(360 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for surgical placement to restore a patient's chewing function, which is a therapeutic purpose.
No
Explanation: The device is an endosseous implant system used for prosthetic attachment to restore chewing function. Its purpose is to provide a physical means for restoration, not to diagnose a condition.
No
The device description clearly details physical components like endosseous implants, cover screws, and healing caps, and the performance studies focus on mechanical testing and biocompatibility of these physical components. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function." This describes a surgical implant used for mechanical support and restoration of function.
- Device Description: The description details the physical characteristics of dental implants, cover screws, and healing caps. These are all physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is implanted into the body.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile.
Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or completely edentulous upper or lower jaws
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)
Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices. Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence.
For the modified implant surfaces, the following information was submitted per FDA Guidance, "Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments: identification of the blast media, composition of the particles, identification of the treatments and agents used to remove the particles, a chemical analysis of the surface and SEM photomicrographs of the surface.
Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence. Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence. The Limulus amebocyte lysate (LAL) test was performed on sterile devices per AAMI ST72 and met the
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2018
Implant Logistics, Inc. % Karen E. Warden, PhD President BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026
Re: K173701
Trade/Device Name: Implant-One™ System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 29, 2018 Received: October 30, 2018
Dear Karen E. Warden, PhD:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Implant-One™ System
Indications for Use (Describe)
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
区 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
510(k) Summary for K173701
| Date: | 28 November 2018 |
|---|---|
| Sponsor: | Implant Logistics, Inc. |
| 305 3rd Street South | |
| Lacrosse, WI 54601 | |
| Phone 608-498-4855 | |
| Sponsor Contact: | Thomas Arendt |
| Trade Name: | Implant-One™ System |
| Common Name: | Dental implant and abutment system |
| Regulatory Class: | Class II |
| Primary Classification | |
| Name, Regulation, | |
| Product Code: | Endosseous dental implant, 21 CFR 872.3640, DZE |
| Secondary Product | |
| Code: | NHA |
| Submission purpose: | To add new components to the system. |
| Device Description: | Endosseous implants are self-tapping and threaded, and offered having root- |
| form or wide thread forms. Root-form implant diameters range from 3.25mm to | |
| 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are | |
| available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm | |
| lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps | |
| provide protection to the threads of the abutment connection during endosseous | |
| and gingival healing. Cover screws are pre- packaged with each implant. | |
| Healing caps are provided as an alternative to the cover screw and are | |
| packaged separately. The Implant-One™ dental implants and cover screws are | |
| provided sterile. | |
| Not all abutments can be used for single-unit restorations. The conical, angled | |
| conical, ball, locator and glueless abutments are intended only for multi-unit | |
| loaded restorations. The ball, locator and glueless abutments are to be used in | |
| fully removable dentures. The conical and angled conical abutments are to be | |
| used in screw retained dentures and with the titanium sleeve for screw retention. | |
| The final design parameters for the custom blank abutment are as follows: | |
| maximum total height, 12.5mm; minimum/maximum gingival height, | |
| 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum | |
| wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, | |
| 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the | |
| 500 Series. | |
| Indications for Use: | The Implant-One™ System is indicated for surgical placement in partially or |
| completely edentulous upper or lower jaws to provide a means for prosthetic | |
| attachment to restore a patient's chewing function. The Implant-One™ system is | |
| indicated for immediate loading only when primary stability is achieved and with | |
| the appropriate occlusal loading. | |
| Materials: | All components (implants, abutments, cover screws, healing caps and abutment |
| screws) are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by | |
| ASTM F136 or wrought titanium alloy (Ti-6Al-4V) as described by ASTM F1472. | |
| Primary Predicate: | Implant-One™ System (Implant Logistics, Inc. – K102822) |
| Reference Devices: | Ankylos C/X Dental Implant System (Dentsply International – K083805), |
| SynCone Abutment 5° (Dentsply International – K131644), Nobel Active® Multi- | |
| unit Abutment (Nobel BioCare® – K072570), Temporary Snap Abutment (Nobel | |
| BioCare® - K161435), ArgenIS Titanium Abutment Blanks (The Argen | |
| Corporation - K143051), LOCATOR® R-Tx Attachment System (K150295 - | |
| Zest Anchors LLC), O-Ring Abutment (K990277 - Biohorizons Implant | |
| Systems), MiNi Internal Implant System (K150537 - Megagen Implant Co, Ltd) |
4
| Performance Data: | Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices. Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence. | ||
|---|---|---|---|
| For the modified implant surfaces, the following information was submitted per FDA Guidance, "Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments: identification of the blast media, composition of the particles, identification of the treatments and agents used to remove the particles, a chemical analysis of the surface and SEM photomicrographs of the surface. | |||
| Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence. Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence. The Limulus amebocyte lysate (LAL) test was performed on sterile devices per AAMI ST72 and met the |