K042707 · Osteotech, Inc. · NUN · Nov 30, 2005 · Dental
Device Facts
Record ID
K042707
Device Name
GRAFTON PLUS DBM PASTE
Applicant
Osteotech, Inc.
Product Code
NUN · Dental
Decision Date
Nov 30, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3930
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
GRAFTON PLUS® DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gans that are . not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
Device Story
GRAFTON PLUS® DBM Paste is a human bone allograft consisting of demineralized bone matrix (DBM) and an inert starch-based additive. Provided as a ready-to-use, malleable paste; manipulated by clinicians to fill dental, oral, and cranio-/maxillofacial bony voids. Used alone or as a bone graft extender mixed with autograft/allograft bone or bone marrow. Implanted into non-load-bearing defects; resorbed and replaced by host bone during healing. Osteoinductive properties validated via ectopic bone formation in athymic rat model.
Clinical Evidence
No human clinical data provided. Evidence consists of bench testing and animal model studies. Osteoinductivity was confirmed using an athymic rat model, demonstrating consistent bone formation.
Technological Characteristics
Human demineralized bone matrix (DBM) combined with an inert starch-based additive. Malleable, ready-to-use paste form. Does not set or harden. Resorbable. No energy source or software components.
Indications for Use
Indicated for patients requiring filling or augmentation of dental intraosseous, oral, and cranio-/maxillofacial bony voids or gaps not intrinsic to structural stability. Applicable to surgically created defects or traumatic injuries, including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, and cystic defects.
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.
PerioGlass Plus-Settable Bone Graft Substitute (K031073)
Submission Summary (Full Text)
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NOV 3 0 2005
K042707
## XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
September 29, 2004
- 1. Submission Applicant & Correspondent:
Name: Address:
Phone No.: Contact Person:
Osteotech. Inc. 51 James Way Eatontown, NJ 07724 (732) 542-2800 Chris Talbot
- 2. Name of Product:
| Trade/Proprietary/Model Name: | GRAFTON PLUS® DBM Paste |
|-------------------------------|-------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Bone Grafting Material |
- 3. Devices to Which New Product is Substantially Equivalent:
Grafton Plus DBM Paste is substantially equivalent, for the purpose of this 510(k), to the following predicate devices.
| Trade/Proprietary/Model Name | Manufacturer | 510(K) # |
|---------------------------------------------------|-------------------------|----------|
| TBM Sponge | Biocoll Laboratories | K960267 |
| PerioGlass-BioGlass Bone<br>Graft Particulate | NovaBone Products, Inc. | K040278 |
| Calcium Hydroxylapatite Implant | BioForm, Inc. | K030682 |
| PerioGlass Plus-Settable Bone<br>Graft Substitute | NovaBone Products, Inc. | K031073 |
In addition, GRAFTON PLUS® DBM Paste is substantially equivalent to human freeze dried bone, such as demineralized bone matrix, to which one or more predicate devices in this device category have claimed substantial equivalence.
- 4. Device Description:
GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.
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GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.
## 5. Intended Use/Indications
GRAFTON PLUS® DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gans that are . not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
- 6. Technical Comparison
GRAFTON PLUS® DBM Paste is substantially equivalent to one or more predicate devices with respect to materials in that it consists of human demineralized bone matrix and an inert non-tissue additive. It is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is implanted in this malleable state and does not set or harden prior to or after implantation.
## 7. Performance Data
Studies of bone formation with GRAFTON PLUS® DBM Paste were conducted using an animal model. These studies demonstrated consistent bone formation with GRAFTON PLUS® DBM Paste.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
Mr. Christopher Talbot Director of Regulatory Affairs Osteotech, Incorporated 51 James Way Eatontown, New Jersey 07724
Re: K042707
Trade/Device Name: GRAFTON PLUS® DBM Paste Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: November 21, 2005 Received: November 22, 2005
Dear Mr. Talbot:
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 - Mr. Talbot
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.
Chiu Lin, Ph.Ď. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K042707
III. Indications for Use - Statement
510(k) Number (if known):
Device Name: GRAFTON PLUS® DBM Paste
Indications for Use:
GRAFTON PLUS®DBM Paste is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON PLUS® DBM Paste may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodeled and replaced by host bone during the healing process.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russoe
on of Anesthesiology, G Control, Control, Dental D
Number: k042707
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
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.
