(310 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to restore a patient's chewing function and supports prosthetic devices, which are clear therapeutic applications.
No
Explanation: The device is a dental implant system designed for surgical and restorative applications to replace teeth. Its purpose is to physically support prosthetic devices, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components like implants, abutments, and healing caps, and the performance studies involve physical testing (fatigue, surface analysis, sterilization, etc.), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states that the Spiral Shape Dental Implant System is a physical device intended for surgical implantation into the bone of the jaw to support prosthetic devices. It is used within the body to restore function.
The information provided about the device's intended use, description, and performance studies all relate to a surgically implanted medical device, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
3
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
4
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 Internal | ||
| Hex Implants | Spiral Shape Implants | |
| Diameters of 3.3, 3.7, | ||
| 4.2, 5, and 6mm | SPI Implants | |
| Diameters 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 in | |
| heights of 1,2,3 and 4 | ||
| mm | AlphaLoc Attachment in | |
| heights 0.5, | ||
| 1,2,3,4,5,6,and 7mm | ||
| Ball attachments | Ball attachments in | |
| heights of 1,2,3,4,5, and | ||
| 6mm | Ball attachments in | |
| heights of 0.5,2,3,4,5, | ||
| and 6mm | ||
| Healing Caps 4.5 | Healing cap in 2 and | Standard Healing |
5
| diameter | 7mm height | Abutment in heights of
2,3,4,5,6, and 7mm |
|------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Healing Caps 5.5
diameter | Healing cap in
2,3,4,5,6,and 7 | Wide healing abutment
in heights of 3 and 5mm |
| Standard Titanium
Abutment | Standard Titanium
Abutment with height
of 7mm | TLA with height of
8.5mm |
| Standard Narrow
Abutment | Standard narrow
abutment with heights
of 7,9, and 11mm | TLASP1 Height 8.9
TLASP2 Height 9.9
TLASP3 Height 10.9
TLASP4 Height 11.9 |
| Standard Shoulder
Abutment | Standard shoulder
abutment in heights of
1,2,3 and 4mm | ETLASP1 height 1
ETLASP2 height 2
ETLASP3 height 3
ETLASP4 height 4 |
| Standard Wide
Shoulder Abutment | Standard Wide
Shoulder Abutment
with heights of
1,2,3,and 4mm | TLA02 height of 2mm
TLA04 height of 4mm |
| Standard 15° Abutment | Standard 15° Abutment
with heights of 8, 12,
and 13mm | TLA15 height of 8.5mm
TLAL15 height of
11.5mm |
| Standard 25° Abutment | Standard 25° Abutment
with heights of 9 and
12mm | TLA25 height of 8.5mm
TLAL25 height of
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.