The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Story
Alpha-Bio Tec Dental Implant System comprises endosseous dental implants (one/two-stage, internal/external hex, internal octagonal hex), cover screws, healing caps, abutment systems, and surgical instruments. Implants are surgically placed into the upper or lower jawbone to support prosthetic devices (artificial teeth) to restore chewing function. System supports immediate loading protocols when primary stability is achieved. Used in dental clinics by trained dental professionals. Output is a stable foundation for dental prosthetics, benefiting patients by restoring oral function and aesthetics. Device components are manufactured from titanium alloys and stainless steel.
Clinical Evidence
Bench testing only. Compliance with ISO 7405:1997 (biocompatibility), ASTM F136-02a (titanium alloy), ASTM F1350-02 (stainless steel), and ISO 13402:1995 (surgical instruments). No clinical data provided.
Technological Characteristics
Endosseous root-form dental implants. Materials: Titanium-6Aluminum-4Vanadium ELI (ASTM F136-02a) and 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel (ASTM F1350-02). Features internal/external hex and internal octagonal hex connections. Includes one-piece and two-piece systems. Sterilization via standard methods for dental instruments. No software or energy source.
Indications for Use
Indicated for patients requiring dental prosthetic support in the upper or lower jaw. Specific designs (ATID, DFI, SPI, SFB, ATIE OF, ITO, SPR, ARRP, ARPB, ARRC, ARR, ARB, ARS, ARBS) are indicated for surgical and restorative applications, including immediate loading when primary stability is achieved. 3mm diameter implants are restricted to incisors and cuspids of the maxilla and mandible and denture stabilization. Includes temporary or long-term intra-bony applications for fixation of crowns, bridges, and prostheses, and graft site protection.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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KO63364
: 上一篇:
| <span style="float:left">Alpha-Bio Tec 03/06</span> <span style="float:left">RA Department</span> <span style="float:left">FDA Traditional 510k</span> <span style="float:right">Page 105 of 109</span> | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------|--|
| 510(K) SUMMARY | | | |
| Alpha-Bio Tec® Dental Implant System | | | |
| 510(k) Number K | | | |
| A. Applicant's Name: | Alpha-Bio Tec Ltd | | |
| | 7, Embar st. | | |
| | Industrial Zone Kiryat Arie | | |
| | POB 3936 ZIP 49130 | | |
| | Petach-Tikva, Israel | | |
| | Tel: +972-3-9291000 / 9390668 | | |
| | Fax: +972-3-9235055 | | |
| | e-mail: ophir@alpha-bio.net; Daniela@alpha-bio.net | | |
| | Web site: www.alpha-bio.net | | |
| B. Contact Person: | Daniela Ben Shabat | | |
| | Alpha-Bio Tec Ltd | | |
| | 7, Embar st. | | |
| | Industrial Zone Kiryat Arie | | |
| | POB 3936 ZIP 49130 | | |
| | Petach-Tikva, Israel | | |
| | Tel: +972-3-9291000 / 9390668 | | |
| | Fax: +972-3-9235055 | | |
| | e-mail: Daniela@alpha-bio.net | | |
| | Web site: www.alpha-bio.net | | |
| C. Date Prepared: | March 2006 | | |
| D. Trade Name: | Alpha-Bio Tec® | | |
| E. Classification: | | Name: implant, endosseous, root-form | |
| | | Product Code: DZE | |
| | | Regulation No: 872.3640 | |
| | | Class: II | |
| | | Panel: Dental | |
| | | Subsequent Product Code: | |
| | | Name: Abutment, implant, dental, endosseous | |
| | | Product Code: NHA | |
:
Regulation No: 872.3630 Class: II Panel: Dental
···
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Alpha Bio
| Alpha-Bio Tec | 03/06 | RA Department | FDA Traditional 510k | Page 106 of 109 |
|---------------|-------|---------------|----------------------|-----------------|
|---------------|-------|---------------|----------------------|-----------------|
\u05d1\u05e1"\u05d3
- F. Predicate Devices: The Alpha-Bio Tec® is substantially equivalent to 3i® K022009;K022113; Zimmer Tapered screw vent K013227; MIS Implant Technologies Ltd K040807, K003191 ; Biohorizons K041938; K032351; NobelDirect™ K041876; IMTEC K031106 K023067; Branemark K022562, Straumann K033984; K013798; SWISSPLUS IMPLANT CORE VENT CORP K002188 in terms of intended use. indications for use, technological characteristics. performance and user interface.
The predicate device is Class II medical devices.
A discussion of substantial equivalence is provided in Section 3 of this submission.
- G. Device Description: The Alpha-Bio Dental Implant System® consists of one and two stage endosseous form dental implants, internal and external hexagonal; internal octagonal hexagonal; one piece implants system; cover screws and healing caps; abutment systems and superstructures; surgical instruments.
- H. Intended Use / Indication for Use: The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
- I. Performance Standards: No performance standards have been established for such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act.
The device complies with the following recognized standards:
- . ISO 7405:1997, Dentistry - Preclinical Evaluation .
- . of Biocompatibility of Medical Devices Used in Dentistry -Test Methods for Dental
- F136-02a: 2004 Standard Specification for Wrought . Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
- ASTM F1350-02, 2002 Standard Specification for Wrought . 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673).
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| Alpha-Bio Tec | 03/06 |
|---------------|----------------------|
| RA Department | FDA Traditional 510k |
| Page | 107 of 109 |
- ISO 13402:1995, Surgical and dental hand instruments --. Determination of resistance against autoclaving, corrosion and thermal exposure.
- UL 544 (1998):, Standard for Medical and Dental . Equipment - Ed. 4.0.
- J. Substantial Equivalence: There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- · The Alpha-Bio Tec® intended use and indications for use were previously cleared by FDA for the predicate device.
- · The technical characteristics of the Alpha-Bio Tec® are similar to those of the predicate device.
- · Safety and performance testing.
Therefore, the Alpha-Bio Tec® Dental Implant System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
MAR 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha-Bio Tec Limited C/O Mr. Daniel J. Manelli Attornev Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue, NW Suite 440 Washington, DC 20015
Re: K063364
Trade/Device Name: Alpha-Bio Tec® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 9, 2007 Received: March 12, 2007
Dear Mr. Manelli:
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. Manelli
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 vours.
Chiu-Lin, Ph.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
Enclosure
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Amended 3/13/07
Image /page/5/Picture/1 description: The image shows the words "Alpha Bio" in a stylized font. The word "Alpha" is written in a cursive font, while the word "Bio" is written in a more blocky font. The text is black and the background is white. The image appears to be a logo or brand name.
Alpha-Bio Tec 03/06 | RA Department
FDA Traditional 510k Page 109 of 109
## INDICATIONS FOR USE
510(K) Number: K063364
Device Name: Alpha-Bio Tec® Dental Implant System
Indications for Use:
The Alpha-Bio Dental Implant System® is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
Two stage: ATID, DFI, SPI, SFB, ATIE OF, ITO, SPR
One stage: ITO, SPR
One stage and One Piece: ARRP, ARPB, ARRC 3 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible they are also Indicated for denture stabilization using multiple implants
One stage and One Piece for temporary or long-term use: ARR, ARB, ARS, ARBS are self tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosithesis, and protection of graft sites,
DFI, SPI, ARRP, ARPB and ARRC designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SPI and SFB designs are indicated for immediate loading in single tooth restorations when good primary stability is achieved and with appropriate occlusal loading.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evacuation
Susan Runser
.
206334
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
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.
