DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K040501 · Musculoskeletal Transplant Foundation · NUN · Apr 29, 2005 · Dental
Device Facts
Record ID
K040501
Device Name
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
Applicant
Musculoskeletal Transplant Foundation
Product Code
NUN · Dental
Decision Date
Apr 29, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
DBX® Demineralized Bone Matrix is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including: Filling of cystic defects Ridge augmentation Filling of extraction sites Sinus lifts Craniofacial augmentation Filling of lesions of periodontal origin Filling of defects of endodontic origin - Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fractures Filling resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall. For dental applications, one or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site. DBX® is osteoconductive and has been shown to be osteoinductive in both validated animal models and a validated in vitro assay. DBX® has not been proven osteoinductive in a human model. DBX® is intended for single patient use only.
Device Story
DBX® is a bone grafting material composed of processed human cortical or corticocancellous bone granules mixed with sodium hyaluronate (NaHA). Available in Paste, Putty, and Mix forms, it serves as an osteoconductive scaffold for bone repair. Used by dentists and oral/maxillofacial surgeons in clinical settings, the material is placed directly into intraosseous defect sites to facilitate bone regeneration. The device is completely resorbable and intended for single-patient use. It provides a physical matrix to support natural bone healing processes in the alveolar ridge and jaw. Clinical benefit is derived from its ability to fill defects and support structural augmentation in dental and maxillofacial procedures.
Clinical Evidence
No clinical data in human subjects provided. Evidence consists of bench testing and biological evaluation, including demonstration of osteoconductivity and osteoinductivity potential in validated animal models (athymic mouse) and validated in vitro assays. It is noted that osteoinductivity in animal/in vitro models has not been proven in human models.
Technological Characteristics
Composed of processed human cortical bone (Paste/Putty) or corticocancellous bone (Mix) combined with sodium hyaluronate (NaHA). Osteoconductive material. Available in five sizes. Completely resorbable. Single-patient use. No electronic or software components.
Indications for Use
Indicated for patients requiring augmentation of deficient maxillary and mandibular alveolar ridges or treatment of oral/maxillofacial and dental intraosseous defects, including cystic defects, extraction sites, sinus lifts, craniofacial augmentation, periodontal/endodontic lesions, traumatic defects (excluding fractures), and resection defects in benign bone tumors/cysts.
Regulatory Classification
Identification
Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Special Controls
*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Koyosol
DBX® Demineralized Bone Matrix
#### 510(k) SUMMARY OF SAFETY & EFFECTIVENESS XI.
DBX® Demineralized Bone Matrix Putty PROPRIETARY NAME: DBX® Demineralized Bone Matrix Paste DBX® Demineralized Bone Matrix Mix COMMON NAME: Bone Grafting Material, Synthetic PROPOSED REGULATORY CLASS: Class II PRODUCT CODE: LYC PANEL CODE: 76 - Dental SPONSOR: Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 732-661-0202
## INDICATIONS FOR USE:
DBX® Putty and Paste are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including:
| Ridge augmentation | Filling of cystic defect |
|---------------------------------------|------------------------------------------|
| Filling of extraction sites | Filling of lesions of periodontal origin |
| Craniofacial augmentation | Filling of defects of endodontic origin |
| Mandibular reconstruction | |
| Repair of osseous defects of the jaws | |
- Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
- Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
DBX® Mix is intended for mandibular reconstruction only.
DBX® is intended for single patient use only.
## DEVICE DESCRIPTION:
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone;
MTF®
CONFIDENTIAL
Page 323 of 326
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the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.
DBX® is osteoconductive and has been shown to have osteoinductivity potential in the athymic mouse model. It is unknown how the osteoinductivity potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.
# PREDICATE DEVICES:
DBX® is substantially equivalent to Geistlich-Pharma's Bio-Oss Anorganic Bovine Bone (K970321), Biomet's 3i Calcium Sodium Phosphate Bone Cement (K003493) and Xomed's Merogel (K001148).
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CONFIDENTIAL
Page 323 of 326
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### Public Health Service
APR 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen M. Laffan Regulatory Submission Specialist Musculoskeletal Transplant Foundation 125 May Street, Suite 300 Edison Corporation Center Edison, New Jersey 08837
Re: K040501
Trade/Device Name: DBX Demineralized Bone Matrix Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: NUN Dated: March 18, 2005 Received: March 21, 2005
Dear Ms. Laffan:
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 ( var 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. Laffan
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,
Suitte H. Michau O ms
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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### INDICATIONS FOR USE STATEMENT IV.
Page 1 of 1
| 510(k<br>Number<br>known<br>- Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childre<br>Concess & Mich Cases Change C<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Device Name:
Indications for Use:
DBX® Demineralized Bone Matrix is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral/maxillofacial and dental intraosseous defects including:
Filling of cystic defects Ridge augmentation Filling of extraction sites Sinus lifts Craniofacial augmentation Filling of lesions of periodontal origin Filling of defects of endodontic origin
- Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fractures
Filling resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
For dental applications, one or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.
DBX® is osteoconductive and has been shown to be osteoinductive in both validated animal models and a validated in vitro assay. DBX® has not been proven osteoinductive in a human model.
DBX® is intended for single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|----------------------|-----------------------------------------------|--------------|----------------------|---------------|
| (Per 21 CFR 801.109) | | | | |
| | Suan Pease | | | |
| | Division Sign-Off) | | | |
| | Division of Anesthesiology, General Hospital, | | | |
| | Infection Control, Dental Devices | | | |
| MTF <sup>®</sup> | | CONFIDENTIAL | K640501 | Page 8 of 377 |
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.
