K162299 · Gp Implants · DZE · Jun 22, 2017 · Dental
Device Facts
Record ID
K162299
Device Name
Spiral Shape Dental Implant System
Applicant
Gp Implants
Product Code
DZE · Dental
Decision Date
Jun 22, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Spiral Shape 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. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Story
Internal hex dental implant system; conical shape; grit-blasted and acid-etched surface. Includes various diameters (3.3-6.0mm) and lengths (8-16mm); includes straight/angled abutments, multiunit abutments, ball attachments, and healing caps. Used by dental surgeons in clinical settings for placement in jaw bone to support prosthetic teeth. Provides structural foundation for dental restoration; enables immediate loading protocols when primary stability is sufficient. Benefits patients by restoring chewing function and oral aesthetics.
Clinical Evidence
Bench testing only. Includes dynamic fatigue testing (ISO 14801), surface analysis (SEM/EDS), sterilization validation (ISO 11137-2, ISO 17665-1/2), package integrity (ASTM F1929-12), accelerated aging (ASTM F1980-07), biocompatibility/cytotoxicity (ISO 10993-5), and endotoxin testing (USP 161).
Technological Characteristics
Material: Ti-6AL-4V ELI (ASTM F136). Design: Conical, internal hex dental implant with grit-blasted/acid-etched surface. Dimensions: 3.3-6.0mm diameter; 8-16mm length. Abutments: Pre-manufactured, max 25° angulation. Sterilization: Validated per ISO 11137-2 (implants) and ISO 17665-1/2 (abutments).
Indications for Use
Indicated for patients requiring surgical and restorative dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Suitable for immediate loading when primary stability and appropriate occlusal loading are achieved.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2017
GP Implants Pivovarov German Beeri 12A Ap7 Netanya ISRAEL
Re: K162299
Trade/Device Name: Spiral Shape Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 19, 2017 Received: May 24, 2017
Dear Pivovarov German:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Pivovarov German
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Andrew I. Steen -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162299
Device Name Spiral Shape Dental Implant System
Indications for Use (Describe)
The Spiral Shape 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.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over - The - Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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### 510k Summary K162299 June 22, 2017 Spiral Shape Dental Implant System
Name and address: GP Implants Beeri 12A, Ap7 Netanya, Israel Contact Person: Pivovarov German Phone Number: +972542079520 Name of device: Spiral Shape Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Product Code: DZE, NHA
Device Description: Spiral Shape Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16 (no 6.0 diameter in 16). Both straight and angled abutments are available.
The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.
Indications for Use: The Spiral Shape 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.
It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Predicate device comparative testing was also provided. Surface analysis according to the FDA guidance document was done including SEM and EDS. Sterilization validation according to ISO 11137-2 was conducted on the implants. Abutment steam sterilization validation was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing according to ASTM F1929-12 and accelerated aging according to ASTM F1980-07 was conducted. Materials used in the product meet ASTM F136 and the biocompatibility was demonstrated by testing the cytotoxicity according to ISO 10993-5. Endotoxin testing according to USP 161 was conducted.
Predicate Device: Alpha-Bio Tec Dental Implant System K063364 Reference Predicate: Ditron Dental Implants K161497
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## Substantial Equivalence:
Spiral Shape Dental Implant System is substantially equivalent to Apha-Bio Tec in indications for use, materials, design, and fatigue performance.
| Company | Spiral Shape Dental Implant System | Alpha-Bio Tec Dental Implant System K063364 (SPI) | Ditron Dental Implants K161497 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Spiral Shape 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.<br>It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The Alpha-Bio Tec 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.<br>SPI implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Ditron's dental implants and abutments are 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. |
| Implant Diameters | 3.3, 3.7, 4.2, 5, 6 | 3.3, 3.75, 4.2, 5, 6 | 3.3 |
| Material of devices included in the submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Type of abutment and maximum angulation | Pre-manufactured of no more than 25° | Pre-manufactured of no more than 25° | Pre-manufactured of no more than 25° |
| Interface type/shape | Internal hex | Internal hex | Internal hex |
| | GP Implants Device | Alpha Bio Tec Device |
|---------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------|
| Spiral Shape Internal<br>Hex Implants | Spiral Shape Implants<br>Diameters of 3.3, 3.7,<br>4.2, 5, and 6mm | SPI Implants<br>Diameters of 3.3, 3.75,<br>4.2, 5, and 6 mm |
| Cover screw | Cover screw | Alpha Bio cover screw |
| Multi-Unit Abutments | Multi-unit abutments in<br>heights of 1,2,3 and 4<br>mm | AlphaLoc Attachment in<br>heights 0.5,<br>1,2,3,4,5,6,and 7mm |
| Ball attachments | Ball attachments in<br>heights of 1,2,3,4,5, and<br>6mm | Ball attachments in<br>heights of 0.5,2,3,4,5,<br>and 6mm |
| Healing Caps 4.5 | Healing cap in 2 and | Standard Healing |
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| diameter | 7mm height | Abutment in heights of<br>2,3,4,5,6, and 7mm |
|------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Healing Caps 5.5<br>diameter | Healing cap in<br>2,3,4,5,6,and 7 | Wide healing abutment<br>in heights of 3 and 5mm |
| Standard Titanium<br>Abutment | Standard Titanium<br>Abutment with height<br>of 7mm | TLA with height of<br>8.5mm |
| Standard Narrow<br>Abutment | Standard narrow<br>abutment with heights<br>of 7,9, and 11mm | TLASP1 Height 8.9<br>TLASP2 Height 9.9<br>TLASP3 Height 10.9<br>TLASP4 Height 11.9 |
| Standard Shoulder<br>Abutment | Standard shoulder<br>abutment in heights of<br>1,2,3 and 4mm | ETLASP1 height 1<br>ETLASP2 height 2<br>ETLASP3 height 3<br>ETLASP4 height 4 |
| Standard Wide<br>Shoulder Abutment | Standard Wide<br>Shoulder Abutment<br>with heights of<br>1,2,3,and 4mm | TLA02 height of 2mm<br>TLA04 height of 4mm |
| Standard 15° Abutment | Standard 15° Abutment<br>with heights of 8, 12,<br>and 13mm | TLA15 height of 8.5mm<br>TLAL15 height of<br>11.5mm |
| Standard 25° Abutment | Standard 25° Abutment<br>with heights of 9 and<br>12mm | TLA25 height of 8.5mm<br>TLAL25 height of<br>11.5mm |
### Conclusion:
Spiral Shape Dental Implant System is substantially equivalent to Alpha-Bio Tec SPI Dental Implant System. They both have the same indications for use, are of the same material, have internal hex and connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing demonstrates substantial equivalence to the identified predicate devices.
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.
