(478 days)
Not Found
No
The summary describes a standard dental implant system made of titanium with a treated surface. There is no mention of any software, algorithms, image processing, or AI/ML terms. The performance studies are focused on material properties and sterilization, not algorithmic performance.
Yes
The text describes a dental implant system intended for surgical placement to support dental restorations, which is a therapeutic intervention.
No
This device is a dental implant system designed for surgical placement and restoration. It is not used to diagnose a medical condition or disease.
No
The device description clearly states it is a dental implant made of titanium metal intended for surgical placement, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The OneQ-SL Implant System is a dental implant designed to be surgically placed inside the body (in vivo) in the bone of the jaw.
- Intended Use: The intended use is to support dental restorations, which is a structural and functional purpose within the body, not for diagnostic testing of specimens.
The description clearly indicates a surgically implanted device, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The OneQ-SL Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The OneQ-SL Implant system includes; The i-Clean OneQ Fixtures Internal Octa-connected, non-submerged fixture. The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was tested to evaluate its performance according to the following standards:
- Packaging Test performed in accordance with ISO11607-1:2006 and ISO11607-2:2006
- Sterilization Validation Test performed in accordance with ISO11137-1:2006 and ISO11137-2:2013
- Fatigue Test performed in accordance with ISO14801:2007
- Cytotoxicity Test performed according to ISO 10993-5:2009.
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device.
Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
No additional 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, with three profiles layered on top of each other, creating a sense of depth and dimension.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Dentis Co. Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, CA 91748
Re: K142313
Trade/Device Name: OneQ-SL Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 3, 2015 Received: November 10, 2015
Dear Ms. 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
Page 2 - Ms. April Lee
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 (OS) 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,
Tina Kiang
-S
for Erin I. 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
Indications for Use
510(k) Number (if known) K142313
Device Name OneO-SL Implant System
Indications for Use (Describe)
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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
Submitter
Dentis Co., Ltd. Sun Chul Shin #99, Seongseoseo-ro, Dalseo-gu Daegu city South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
Device Information
Trade Name: OneQ-SL Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 12/09/2015
Description
The OneQ-SL Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The OneQ-SL Implant system includes;
- . The i-Clean OneQ Fixtures Internal Octa-connected, non-submerged fixture
| Platform Diameter | Implant Nominal (Coronal)
Diameter (mm) | Implant Apical
Diameter (mm) | Lengths Available
(mm) |
|-------------------|--------------------------------------------|---------------------------------|---------------------------|
| Regular: Ø 4.8 mm | 3.7 | 3.55 | 7, 8, 10, 12, 14 |
| | 4.2 | 3.7 | 7, 8, 10, 12, 14 |
| | 4.7 | 4.2 | 7, 8, 10, 12, 14 |
| | 5.2 | 4.7 | 7, 8, 10, 12, 14 |
| Wide: Ø 6.5 mm | 4.2 | 3.7 | 7, 8, 10, 12, 14 |
| | 4.7 | 4.2 | 7, 8, 10, 12, 14 |
| | 5.2 | 4.7 | 7, 8, 10, 12, 14 |
| | 6.0 | 4.8 | 7, 8, 10, 12 |
| | 7.0 | 5.75 | 7, 8, 10, 12 |
The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.
Indication for Use
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
Official Correspondent
Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122
4
retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd. ●
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | OneQ-SL Regular / Wide Type | |
| Fixture | ET/SS Implant System | |
| (SSII/III SA Fixture) | ||
| 510(k) Number | K142313 | K120847 |
| Manufacturer | DENTIS CO., LTD. | OSSTEM Implant Co., Ltd. |
| Intended Use | Mandible and Maxilla Endosseous | |
| Dental Implant & Accessories. | Mandible and Maxilla Endosseous | |
| Dental Implant & Accessories. | ||
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 |
| Design | ||
| (Fixture Type) | - Internal Octa-connected |
- Non-Submerged Fixture
- Tapered & straight body | - Internal Octa-connected
- Non-Submerged Fixture
- Straight & Tapered Body |
| Platform Diameter(Coronal) | 4.86.5 | 4.86.0 |
| Fixture Diameter | Regular: Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2
Wide: Ø 4.2, Ø 4.7, Ø 5.2, Ø 6.0,
Ø 7.0 | SSII SA Fixture: Ø 4.1-4.9
SSIII SA Fixture: Ø 3.75-5.0 |
| Fixture Length | Regular: 7, 8, 10 ,12, 14 mm
Wide: 7, 8, 10 ,12, 14mm
14mm not for all diameters | 6~15 mm |
| Indication for use | 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
intended for delayed loading. | ET/SS 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 final or temporary
abutment support for fixed
bridgework. It is intended for delayed
loading. |
| Surface Treatment | SLA | SLA |
| Gamma Sterilized | Yes | Yes |
| Product Code | DZE | DZE |
5
Substantial Equivalence Discussion
The OneQ-SL Implant System has a substantially equivalent intended use as the identified predicates. 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 abutments, and they are all constructed of titanium.
The subject and predicate devices are similar in indications, design, technology, functions, dimensions and materials.
The differences between the subject device and predicate devices are slight differences in fixture's diameters and lengths.
Differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device.
Non-Clinical Test Data
The subject device was tested to evaluate its performance according to the following standards:
- Packaging Test performed in accordance with ISO11607-1:2006 and ISO11607-2:2006 ●
- . Sterilization Validation Test performed in accordance with ISO11137-1:2006 and ISO11137-2:2013
- Fatigue Test performed in accordance with ISO14801:2007
- Cytotoxicity Test performed according to ISO 10993-5:2009 .
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device.
Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
Summary of clinical testing
No additional 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 Implant Co., Ltd. Concludes that the OneQ-SL Implant System is substantially equivalent to the predicate devices as described herein.