K011695 · Collagen Matrix, Inc. · NPL · Aug 7, 2001 · Dental
Device Facts
Record ID
K011695
Device Name
COLLAGEN DENTAL MEMBRANE
Applicant
Collagen Matrix, Inc.
Product Code
NPL · Dental
Decision Date
Aug 7, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
Device Story
Collagen Dental Membrane is a resorbable, type I collagen matrix used in oral surgery. It acts as a barrier membrane placed over bone defects, ridges, or dental implants to prevent epithelial down-growth and gingival connective tissue contact with the bone surface, facilitating guided bone regeneration (GBR). The device is provided in two sizes and can be trimmed by the surgeon to fit the specific defect. It is biocompatible, cell-occlusive, and suturable. By isolating the defect site, it allows bone cells to populate the area, promoting integration and firm anchoring of implants. It is intended for use by clinicians in a surgical setting.
Clinical Evidence
No clinical trials were conducted for this specific device. Evidence relies on a comprehensive literature review of resorbable and non-resorbable barrier membranes in animal models and human studies. Animal studies (rat subcutaneous model) confirmed a resorption time of 26-38 weeks. Literature confirms that barrier membranes effectively prevent epithelial down-growth and support bone regeneration in dental implant, ridge augmentation, and bone repair procedures.
Technological Characteristics
Resorbable type I collagen matrix. Designed for guided bone regeneration (GBR). Properties include biocompatibility, cell-occlusivity, and suturability. Dimensions: 20 mm x 30 mm x 40 mm (trimmable). Sterilization method not specified.
Indications for Use
Indicated for patients undergoing oral surgical procedures, including dental implant placement, bone defect repair, or ridge augmentation, to aid in post-surgical wound healing.
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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AUG - 7 2001
K011695
## 510 (k) Summary of Safety And Effectiveness
| Applicant name and address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, NJ 07417 |
|--------------------------------------|--------------------------------------------------------------------------|
| Contact person and telephone number: | Shu-Tung Li, Ph.D.<br>President & CEO<br>Tel: (201) 405-1477 |
| Date of summary: | May 24, 2001 |
| Device generic name: | Collagen Dental Membrane |
| Device trade name: | None |
| Predicate device: | BioGide®,[510(k) #K960724] |
#### Description of the device:
The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo stability, permeability and mechanical strength for use as a material to aid in wound healing in bone repair, ridge augmentation and dental implant procedures.
The device is provided in two sizes 20 mm x 30 mm x 40 mm. The device can be easily trimmed for a final fit during surgery to the appropriate size and shape required for the defect to be treated.
#### Intended Use of the Device
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
#### Technical Characteristics
Collagen Dental Membrane has been designed in accordance with the accepted principles of guided bone regeneration (GBR) as a wound healing material post surgery.
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Specifically, the device is designed to be resorbable, biocompatible, cell occlusive, clinically manageable, and suturable.
#### Summary of Biocompatibility Studies
The Collagen Dental Membrane is biocompatible based on the tests recommended by the FDA.
#### Summary of In Vivo Resorption Studies
In vivo resorption time for the Collagen Dental Membrane was evaluated in a rat subcutaneous implantation model. The results of the studies showed that Collagen Dental Membrane has an in vivo resorption time from 26 to 38 weeks.
#### Summary of Effectiveness Data
#### Animal Data
The concept of "Guided Bone Regeneration (GBR)" in bone repair, ridge augmentation and dental implant surgeries has been proven from animal model studies. That is, during the surgery, a barrier membrane is placed over the bone, ridge or dental implant to retard and/or prevent the down growth of epithelium, and to prevent the contact of gingival connective tissue with the implant and bony surface. Thereby, bone cells can grow into the defect site to fill the defect space or integrate with the dental implant for a firm anchor of the implant within the bone socket.
A comprehensive literature search showed that numerous materials have been studied as a barrier in the GBR studies in various animal models. The animal data provided evidence that the concept of GBR using membranes as a barrier to aid in wound healing has been verified using either resorbable or non-resorbable membranes is a valid approach.
#### b. Summary of Clinical Data
Results from human studies from the literature are consistent with animal studies. Similar to animal studies, the materials studied thus far, resorbable and nonresorbable,
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are both effective as a barrier to aid in wound healing in dental implant, ridge augmentation and bone repair procedures.
# Conclusion
Thus, based on the biocompatibility testing conducted on the Collagen Dental Membrane and literature research on the various membranes, we conclude that the Collagen Dental Membrane is safe for implantation and is effective as a resorbable membrane to aid in wound healing post dental implant, bone repair and ridge augmentation surgeries. The Collagen Dental Membrane is substantially equivalent to BioGide®
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Image /page/3/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 heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Mr. Shu-Tung Li President Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K011695 Trade Name: Collagen Dental Membrane Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: May 30, 2001 Received: May 31, 2001
Dear Mr. Li:
This letter corrects our substantially equivalent letter of August 7, 2001.
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 (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 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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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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sujette y Michie On.D.
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
Image /page/4/Picture/7 description: The image is a black and white circular logo. The logo has the letters "FDA" in large bold font in the center. Above the letters are the numbers "1906 - 2006". The word "Centennial" is written in cursive font below the letters. The text "FOOD AND DRUG ADMINISTRATION" is written around the top of the circle, and the text "IN YOUR SERVICE OF PUBLIC HEALTH" is written around the bottom of the circle.
Protecting and Promoting Public Health
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K011695
510(k) Number (if known):
Collagen Dental Membrane Device Name:
Indications for Use:
Collagen Dental Membrane is intended for use in oral surgical procedures as a resorbable Conagon Dontal Monttin the area of dental implant, bone defect or ridge augmentation to aid in wound healing post surgery.
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Muald W. Sherman for MSR
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devic 510(k) Number _
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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.
