The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Device Story
S-mini active Fixture is a one-body, root-form endosseous dental implant; placed in alveolar bone to replace missing teeth function; provides temporary support for prosthetic devices during permanent implant healing. Features self-tapping thread design; available in various diameters (2.5-3.5mm) and lengths (7.0-15.0mm). Used by dental professionals in clinical settings. Implanted into mandibular or maxillary bone; provides connection point for prosthetic components. Benefits patient by restoring chewing function during healing phase. Device is provided sterile.
Clinical Evidence
Bench testing only. Biocompatibility testing per ISO 10993 series; fatigue testing per ISO 14801; bacterial endotoxin testing per ANSI/AAMI ST72, USP <161>, and USP <85>; dimensional, visual, and torque testing. SLA surface characteristics validated via SEM and chemical analysis compared to reference predicate K120503. Sterilization and shelf-life validated.
Technological Characteristics
Material: Ti-6Al-4V ELI (ASTM F136). Surface: SLA (Sandblasted with Large-grit and Acid-etching). Design: One-body root-form fixture with self-tapping threads. Dimensions: Diameters 2.5/3.0/3.5mm; Lengths 7.0-15.0mm. Sterilization: Gamma radiation. Standalone mechanical device.
Indications for Use
Indicated for partially edentulous patients requiring temporary prosthetic support for missing maxillary lateral incisors or mandibular central and lateral incisors during the healing phase of permanent endosseous dental 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2018
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K181178
Trade/Device Name: S-mini active Fixture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 26, 2018 Received: May 2, 2018
# 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.
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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 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -S
for Tina Kiang, Ph.D. 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}------------------------------------------------
# Indications for Use
Expiration Date: 06/30/2020 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known) K181178
Device Name S-mini active Fixture
#### Indications for Use (Describe)
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
> 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:
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{3}------------------------------------------------
#### 510(k) Summary
#### Submitter
Neobiotech Co., Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: kylee@neobiotech.com Tel. +82-2-582-2885 Fax. +82-2-582-2883
# Device Information
- Trade Name: S-mini active Fixture
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form
- . Primary Product Code: DZE
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- Date Prepared: 07/23/2018
#### Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- . K112540, S-Mini Implant system manufactured by Neobiotech Co., Ltd.
Reference Predicates
- K122171, MS SA Implant System by OSSTEM Implant Co.,Ltd. .
- K120503, CMI IMPLANT IS II ACTIVE by Neobiotech Co., Ltd. ●
#### Indication for Use:
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
#### Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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# Device Description
S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136.
The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching).
It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping.
The fixtures' diameters and lengths are available as:
- Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L) .
- Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
- . Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L)
Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.
#### Materials:
The fixture is fabricated from Ti-6A1-4V ELI of ASTM F136.
#### Summary of Technological Characteristics
#### 1) S-mini active Fixture
| | Subject Device | Primary Predicate | Reference Predicate |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd | OSSTEM Implant Co.,Ltd. |
| Device Name | S-mini active Fixture | S-Mini Implant system | MS SA Implant System |
| 510(k) Number | K181178 | K112540 | K122171 |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Endosseous, Dental Implant |
| Product Code | DZE | DZE | DZE |
| Regulation | 872.3640 | 872.3640 | 872.3640 |
| Intended Use | The S-mini active Fixture is<br>indicated for use in the<br>treatment of missing maxillary<br>lateral incisors or the<br>mandibular central and lateral<br>incisors to serve as temporary<br>support prosthetic devices<br>during the healing phase of<br>permanent endosseous dental<br>implant, such as artificial<br>teeth, in order to restore<br>chewing function in partially<br>edentulous patients. | The S-Mini Implant System<br>divided into two types:<br>Cemented Type<br>-<br>The Cement type is indicated<br>for use in the treatment of<br>missing maxillary lateral<br>incisors or the mandibular<br>central and lateral incisors to<br>serve as temporary support<br>prosthetic devices during the<br>healing phase of permanent<br>endosseous dental implant, such<br>as artificial teeth, in order to | The MS SA Implant(Narrow<br>Ridge) is intended to use in<br>the treatment of missing<br>mandibular central and<br>lateral incisors to support<br>prosthetic device, such as<br>artificial teeth, in order to<br>restore chewing function in<br>partially edentulous patients.<br>The MS SA Implant(Narrow<br>Ridge) is intended for single<br>use only. It is intended for<br>delayed loading |
{5}------------------------------------------------
| | | restore chewing function in partially edentulous patients.<br>- Ball Type<br>The Ball type is designed for use in dental implant surgery.<br>Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only. | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI of ASTM F136 | Pure Titanium of ASTM F67 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: dental implant | Image: dental implant | Image: dental implant |
| Diameters (Ø) | 2.5/3.0/3.5 | 2.0/2.5/3.0/3.5 | 2.5/2.9 |
| Lengths (mm) | 7.0/8.5/10.0/11.5/13.0/15.0 | 7.0/8.5/10.0/11.5/13.0/15.0 | 8.5/10.0/11.5/13.0 |
| Surface<br>Treatment | SLA | RBM | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of<br>Operation | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of the missing teeth as a dental implant fixture. |
| Shelf Life | 5 Years | 5 Years | 5 Years |
# Similarities:
The S-mini active Fixture has same device characteristics with the Primary predicate devices, S-Mini Implant System (K112540) such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar.
The subject device has been supposed to performance and product validations prior to release. Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance.
#### Differences:
The differences between the subject device and the primary predicate device are indications for use, surface treatment and dimensions. The indications for use of the subject and predicates are different because of the removal of ball abutments in the subject device.
The surface treatment method of the subject fixture is SLA (Sandblasted with Large-grit and Acidetching) and the surface treatment method of the primary Predicate device is RBM (Resorbable Blasting Media) To support this discrepancy, K122171 was selected as reference predicate for the fixtures and biocompatibility testing was performed on the subject device. The dimension is slightly different from the predicate devices. However, this dimensional difference doesn't affect device safety and effectiveness.
{6}------------------------------------------------
#### Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-● 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- . Bench testing such as visual test, dimension test, compressive loads, fatigue, adaptation accuracy, and torque tests
- Fatigue Testing according to ISO 14801:2007 under the worst-case scenario
- . Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP <161>, and USP <85>
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K112540.
Fatigue evaluation was performed with the angled abutment of the predicate device under the worstcase scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The SLA surface assessment such as SEM and Chem Analysis was provided in our reference predicate device, K120503 and it is exactly same for the subject device.
Sterilization Validation and Shelf Life testing performed on device with the same raw material, surface treatment method, cleaning condition and packing methods as the the subject device and it demonstrates the sterilization and packing validation safety of the subject device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
#### Conclusion
S-mini active Fixture constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, S-mini active Fixture and its predicates are substantially equivalent.
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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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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Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
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.
What does the AI Performance sub-table show, and why is it useful?
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.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
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Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
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.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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What can you do from the regulations tree view?
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.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
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.
10. Embeddings: the galaxy map
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.
