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.
Device Story
Endosseous dental implant system; titanium grade 4; internal hex connection; 1.5° tapered body; bone level; submerged type. RBM (Resorbable Blasted Media) surface treatment. Surgically placed in upper/lower jaw arches by dental professionals. Provides root form for prosthetic attachment. Supports single or multiple-unit restorations. Immediate loading restricted to anterior mandible with four splinted implants. Supplied sterile via gamma radiation. Used in clinical dental settings to restore patient chewing function.
Clinical Evidence
No clinical testing was performed for this submission. Bench testing, including fatigue testing and sterilization/shelf-life validation, was used to demonstrate substantial equivalence.
Indicated for patients requiring single or multiple-unit prosthetic appliance attachment to restore chewing function via surgical placement in upper or lower jaw arches. Includes conventional two-stage or single-stage surgical processes; immediate loading restricted to anterior mandible using four splinted interforaminal implants.
Regulatory Classification
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.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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.
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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
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# 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.
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| 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<br>Name | s-Clean Tapered II RBM<br>Implant System | Dentis Dental Implant<br>System | Dentis Dental Implant<br>System |
| 510(k) | N/A | K150344 | K073486 |
| Manufacture<br>r | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. |
| Indication<br>for use | The s-Clean Tapered II<br>RBM Implant System is an<br>endosseous dental implant is<br>indicated for surgical<br>placement in the upper and<br>lower jaw arches, to provide<br>a root form means for single<br>or multiple-units prosthetic<br>appliance attachment to<br>restore a patient's chewing<br>function. Implants can be<br>placed with a conventional<br>two stage surgical process<br>with an option for<br>transmucosal healing or they<br>can be placed in a single | The Dentis Dental Implant<br>System is an endosseous<br>dental implant is indicated<br>for surgical placement in the<br>upper and lower jaw arches,<br>to provide a root form means<br>for single or multiple-units<br>prosthetic appliance<br>attachment to restore a<br>patient's chewing function.<br>Implants can be placed with<br>a conventional two stage<br>surgical process with an<br>option for transmucosal<br>healing or they can be placed<br>in a single stage surgical | The Dentis Dental Implant<br>System is indicated for use<br>in partially or fully<br>edentulous mandibles and<br>maxillae, in support of single<br>or multiple-unit restorations<br>including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate<br>abutment support for fixed<br>bridgework. This system is<br>dedicated for one and two<br>stage surgical procedures<br>and not dedicated for<br>immediate loading. This |
{5}------------------------------------------------
| | stage surgical process for<br>immediate loading.<br>Immediate loading is<br>restricted to the anterior | process for immediate<br>loading. Immediate loading<br>is restricted to the anterior<br>mandible based on four | system is intended for<br>delayed loading. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | mandible based on four<br>splinted Interforaminal<br>placed implants. | splinted interforminal placed<br>implants. | |
| Fixture<br>Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 |
| Fixture<br>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,<br>Ø 4.8, Ø 5.1, Ø 5.5, Ø 6.0,<br>Ø 6.5, Ø 7.0mm |
| Fixture<br>Length | 7, 8, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm | 7, 8, 9, 10, 12, 14 mm |
| Design<br>(Fixture<br>Type) | - Internal Hex-connected<br>- Submerged Fixture<br>- Bone level, Tapered body<br>- 4 sided cutting edge with<br>self-tapping | - Internal Hex-Connected<br>- Submerged Fixture<br>- Bone level, Tapered body<br>- 4 sided cutting edge with<br>self-tapping | - Internal Hex-Connected<br>- Submerged Fixture<br>- Bone level, Tapered body<br>- 4 sided cutting edge with<br>self-tapping |
| Surface<br>Treatment | RBM | RBM | RBM |
| Gamma<br>Sterilized | Yes | Yes | Yes |
| Product<br>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
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
