(144 days)
No
The 510(k) summary describes a standard dental implant system made of titanium. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The focus is on the physical characteristics, materials, and mechanical performance of the implant.
Yes
The device is a dental implant system indicated for restoring chewing function, which is a therapeutic purpose.
No
Explanation: The s-Clean Tapered II RBM Implant System is described as an endosseous dental implant intended for surgical placement to provide a root form means for prosthetic appliance attachment. Its purpose is to restore chewing function, not to diagnose a condition.
No
The device is a physical dental implant made of titanium, intended for surgical placement in the jaw. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The s-Clean Tapered II RBM Implant System is a dental implant surgically placed directly into the bone of the jaw. It is a physical device used to support prosthetic teeth.
- Intended Use: The intended use is to provide a root form for attaching prosthetic appliances to restore chewing function. This is a surgical and mechanical function, not a diagnostic test performed on a specimen.
The description clearly indicates a surgically implanted device, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The s-Clean Tapered II RBM 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 prostletic appliance attechnent to restore a patient's chewing function. Implants can be placed with a conventional two stage suncical process with a portion. 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 Interforaminal placed implants.
Product codes
DZE
Device Description
The s-Clean Tapered II RBM Implant System is a dental implant made of titanium metal (Titanium grade 4) intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, 1.5° tapered body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. The fixture has been treated with RBM (Resorbable Blasted media).
The s-Clean Tapered II RBM Implant System diameter and lengths are below:
- Diameter Ø 3.7 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- Diameter 0 4.1 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- Diameter Ø 4.3 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- -Diameter Ø 4.8 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm
The packaging has composed of fixture with cover screw. The fixtures are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screw. The purpose of this submission is to add new fixtures.
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
No additional test was performed for this subject system. Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of s-Clean Tapered II RBM Implant System. Gamma Sterilization Validation Test was referenced in reference predicate, K073486. Shelf life Validation Test was referenced in reference predicate, K073486. The testing has been performed to evaluate the substantial equivalence in the 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. No clinical testing was performed for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles facing right, suggesting a sense of forward movement and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
Dentis Co., Ltd. c/o Ms. April Lee Withus Group, Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K160213
Trade/Device Name: s-Clean Tapered II RBM Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: May 10, 2016 Received: May 16, 2016
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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,
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)
Device Name s-Clean Tapered II RBM Implant System
Indications for Use (Describe)
The s-Clean Tapered II RBM 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 prostletic appliance attechnent to restore a patient's chewing function. Implants can be placed with a conventional two stage suncical process with a portion. 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 Interforaminal placed implants.
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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3
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: s-Clean Tapered II RBM Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Primary Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 6/20/2016
Description
The s-Clean Tapered II RBM Implant System is a dental implant made of titanium metal (Titanium grade 4) intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, 1.5° tapered body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. The fixture has been treated with RBM (Resorbable Blasted media).
The s-Clean Tapered II RBM Implant System diameter and lengths are below:
- Diameter Ø 3.7 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- Diameter 0 4.1 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- Diameter Ø 4.3 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm -
- -Diameter Ø 4.8 with lengths of 7mm, 8mm, 10mm, 12mm and 14 mm
The packaging has composed of fixture with cover screw. The fixtures are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screw. The purpose of this submission is to add new fixtures.
4
| K number | Compatible Abutments |
|---|---|
| K073486 | s-Clean Healing Abutment, s-Clean Free-Healing abutment, s-Clean Couple Abutment, s-Clean Sole Abutment, s-Clean Sub Octa Abutment, s-Clean O-ring Abutment |
| K082843 | s-Clean Angled Abutment, s-Clean Healing Abutment |
| K111364 | s-Clean Sole Abutment, s-Clean Hex Abutment, s-Clean Temporary Abutment, s-Clean O-Ring Abutment, s-Clean Free Abutment, s-Clean Sub-Octa Abutment, s-Clean FreeMill Abutment, s-Clean MOA Abutment |
| K150344 | MU Solid Abutment, MU Couple Abutment, MU Angled Abutment |
The subject device is compatible with the following abutments:
Indication for Use
The s-Clean Tapered II RBM 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 is restricted to the anterior mandible based on four splinted Interforaminal placed implants.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- K150344 Dentis Dental Implant System manufactured by Dentis Co., Ltd.
- . K074386 Dentis Dental Implant System manufactured by Dentis Co., Ltd.
| Division | Subject Device | Primary Predicate | Reference Predicate |
|---|---|---|---|
| Device | |||
| Name | s-Clean Tapered II RBM | ||
| Implant System | Dentis Dental Implant | ||
| System | Dentis Dental Implant | ||
| System | |||
| 510(k) | N/A | K150344 | K073486 |
| Manufacture | |||
| r | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. |
| Indication | |||
| for use | The s-Clean Tapered II | ||
| RBM 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 | 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 | The Dentis Dental 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 | |||
| and not dedicated for | |||
| immediate loading. This |
5
| | stage surgical process for
immediate loading.
Immediate loading is
restricted to the anterior | process for immediate
loading. Immediate loading
is restricted to the anterior
mandible based on four | system is intended for
delayed loading. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | mandible based on four
splinted Interforaminal
placed implants. | splinted interforminal placed
implants. | |
| Fixture
Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 |
| Fixture
Diameter | Ø 3.7, Ø 4.1, Ø 4.3, Ø 4.8mm | Ø 3.7, Ø 4.1, Ø 4.3, Ø 4.8m | Ø 3.5, Ø 3.7, Ø 4.1, Ø 4.3,
Ø 4.8, Ø 5.1, Ø 5.5, Ø 6.0,
Ø 6.5, Ø 7.0mm |
| Fixture
Length | 7, 8, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm | 7, 8, 9, 10, 12, 14 mm |
| Design
(Fixture
Type) | - Internal Hex-connected
- Submerged Fixture
- Bone level, Tapered body
- 4 sided cutting edge with
self-tapping | - Internal Hex-Connected - Submerged Fixture
- Bone level, Tapered body
- 4 sided cutting edge with
self-tapping | - Internal Hex-Connected - Submerged Fixture
- Bone level, Tapered body
- 4 sided cutting edge with
self-tapping |
| Surface
Treatment | RBM | RBM | RBM |
| Gamma
Sterilized | Yes | Yes | Yes |
| Product
Code | DZE | DZE, NHA | DZE, NHA |
Substantial Equivalence Discussion
The s-Clean Tapered II RBM 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 indication for use, material, connection structure, packaging, function, using abutments, performance, design, technology and dimensions. The s-Clean Tapered II RBM Implant System is compatible with abutment in s-Clean part of the Dentis Dental Implant System.
This subject device is same with RBM surface treatment of Dentis Dental Implant System of the K150344 that have had same material, manufacturing process, packaging, sterilization condition and surface characteristic.
The differences between the subject device and predicate devices are only the fixture's shape. Thread design of the coronal aspect of the threaded fixture body has changed from the predicate.
6
Non-Clinical Test Data
No additional test was performed for this subject system.
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of s-Clean Tapered II RBM Implant System.
Gamma Sterilization Validation Test was referenced in reference predicate, K073486.
Shelf life Validation Test was referenced in reference predicate, K073486.
The testing has been performed to evaluate the substantial equivalence in the 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.
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 s-Clean Tapered II RBM Implant System is substantially equivalent to the predicate devices as described herein