K073070 · Dio Department Dsi, Inc. · DZE · May 16, 2008 · Dental
Device Facts
Record ID
K073070
Device Name
DIO BIOTITE-H IMPLANT SYSTEM
Applicant
Dio Department Dsi, Inc.
Product Code
DZE · Dental
Decision Date
May 16, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use 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. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.
Device Story
Endosseous dental implant system; screw-form design; used for single or multiple unit prosthetic attachment in upper/lower jaw. Implant consists of machined titanium (ASTM F-67, F-136) with electrochemically deposited calcium phosphate coating (brushite >95%, HA <5%). Surgical placement performed by dental professionals. System includes implants, surgical instruments, and prosthetic components. Provides root-form foundation for fixed or removable prosthetics; restores patient chewing function. Angled abutments on 3.8mm implants limited to anterior region to prevent mechanical failure.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Materials: Commercially pure titanium Gr 3 and Gr 4 (ASTM F-67, ASTM F-136). Surface: 15+/- 5um calcium phosphate coating (brushite >95%, HA <5%) via electrochemical deposition. Design: Screw-form, Morse taper. Diameters: 3.8mm to 5.3mm. Lengths: 8mm to 14mm. Sterilization: Gamma radiation.
Indications for Use
Indicated for patients requiring single or multiple unit prosthetic restoration in the upper or lower jaw arches to restore chewing function. Angled abutments on 3.8mm diameter implants are restricted to the anterior region of the mouth.
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.
HAPSET Hydroxylapatite Bone Graft Plaster (K910432)
Submission Summary (Full Text)
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# K073070
# 510(K) SUMMARY DIO Biotite-H Implant Systems
# MAY 1 6 2008
.
:
-
| | MAY 16 2008 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 15-1. Submitter | DIO Department, DSI, Inc.<br>117 Kyo-Dong, Yangsan-City<br>Kyungnam-Do, 626-210, South Korea<br>Phone: 82-55-363-3401<br>Fax : 82-55-363-3404 |
| 15-2. US Agent /<br>Contact Person | PhD. Steve Chang<br>13340 E. Firestone Blvd. Suite J<br>Santa Fe Springs, CA 90670<br>Phone : 562-404-8466, Fax : 562-404-2757 |
| 15-3. Date Prepared | October 26, 2007 |
| 15-4. Device Name | DIO BIOTITE-H IMPLANT SYSTEMS |
| 15-5. Classification Name | Endosseous Dental Implant System |
| 15-6. Device Classification | Class II<br>Dental Devices panel<br>21 CFR § 872.3640<br>Regulation Number: |
| 15-7. Predicate Devices | IMPLANT INOVATION, INC. (K 955428) |
| 15-8. Performance | Laboratory testing was conducted to determine device functionality<br>and conformance to design input requirements. |
:
1. 1. 1
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#### 15-9. Device Description
The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).
#### 15-10. Packing / Labeling / Product Information
In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. DIO Biotite-H Implant Systems DIO Biotite -H Implant Fixtures will be packaged.
#### 15-11. Intended Use
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use 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. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mount due to possible failure of the implant.
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## 15-12. Substantial Equivalence Comparison
.
The following are the predicate devices that are substantially equivalent to the Calcium Hydroxylapatite Implant:
| K955428 | Implant Innovation, Inc. |
|---------|-----------------------------------------------------------------------|
| | 3i Hydroxylapatite Coated Standard Thread |
| K940348 | OsteoGraft/D-700 |
| | CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228 |
| K882682 | alcitie |
| | Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San Diego, CA 92121 |
| K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 |
| | Coors Biomedical Company, 12860 West Cedar Drive, |
| | Lakewood, CO 80228 |
| K852765 | HA-2000 |
| | Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568 |
| K992416 | Perioglas-BioGlass Bone Graft Particulate |
| | U.S. Biomaterials Corp., One Progress Boulevard, Alachua, |
| | FL 32615 |
| K000149 | Novabone-Bioglass Bone Graft Particulate |
| | U.S. Biomaterials Corp., One Progress Boulevard, Alachua, |
| | FL 32615 |
| K952922 | Biogran Bioactive Glass Synthetic Bone Graft Material |
| | Orthovita Co., 212 Carnegie Center Drive, Suite 206, |
| | Princeton, NJ 08540 |
| K921468 | PermanMesh Hydroxylapatite Matrix |
| | CeraMed Corp., 12860 West Cedar Drive, Lakewood, CO 80228 |
| K862061 | Osteograf/AR+Permaridge Hydroxylapatite, 18-40 |
| | Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228 |
| K910432 | HAPSET Hydroxylapatite Bone Graft Plaster |
| | Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W. |
| | Washington Square, Suite 1100, Washington, D.C. 20036 |
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The Biotite-H Implant is substantially equivalent to the predicate device sited above.
| | Subject Device | Predicate Device |
|---------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIO DENTAL IMPLANT CO. LTD<br>(DIO Biotite-H Implant System) | IMPLANT INOVATION, INC.<br>(K 955428) |
| Intended Use | Identical to predicate devices | The implants are<br>indicated for surgical placement in<br>the upper or lower jaw<br>to provide a means for prosthetic<br>attachment in single tooth<br>restoration and in partially or fully<br>edentulous spans with<br>multiple single teeth, or as a<br>terminal or intermediary<br>abutment for fixed or removable<br>bridgework, and to retain<br>overdentures. |
| Material | Commercially pure titanium GR. 3<br>and GR.4 (ASTM-F-67) | Commercially pure titanium Gr. 3 and<br>Gr.4 (ASTM-F-67) |
| Design | Morse Taper with Thread | Morse Taper with Thread |
| Screw Threads | YES | YES |
| Implant Thread<br>Diameter (mm) | 3.8, 4.1, 4.5, 4.8 and 5.3 mm | 3.8, 4.5, and 5.3 mm |
| Collar Height (mm) | 1.8 | 1.8 |
| Lengths (External) | 8-14 mm | 8-14 mm |
| Surface Treatment | HA Coating | HA Coating |
| Gamma sterilized | YES | YES |
# TECHNOLOGICAL CHARACTERISTIC COMPARISON
## Attachments
| Screw-retained restoration system | YES | YES |
|----------------------------------------|-----|-----|
| Cemented restoration system | YES | YES |
| Overdenture restoration | YES | YES |
| Instruments (surgical and restorative) | YES | YES |
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DIO Department, DSI, Incorporated C/O Dr. Steve Chang Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670
MAY 1 6 2008
Re: K073070
Trade/Device Name: DIO Biotite-H Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 14, 2008 Received: May 16, 2008
Dear Dr. Chang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Chang
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chorts
Chiu Lin. Ph.D. 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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Indication for Use
510(K) Number (if known):
Device Name: DIO Biotite-H Implant System
Indications For Use:
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use 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. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.
Kim Muly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD73070
Prescription Use
(Part 21 CFR 801 Subpart D)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1_
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
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.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
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
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.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
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.
6. Collections
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.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
8. Chart view
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.
