The Cotec 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 not intended for immediate loading.
Device Story
Cotec Dental Implant System consists of endosseous root-form fixtures and abutments designed for surgical placement into mandible or maxilla bone. Fixtures feature internal or submerged designs with morse tapered connections to facilitate stress distribution and marginal bone preservation. System components are fabricated from CP Titanium (ASTM-F67) or Ti6Al4V ELI (ASTM-F136). Fixtures undergo RBM (Resorbable Blasting Media) surface treatment; abutments remain untreated. Device is used by dental clinicians in clinical settings to support prosthetic restorations. System provides structural foundation for dental replacements, improving patient masticatory function and aesthetics. Not intended for immediate loading.
Clinical Evidence
Bench testing only. Testing included acute systemic toxicity, macroscopic appearance, cytotoxicity, intracutaneous reactivity, pyrogen, sensitization, and sterility testing. All tests met predefined acceptance criteria consistent with FDA guidance for Root-form Endosseous Dental Implants.
Technological Characteristics
Materials: CP Ti Gr 4 (ASTM-F67) for fixtures/cover screws; Ti6Al4V ELI (ASTM-F136) for abutments. Surface treatment: RBM (Resorbable Blasting Media). Connection: Internal morse taper. Fixture diameters: 3.8-5.2mm; lengths: 8-14mm. Sterilization: Gamma radiation for implants; non-sterile for abutments/screws.
Indications for Use
Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Contraindicated for immediate loading.
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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Cotec Dental Implant System
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Cotec Implant Co., Ltd.
# KIDDSII
## 510(K) Summary
JUL - 9 2010
Submitter Cotec Implant Co., Ltd. Choi Ju Won 24-11 A, Sungju-Dong Changwon-City Gyeongnam, 641-120, S. Korea Phone: 88-55-275-9695 Fax: 88-55-289-9695
US Agent / Official Contact Kodent Inc. Joyce Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@gmail.com Phone: 562-404-8466 Fax: 562-404-2757
#### Device Information
Trade Name: Cotec Dental 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: April 30, 2010
### General Description
Cotec Dental Implant System is composed of two types of fixtures, internal and submerged and abutments. The sizes of the fixtures in both internal and submerged type are identical, and made of titanium meta! intended to be surgically placed in the bone of the upper or lower jar arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. This system is made from pure titanium, and the surface treatment of fixtures is done with R.B.M. whereas abutments are not surface treated.
The submerged type implant has an internal morse tapered connection with abutment for stronger engaging and dispersed stress distribution. This means that marginal bone can be perfectly preserved for safety in long term use. There are two types of submerged implant, straight and tapered type. Fixture diameter is Ø3.8, Ø4.2, Ø4.7, Ø5.2mm and the length is 8.0, 10.0, 12.0, 14.0mm. Fixture and cover screw
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are made of CP, Ti, Gr4 (ASTM-F67). The abutment is made of Ti6Al4V,ELI(ASTM-F136), and its diameters are 3.8 - 5.2 mm and the length is 5.5 -- 7.5mm.
#### Indication for Use
The Cotec 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is not intended for immediate loading.
# Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- . SQ IS System (Neobiotech Co., Ltd.; K090825)
- . SQ IT System (Neobiotech Co., Ltd.; K090527)
Testing and other comparisons have established that the subject of Cotec Dental Implant System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.
| | Subject Device | Predicate Device | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 510(K) Number | N / A | K090825 | K090527 |
| Device Name | Cotec Dental Implant System | SQ IS System | SQ IT System |
| Manufacturer | Cotec Implant Co., Ltd. | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Indications for Use | Mandible and Maxilla<br>Endosseous Dental Implant &<br>Accessories | Mandible and Maxilla<br>Endosseous Dental<br>Implant & Accessories | Mandible and Maxilla<br>Endosseous Dental<br>Implant &<br>Accessories |
| Design | Flat shoulder Internal and flat<br>shoulder submerged Implant<br>Design with a narrower shape<br>towards the bottom | Similar to flat shoulder<br>submerged implant<br>design with a narrower<br>shape towards the bottom | Similar to flat<br>shoulder internal<br>implant design with a<br>narrower shape<br>towards the bottom |
| Endosseous Implant Material | CP. Ti. Gr. 4<br>ASTM-F67 | CP. Ti. Gr. 4<br>ASTM-F67 | CP. Ti. Gr. 4<br>ASTM-F67 |
| Implant Sterile | Yes | Yes | Yes : |
| Implant Sterilization Method | Gamma | Gamma | Gamma |
| Abutment and cover screw<br>sterilization method | Non-sterile | Non-sterile | Non-sterile |
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| Surface Treatment | | RBM (Resorbable Blasting<br>Media) | RBM (Resorbable<br>Blasting Media) | RBM (Resorbable<br>Blasting Media) |
|-------------------------|-----------------|-------------------------------------|-------------------------------------|-------------------------------------|
| Implant | Diameters | 3.8 - 5.2 mm | 3.5 - 8.0 mm | 3.5 - 6.0 mm |
| | Lengths | 8 - 14 mm | 7 - 15 mm | 8 - 15 mm |
| Abutment | Diameters | 3.8 - 5.2mm | 3.5 - 8.0mm | 3.5 - 6.0mm |
| | Lengths | 5.5 - 7.5mm | 4.0 - 8.0mm | 4.0 - 8.5mm |
| Cover screw | Diameters | 3.32mm | 3.19 - 3.43mm | 3.5 - 3.6mm |
| | Cuff<br>lengths | 3.0mm | 3.0mm | 3.0mm |
| Attachments | | Various abutments and<br>components | Various abutments and<br>components | Various abutments<br>and components |
| Abutment<br>Material | | Ti6Al4V, ELI,<br>ASTM-F136 | Ti6Al4V, ELI,<br>ASTM-F136 | Ti6Al4V, ELI,<br>ASTM-F136 |
| Cover Screw<br>Material | | CP. Ti. Gr. 4<br>ASTM-F67 | CP. Ti. Gr. 4<br>ASTM-F67 | CP. Ti. Gr. 4<br>ASTM-F67 |
| Product Code | | DZE | DZE | DZE |
#### Performance Data and
We have conducted the following tests. All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutnents, May 12, 2004. The following tests have demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the Cotec Implant System and the referenced predicate devices and it has proved that the Cotec implant system meets its predefined acceptance criteria and performs in accordance with its intended use. Test samples refer to the devices included in this system.
- · Acute systematic toxicity test: This test proved the test samples are safe without having any systematic toxicity.
- · Appearance test: this test conducted by macroscopic examination of external appearance of test samples. No fracture, deformation crack has been found. This test proved the test samples are safe.
- · cytotoxicity test: As a result for this test, the test samples are indicated to be safe to be used.
- · intracutaneous reactivity test : Based on the collected data, this test samples are proved to be safely acceptable rate for intracutaneous reactivity.
- pyrogen test: As a result, this test proved that the test samples are safe with higher than body temperature.
- Sensitization test: In this study, the test samples are proved to be safe with having no indications of erythema or oedema on guinea pig skin.
- · Sterility test: To examine the activity of bacteria, this test has been conducted. As a result, there were no indications of bacterial activity, thus the test samples are proved to be safe to be used.
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#### Safety and Effectiveness
This device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. It has been shown in this 510(k) submission that the differences between the Cotec Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The Cotec Dental Implant system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.
#### Conclusion
The Cotec Dental Implant System, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended. The Cotec Dental Implant System has the same intended use and fundamental scientific technology as its predicate devices - the SQ IS System (K090825) and SQ IT System (K090527) by Neobiotech Co., Ltd. Therefore, Cotec Dental Implant System and its predicate devices are believed to be substantially equivalent.
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Image /page/4/Picture/1 description: The image is a circular seal or logo. The seal contains the symbol of the United States Department of Health and Human Services, which is a stylized eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cotec Implant Company Limited C/O Ms. Joyce Bang Consultant Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670
JUL - 9 2010
Re: K100511
Trade/Device Name: Cotec Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 24, 2010 Received: June 25, 2010
Dear Ms. Bang:
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. Bang
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K100511
Device Name: Cotec Dental Implant System
Indications for Use: The Cotec 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 not intended for immediate loading.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | <img alt="Signature" src="signature.png"/> for NSR |
|----------------------------------------------|----------------------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K100511 |
|----------------|---------|
|----------------|---------|
| | Page 1 of 1 |
|--|-------------|
| | 19 |
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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.
Where do you find a device's intended use without opening the PDF?
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
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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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7. Product codes and the regulations tree
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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.
