K051909 · Kavo America · NBL · Oct 21, 2005 · Dental
Device Facts
Record ID
K051909
Device Name
DIAGNODENT
Applicant
Kavo America
Product Code
NBL · Dental
Decision Date
Oct 21, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.1745
Device Class
Class 2
Indications for Use
For use as an aid in the diagnosis of dental caries.
Device Story
KaVo DIAGNOdent 2190 is a handheld laser fluorescence device for dental caries detection. It emits 650 nm laser light to illuminate tooth surfaces; detects fluorescence returned from tooth structure; processes signal to provide numeric and audible feedback via integrated LCD screen. Used by dentists in clinical settings to identify carious lesions. Compared to predicate DIAGNOdent 2095, the 2190 features a pen-like form factor with integrated probe, reduced laser power (Class I vs Class II), and single AA battery operation. Output assists clinicians in diagnostic decision-making regarding caries presence and severity.
Clinical Evidence
Substantial equivalence supported by bench, in vitro, and clinical studies, alongside EMC and electrical safety testing. No specific performance metrics (sensitivity/specificity) provided in the summary document.
Technological Characteristics
Laser fluorescence caries detection device. Emits 650 nm laser light (Class I, 190 nw max radiant power). Features integrated probe with sapphire tip. Powered by 1 AA alkaline battery. User interface includes LCD numeric display and audible tones. Sterilization via autoclave for probe tip.
Indications for Use
Indicated for use as an aid in the diagnosis of dental caries in dental office settings.
Regulatory Classification
Identification
A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.
Special Controls
*Classification.* Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.
1. restrictions on the sale, distribution, and use of the device to prescription use in accordance with 21 CFR 801.109;
2. clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
3. labeling that includes detailed use instructions with precautions that urge users to (i) read and understand all directions before using the device, (ii) store probe tips under proper conditions, (iii) properly sterilize the emitter-detector handpiece before each use, and (iv) properly maintain and handle the instrument in the specified manner and condition.
{0}------------------------------------------------
# K051909
## 0CT 2 1 2005
### EXHIBIT 2 510(k) Summary KaVo Dental Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Miller, Director of RA/QA July 11, 2005
- 1. Identification of the Device: Proprietary-Trade Name: KaVo DIAGNOdent® 2190 Classification Name: Dental Hand Instrument, Laser Fluorescence Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device
- 2. Equivalent legally marketed device: DIAGNOdent® 2095, K983658.
- 3. Indications for Use (intended use): For use as an aid in the diagnosis of dental caries.
- 4. Description of the Device: This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.
Image /page/0/Picture/7 description: The image shows two different DIAGNOdent devices. On the left is the Predicate DIAGNOdent 2095, which has a screen and a probe. On the right is the DIAGNOdent 2190, which is a handheld device with a screen. Both devices are used for dental diagnostics.
{1}------------------------------------------------
- 5. Safety and Effectiveness, comparison to predicate device:
| Comparison<br>Areas | DIAGNOdent® 2095,<br>K983658 | DIAGNOdent® 2190 |
|-------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications<br>for use | For use as an aid in the<br>Diagnosis of Dental Caries | SAME |
| Probe<br>technology | Fiber Optic with sapphire<br>tip. | Probe is integrated into<br>the body of the hand held<br>unit, with sapphire tip. |
| Light Source | 655 nm <1 mw Laser | 650 nm, 190 nw<br>maximum average radiant<br>power |
| Laser<br>power<br>class | Class II | Class I |
| Returned<br>light | Fluorescence | Fluorescence |
| Sterilization | Probe tip only, autoclave | SAME |
| User interface | Numeric and audible tones<br>LED numbers | SAME except<br>LCD numbers |
| Power source | 6- AA Alkaline battery | 1- AA Alkaline battery |
| Target<br>population | Dentists' offices | SAME |
- 6. Conclusion: In all important respects, the DIAGNOdent® 2190 is substantially equivalent to the DIAGNOdent® K983658. This conclusion is based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KAVO AMERICA C/O Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deer Field, Illinois 60015
Re: K051909
Trade/Device Name: DIAGNODENT Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence caries detection device Regulatory Class: II Product Code: NBL Dated: October 12, 2005 Received: October 13, 2005
Dear Mr. Kamm:
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 releveloca doors and have be 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 Amendinents, or to arrested Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applicions of the Act. The general controls provisions of the Act include controls provisions of a 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 11 your dovice is classified (See a siditional controls. Existing major regulations affecting (1 writ), it hay be do adjoco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device tan as roublish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
#### Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be auvrsou that 122 a determination that your device complies with other requirements modified in any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bara suirements, including, but not limited to: registration 1 ou must comply with an also 120 cross and 801); good manufacturing practice and houng (21 OF RT rate 001), systems (QS) regulation (21 CFR Part 820); and if requirements us sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your be rinding of substantial equivalence of your device to a premaired predicated. - I a 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), If you desire specific ad riod for your 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Supti y. Michael Oms
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
{4}------------------------------------------------
## Indications for Use
510(k) Number (if known):_K051909
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For use as an aid in the diagnosis of dental caries.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runpe
Suision Sign-Off) Olvision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051105
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.
