BIO-OSS®, BIO-OSS Blocks and BIO-OSS® Collagen are recommended for: . Filling of large oral and maxillofacial intra-osseous cavities
Device Story
BIO-OSS, BIO-OSS Blocks, and BIO-OSS Collagen are natural, non-antigenic, porous bone mineral matrixes derived from bovine bone via removal of organic components. Physically and chemically comparable to human bone mineralized matrix. Available as cortical granules and blocks. Used by clinicians in oral and maxillofacial surgery to fill intra-osseous cavities, periodontal defects, extraction sockets, and peri-implant defects, or for sinus floor elevation. Acts as a scaffold for bone regeneration. The device is identical to previously cleared versions, with the only change being the addition of Australia as an alternative geographic source for bovine bone, supported by a risk assessment regarding BSE-risk.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on the chemical and physical comparability to previously cleared predicate devices and a risk assessment regarding the alternative bovine bone source.
Technological Characteristics
Natural, non-antigenic, porous bovine bone mineral matrix. Available as cortical granules and blocks. Chemically and physically comparable to human bone mineralized matrix. No electronic components, software, or energy sources.
Indications for Use
Indicated for augmentation or reconstructive treatment of alveolar ridge; filling of periodontal defects; filling of defects after root resection, apicoectomy, and cystectomy; filling of extraction sockets for alveolar ridge preservation; elevation of maxillary sinus floor; filling of periodontal defects with GTR/GBR products; and filling of peri-implant defects with GBR products.
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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JAN 1 5 2004
## 510(k) Summary
K033815
## BIO-OSS®
## BIO-OSS® Blocks
## BIO-OSS® Collagen
#### 1. SPONSOR
Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhuscn SWITZERLAND
Contact Person: Dr. Susana Wäsch, 011-41-41-49-25-630 Date Prepared: December 5, 2003
#### 2. DEVICE NAME
| Proprietary Name: | BIO-OSS®, BIO-OSS® Blocks, BIO-OSS® Collagen |
|----------------------|----------------------------------------------|
| Common/Usual Name: | Anorganic Bovine Bone Filling Material |
| Classification Name: | Bone Filling Material |
#### 3. PREDICATE DEVICES
BIO-OSS® (K871773, K952617, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS® Collagen (K974399)
#### 4. INTENDED USE
BIO-OSS®, BIO-OSS Blocks and BIO-OSS® Collagen are recommended for:
- . Filling of large oral and maxillofacial intra-osseous cavities
#### ડ. DEVICE DESCRIPTION
BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.
#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE
BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are substantially equivalent to Geistlich's existing products, BIO-OSS® Anorganic Bovine Bone (K871773, K952617, and K970321), BIO-OSS® Blocks (K920508, K952618, and K970569), and BIO-OSS®
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Collagen (K974399). The only difference between the new products and the products previously cleared is that an alternative geographic source for the bovine bone is proposed to be added - Australia. The current source of bone is the United States. The European Union, in its Report on the Assessment of the Geographical BSE-risk of Australia, found Australia to have a level I Geographical BSE-risk ("GBR") - which means that it is highly unlikely that there is the presence of one or more cattle clinically or pre-clinically infected with the BSE agent in Australia. The United States has a level II GBR. It should be noted that Australia is not on the U.S. Department of Agriculture's list of countries affected with BSE. See 9 C.F.R. § 94.18. The company has performed a Risk Assessment per FDA Guidance to address traceability and pedigree of the herds. Therefore, using an alternative source of bovine bone will not negatively impact the products' safety or effectiveness.
With regard to the safety and effectiveness of the anorganic bovine bone used in BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen Geistlich incorporates by reference all of the information on the use of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen in the above referenced 510(k) submissions.
BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen, as proposed to be sourced are substantially equivalent to the existing BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen products, in substance, function and intended use.
Based on the forcgoing, Geistlich believes that the information and data herein submitted demonstrates not only that these versions of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen arc substantially equivalent to existing BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen products but also that these products have been shown to be safe and effective for the labeled indications.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# JAN 1 5 2004
Geistlich-Pharma Ag C/O Mr. Peter S. Reichertz Sonnenschein Nath & Rosenthall LLP 1301 K Street NW Suite 600, East Tower Washington, D.C. 20005
Re: K033815
Trade/Device Name: BIO-OSS Granules, BIO-OSS Blocks and BIO-OSS Collagen Regulation Number: None Regulation Name: Nonc Regulatory Class: Unclassified Product Code: NPM Dated: December 8, 2003 Received: December 12, 2003
Dear Mr. Reichertz:
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 r mondinely of od, 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 Eederal Register.
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Page 2 – Mr. Reichertz
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 (301) 594-4613. 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 maj country 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/dsma/dsmamain.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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K033815
## Indications for Use
510(k) Number (if known): K033815
Device Name: BIO-OSS Granules, BIO-OSS Blocks and BIO-OSS Collagen
Indications for Use:
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing 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 Regencration (GTR) and Guided Bone Regencration (GBR).
Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Over-The-Counter Use レ Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runge
Page 1 of
ivision Sign-Off) vision Sign-Olf/
vision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
25103438\V-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.
