The MII Implant is intended to support single unit or multi-unit restorations in both longterm and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
Device Story
MDI MII 2.9mm is a one-piece endosseous dental implant combining implant and abutment sections; titanium alloy construction. Features include blasted/etched surface for osseointegration, micro-threads at intra-osseous collar for crestal bone preservation, and auto-advancing cutting threads. Prosthetic head options include O-ball and Tapered Abutment; abutment portion coated with Titanium Nitride. Used by dental professionals in clinical settings to support restorations or stabilize dentures. Implant provides mechanical support for prosthetic teeth; immediate loading possible upon achieving primary stability. Benefits include long-term fixation and restoration of dental function.
Clinical Evidence
Bench testing only. Laboratory testing was conducted by the Medical College of Georgia to confirm device functionality and conformance to design input requirements.
Technological Characteristics
One-piece endosseous dental implant; titanium alloy; blasted and etched surface; Titanium Nitride coated abutment; 2.9mm diameter; 10mm-18mm thread lengths; 2mm transgingival collar with platform switching groove; O-ball or Tapered Abutment head designs; auto-advancing cutting threads.
Indications for Use
Indicated for patients requiring single or multi-unit dental restorations or stabilization of upper and lower dentures in edentulous cases; suitable for maxillary and mandibular arches; indicated for immediate loading when primary stability is achieved.
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/19 description: The image shows the logo for IMTEC Corporation. The logo consists of a stylized, abstract graphic to the left of the text "IMTEC". Below "IMTEC" is the word "CORPORATION" in a smaller font size. There is a trademark symbol to the right of the word IMTEC.
K681653
SEP 1 9 2008
## Traditional 510 (k) Premarket Notification
## 510(k) Summary (21 CFR 807.92 (a))
#### 1. Submitter's Information
Name: IMTEC Corporation Address: 2401 N. Commerce IMTEC Plaza Ardmore, OK 73401 Phone: 580-223-4456 Glenn Gee Contact: Date Prepared: 30 May 08
### 2. Device Name
Proprietary Name: MDI MII One-Piece Implant, 2.9mm
Common name:_Dental Implant
Device Classification Name: Endosseous Dental Implant
Regulation No: 872.3640
Class: II
Panel: Dental
- 3. Predicate Device (s):
| Alpha Bio 3.0mm One-Piece Implant | K063364 |
|--------------------------------------------|---------|
| Zimmer® One-Piece Implant, 3.0mm, Straight | K052997 |
| IMTEC Sendax MDI and MDI Plus | K031106 |
| IMTEC Endure Implant System | K030243 |
#### 4. Device Description:
The IMTEC MDI MII 2.9mm one-piece implant is a one piece endosseous dental implant that is a combination of implant and abutment sections. The thread lengths are 10mm, 13mm, 15mm, and 18mm. The implant is composed of Titanium alloy. The MDI MII
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Image /page/1/Picture/1 description: The image shows the logo for IMTEC Corporation. The logo consists of a stylized, abstract shape on the left, resembling a propeller or a stylized letter 'S'. To the right of the shape is the word "IMTEC" in bold, sans-serif font, with the registered trademark symbol. Below "IMTEC" is the word "CORPORATION" in a smaller, sans-serif font.
K081653
body has a thread design for bone compression and the implant tip is equipped with our patent pending auto advancing cutting threads similar to those found on the IMTEC Endure Implant system. The implant section surface is blasted & etched to facilitate osseointegration. In addition, the implant has micro-threads at the intra-osseous collar to preserve crestal bone. It has a transgingival collar 2mm in height that includes a platform switching groove for soft tissue stability. The Implant has two prosthetic head design options, O-ball and Tapered Abutment design. The O-ball head on the MDI MII is identical to the O-ball head on the IMTEC MDI implant. Both are designed for fixed and removable applications. The abutment portion of the MII implant is coated with Titanium Nitride.
#### న. Intended Use:
The MII Implant is intended to support single unit or multi-unit restorations in both longterm and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
#### 6. Comparison of Technological Characteristics
Substantial equivalence of the MDI MII One-Piece implant is based on:
- 1. Design similarities between the proposed MDI MII implant and currently marketed fixtures within the IMTEC MDI Dental Implant System.
- 2. The proposed and currently marketed devices are equivalent in terms of size, materials of construction, performance characteristics, and basic design.
The MDI MI has patent pending, auto advancing, cutting threads, similar to those found on the IMTEC Endure Implant line. The addition to the MDI MII of the auto advancing, cutting threads have no adverse affects on the performance or safety of the IMTEC MDI MII 2.9mm Implant as evaluated in the performance testing conducted by the University of Georgia. The same types of safety and effectiveness characteristics are inherent with each of the devices. The features detailed do not raise new questions related to safety or efficacy of the implant.
The MDI MII implant described in this submission is substantially equivalent to the predicate devices listed and provides the same or similar functions, as well as design and technological characteristics. The intended use, statement of indications, technological characteristics and testing of the IMTEC MDI MII implants support the claim of substantial equivalence.
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Image /page/2/Picture/0 description: The image contains a logo for IMTEC Corporation. The logo features a stylized graphic to the left of the text "IMTEC" in bold, sans-serif font. Below "IMTEC" is the word "CORPORATION" in a smaller, lighter font. The logo is simple and professional in appearance.
There are no unique applications, indications, materials or specifications presented above. Evidence of equivalence has been demonstrated through:
08/653
- IMTEC MDI MII intended use and indications for use were previously cleared by ● the FDA for the various predicate devices listed above.
- The technical characteristics of the IMTEC MDI MII are similar to those of the . predicate device.
- . Safety and performance testing.
Therefore, the IMTEC MDI MII Dental Implant system is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
- 7. Performance Testing
Laboratory testing by the Medical College of Georgia was conducted to confirm device functionality and conformance to design input requirements.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing strokes. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Glenn Gee Regulatory Affairs Manager IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K081653
Trade/Device Name: MDI MII 2.9mm Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 4, 2008 Received: September 8, 2008
Dear Mr. Gee:
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 - Mr. Gee
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 agencics. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
IKAmuele-Rudi,mtr for U
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K08 1653
# Indications for Use
Page / of /
1081
510(k) Number (if known): MDI MII 2.9 mm Implants
Device Name:
Indications for Use:
The MII Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kuano
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081153
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.
