4V ELI(Grade 5) | | Ti-6Al-4V ELI(Grade 5) | |
| Product Name | Temporary Abutment | Temporary Abutment | Temporary Abutment | |
| Dimension | Ø4.5, 4.8, 5.5, 6.0, 6.5mm
(D) x 13.54, 13.4 mm (L) | Ø4.5, 5.5, 6.5mm(D) x
13.54, 13.4mm (L) | Ø 4.0 mm (D) x 12.5
and 13 mm (L) | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | |
| Product Name | Gold UCLA Abutment | Gold UCLA Abutment | Gold UCLA Abutment | |
| Dimension | Ø4.5 mm (D) x 15.34, 15.4
mm (L) | Ø4.5 mm (D) x 15.34,
15.4 mm (L) | Ø 4.0 mm (D) x 14.5, 15
mm (L) | |
| Material | Gold Alloy, Acetal | Gold Alloy, Acetal | Gold Alloy, Acetal | |
| Product Name | CCM Abutment | - | CCM Abutment | |
| Dimension | Ø4.5 mm (D) x 15.39, 15.44
mm (L) | | Ø 4.0 mm (D) x 14.5, 15
mm (L) | |
| Material | Co-Cr-Mo Alloy | - | Co-Cr-Mo Alloy | |
| Sterilization | Steam sterilization by user | Steam sterilization by user | Steam sterilization by
user | |
| Product Code | NHA | NHA | NHA | |
| Shelf Life of
Healing Abutment | 8 years | 5 years | 8 years | |
| Sterilization
method for
Healing abutment | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Brief Comparison | The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244)
supports substantial equivalence of shelf life. | | | |
11
Image /page/11/Picture/0 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic. The graphic is a circle with an orange swirl around it. The swirl starts thin and gets thicker as it goes around the circle.
12
Image /page/12/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange, abstract logo. The logo appears to be a stylized, curved shape, possibly representing a flame or a stylized letter. The overall impression is a corporate logo for a company named Dentis.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
② Abutment
- a. i-Clean System
13
Image /page/13/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 flame or a stylized letter "D". The graphic is a gradient of orange, with the darkest shade at the bottom and the lightest at the top.
14
Image /page/14/Picture/0 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a swirl. The graphic is lighter at the top and darker at the bottom.
- b. s-Clean System
15
Image /page/15/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic that resembles a curved flame or a stylized letter 'D'. The overall impression is that of a company logo or brand name.
16
Image /page/16/Picture/0 description: The image shows the word "DENTIS" with a stylized orange swirl to the left of the word. The word "DENTIS" is written in a bold, sans-serif font. The swirl is a gradient of orange, with the darker shades at the bottom and lighter shades at the top. The image is likely a logo for a dental company or organization.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
| Subject Device | Previously Cleared Product | |
|---|---|---|
| 510(K) Number | K171027 | K150344 |
| Manufacturer | Dentis Co., Ltd | Dentis Co., Ltd. |
| Device Name | Dentis Dental Implant System | Dentis Dental Implant System |
| Model Name | Temporary Abutment | MU Click Bridge Cap |
| Manufacturing | ||
| Process | Identical | Identical |
| Materials | Identical | PEEK (Polyether ether ketone) |
| Body contact | Identical | Direct (Mucosal Membrane) |
| Contact Duration | Identical | Class B (> 24hr, and USP |
| Below tests were performed for predicate devices and leveraged for the subject device: |
- Biocompatibility Tests for PEEK material based on ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization and Irritation) referenced in K150344
- . Sterilization Test according to ISO 11137-1,-2,-3 referenced in K073486
- End user sterilization test according to ISO 17665-1, -2 referenced in K161244 ●
- . Shelf life Validation Test according to ISO 11607-1. -2. and ASTM F1980-07 referenced in K153639 (Fixtures) and K161244 (Fixtures and Healing Abutment)
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
The fixture materials of the pure titanium and Ti-6Al-4V ELI are biocompatible because both materials were cleared in K073486 and it demonstrates substantial equivalence of materials.
The Peek material used for the subject device and predicate device (K150344) is exactly same from same manufacturer. We provided the full biocompatibility test report of the Peek material in K150344. The test
18
Image /page/18/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange swirl shape on the left, followed by the word "DENTIS" in bold, black letters. The swirl shape appears to be a stylized representation of a tooth or a dental instrument.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
reports support substantial equivalences because same manufacturing process and material are used for subject and predicate devices.
The sterilization validation test was performed for predicate device, K073486 and leveraged for the subject device because the sterilization method, standard, facility, and SAL are exactly same. The RBM surface characterization was provided in the predicate device, K073486 according to "Guidance for FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments and it is exactly same for the subject device. The reference predicates, OneQ SL s-Clean Implant System (K153639) and s-Clean OneQ-SL Narrow Implant System (K161244), supports substantial equivalence of shelf life.
Summary of clinical testing
No clinical testing was performed for this submission.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the Dentis Dental Implant System is substantially equivalent to the predicate devices as described herein