K043034 · Collagen Matrix, Inc. · NPM · Aug 4, 2005 · Dental
Device Facts
Record ID
K043034
Device Name
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
Applicant
Collagen Matrix, Inc.
Product Code
NPM · Dental
Decision Date
Aug 4, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
OsteoGuide Anorganic Bone Mineral Products are intended for use in dental surgery. The products may be used in surgical procedures such as: Augmentation or reconstructive treatment of alveolar ridge . Filling of periodontal defects Filling of defects after root resection, apicocectomy, and cystectomy . Filling of extraction sockets to enhance preservation of the alveolar ridge . Elevation of maxillary sinus floor . Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) Filling of peri-implant defects in conjunction with products intended for Guided . Bone Regeneration
Device Story
OsteoGuide products are natural, porous bone mineral matrices derived from bovine bone; organic components removed. OsteoGuide Collagen and Blocks variants incorporate purified fibrillar type I collagen. Supplied as sterile, single-use granules or blocks. Used by dental surgeons in clinical settings for bone grafting procedures; provides scaffold for bone regeneration. Acts as osteoconductive material; physically and chemically comparable to human bone mineral. Enhances structural support in dental defects; facilitates healing in conjunction with GTR/GBR membranes.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and effectiveness established via in vitro product characterization and in vitro/in vivo biocompatibility studies.
Technological Characteristics
Natural bovine-derived anorganic bone mineral matrix; optional addition of purified fibrillar type I collagen. Composition meets ASTM F1581-99. Supplied as granules or blocks. Sterile, non-pyrogenic, single-use. Osteoconductive scaffold.
Indications for Use
Indicated for dental surgery patients requiring bone grafting for alveolar ridge augmentation, periodontal defect filling, root resection/apicocectomy/cystectomy defect filling, extraction socket preservation, maxillary sinus floor elevation, or peri-implant defect filling in conjunction with GTR/GBR procedures.
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 4 2005
K043034
#### 510(k) Summary of Safety and Effectiveness
| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: (201) 405-1477<br>Fax: (201) 405-1355 |
| Date of Summary: | February 17, 2005 |
| Device Common Name: | Bone Grafting Material |
| Device Trade Name: | OsteoGuide™ Anorganic Bone Mineral<br>OsteoGuide Collagen™ Anorganic Bone Mineral with<br>Collagen<br>OsteoGuide Blocks™ Anorganic Bone Mineral with<br>Collagen Blocks |
| Device Classification Name: | Bone Grafting Material<br>Unclassified<br>NPM |
| Predicate Device(s): | Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815<br>Bio-Oss® Granules, K952617<br>Bio-Oss® Blocks, K970569<br>Bio-Oss® Collagen, K974399 |
#### Description of the Device
"OsteoGuide™ Anorganic Bone Mineral," "OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen,"and "OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen Blocks" are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the OsteoGuide products is physically and chemically comparable to the mineralized matrix of human bone. The composition of OsteoGuide Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. OsteoGuide Collagen and OsteoGuide Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.
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#### Intended Use
OsteoGuide Anorganic Bone Mineral Products are intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge ●
- . Filling of periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy ●
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . Bone Regeneration
### Summary/Comparison of Technical Characteristics
OsteoGuide Anorganic Bone Mineral Products and their predicates have the same technological characteristics. In particular, the OsteoGuide Anorganic Bone Mineral Products and their predicates are the same with respect to intended use, material, material characterization, form, and sizes.
#### Safety
OsteoGuide Anorganic Bone Mineral Products have been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
#### Effectiveness
The characteristics of the OsteoGuide Anorganic Bone Mineral Products meet the design requirements for an effective bone grafting material.
#### Conclusion
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the OsteoGuide Anorganic Bone Mineral Products are safe and substantially equivalent to Bio-Oss Granules, Bio-Oss Collagen, and Bio-Oss Blocks.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2005
Ms. Peggy Hansen Director, RAC Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K043034
Trade/Device Name: Osteoguide Anorganic Bone Mineral Products Regulation Number: 21 CFR 872.3930 Regulation Name: Tricalcium phosphate granules for dental bone repair Regulatory Class: II Product Code: NPM Dated: July 21, 2005 Received: July 22, 2005
Dear Ms. Hansen:
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 - Ms. Hansen
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,
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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# <043034
## Indications for Use
| 510(k) Number (if known): | |
|---------------------------|------------------------------------------------------------------|
| Device Name: | OsteoGuide™ Anorganic Bone Mineral |
| | OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen |
| | OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen - Blocks |
Indications for Use:
Natural Mineral Bone Graft Substitutes are intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge .
- . Filling of periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy .
- Filling of extraction sockets to enhance preservation of the alveolar ridge .
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided . Bone Regeneration
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)
Siva Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K043034
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.
