(310 days)
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.
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.
The provided text describes a medical device submission (K162299) for the "Spiral Shape Dental Implant System". It details the device's indications for use, its description, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of image analysis, AI, or diagnostic efficacy.
The testing summarized (Dynamic fatigue testing, Surface analysis, Sterilization validation, Package integrity testing, Biocompatibility, Endotoxin testing) are standard engineering and material science tests for dental implants, not performance studies for a diagnostic or AI-driven device.
Therefore, I cannot provide answers to the questions you've posed, as they relate to a type of study and data (e.g., AI performance, expert ground truth, MRMC studies) that are not present in the provided FDA submission document for a dental implant system.
The document primarily focuses on demonstrating that the new dental implant system is substantially equivalent to existing legally marketed predicate devices based on:
- Indications for Use: (described as: "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.")
- Materials: Ti-6AL-4V ELI.
- Design: Conical shape, grit blasted and acid etched surface, internal hex connection, various diameters and lengths.
- Fatigue Performance: Tested according to ISO 14801.
The provided text describes a 510(k) submission for a dental implant system, not a device involving image analysis, AI, or diagnostic performance evaluation with acceptance criteria like sensitivity, specificity, or AUC. Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this document.
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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.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.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 InternalHex Implants | Spiral Shape ImplantsDiameters of 3.3, 3.7,4.2, 5, and 6mm | SPI ImplantsDiameters of 3.3, 3.75,4.2, 5, and 6 mm |
| Cover screw | Cover screw | Alpha Bio cover screw |
| Multi-Unit Abutments | Multi-unit abutments inheights of 1,2,3 and 4mm | AlphaLoc Attachment inheights 0.5,1,2,3,4,5,6,and 7mm |
| Ball attachments | Ball attachments inheights of 1,2,3,4,5, and6mm | Ball attachments inheights of 0.5,2,3,4,5,and 6mm |
| Healing Caps 4.5 | Healing cap in 2 and | Standard Healing |
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| diameter | 7mm height | Abutment in heights of2,3,4,5,6, and 7mm |
|---|---|---|
| Healing Caps 5.5diameter | Healing cap in2,3,4,5,6,and 7 | Wide healing abutmentin heights of 3 and 5mm |
| Standard TitaniumAbutment | Standard TitaniumAbutment with heightof 7mm | TLA with height of8.5mm |
| Standard NarrowAbutment | Standard narrowabutment with heightsof 7,9, and 11mm | TLASP1 Height 8.9TLASP2 Height 9.9TLASP3 Height 10.9TLASP4 Height 11.9 |
| Standard ShoulderAbutment | Standard shoulderabutment in heights of1,2,3 and 4mm | ETLASP1 height 1ETLASP2 height 2ETLASP3 height 3ETLASP4 height 4 |
| Standard WideShoulder Abutment | Standard WideShoulder Abutmentwith heights of1,2,3,and 4mm | TLA02 height of 2mmTLA04 height of 4mm |
| Standard 15° Abutment | Standard 15° Abutmentwith heights of 8, 12,and 13mm | TLA15 height of 8.5mmTLAL15 height of11.5mm |
| Standard 25° Abutment | Standard 25° Abutmentwith heights of 9 and12mm | TLA25 height of 8.5mmTLAL25 height of11.5mm |
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.
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.