(598 days)
No
The summary describes a physical prosthetic component (dental abutment) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a pre-manufactured prosthetic component (abutment) used in dental rehabilitation, not designed to treat a disease or condition itself.
No
Explanation: The device is described as a "pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation." Its function is structural and restorative, not to diagnose a condition.
No
The device description explicitly states it is a "pre-manufactured prosthetic component" and describes physical characteristics like Morse taper, hexagonal male end, and screw retention, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration." This describes a device used in the body for structural support and restoration, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a "pre-manufactured prosthetic component directly connected to the endosseous dental implant." This further reinforces its use as an implantable or directly connected component for dental restoration.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on specimen analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The device described is a dental prosthetic component, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments.
The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations.
Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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)
Mechanical testing of the worst-case Implant-One System construct was performed according to ISO 14801, leveraged from reference device K173701, and showed the Implant-One Multi-Unit Abutment to be substantially equivalent to the primary predicate device. Sterilizations performed according to ISO 17665, leveraged from K173701, were relied upon for the subject devices. Biocompatibility data for the subject abutments were leveraged from reference device K173701. No clinical data were used in support of this submission.
A non-clinical worst-case MRI review was conducted to evaluate the Implant-One™ Multi-Unit Abutment in an MRI environment using scientific evidence and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). Titanium alloy (Ti-6A1-4V, ELI) was assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) by T. O. Woods et al. Based on that rationale, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetic induced displacement force and torque.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
Implant Logistics, Inc. % Floyd Larson President PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K212394
Trade/Device Name: Implant-One™ Multi-Unit Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 15, 2023 Received: February 15, 2023
Dear Floyd Larson:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
Device Name
Implant-One™ Multi-Unit Abutment
Indications for Use (Describe)
The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multiunit restoration.
| 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary K212394 – Implant-One™ Multi-Unit Abutment Implant Logistics, Inc.
March 23, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Implant Logistics, Inc.
711 Spartan Drive
Sparta, WI 54656
(608) 498-4855 (Phone)
(608) 260-7706 (Fax) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Thomas Arendt, President/CEO |
| Representative/Consultant | Floyd G. Larson, MS, MBA
Kevin A. Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
Email: flarson@paxmed.com
kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Implant-One™ Multi-Unit Abutment |
|---|---|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Division | DHT1B: Division of Dental Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K072570, NobelActive Multi Unit Abutment, Nobel Biocare USA, Incorporated
Reference Device K173701, Implant-One™ System, Implant Logistics, Inc
4
INDICATIONS FOR USE STATEMENT
The Implant-One "Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.
SUBJECT DEVICE DESCRIPTION
The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments.
The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations.
Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.
PERFORMANCE DATA
Mechanical testing of the worst-case Implant-One System construct was performed according to ISO 14801, leveraged from reference device K173701, and showed the Implant-One Multi-Unit Abutment to be substantially equivalent to the primary predicate device. Sterilizations performed according to ISO 17665, leveraged from K173701, were relied upon for the subject devices. Biocompatibility data for the subject abutments were leveraged from reference device K173701. No clinical data were used in support of this submission.
A non-clinical worst-case MRI review was conducted to evaluate the Implant-One™ Multi-Unit Abutment in an MRI environment using scientific evidence and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). Titanium alloy (Ti-6A1-4V, ELI) was assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) by T. O. Woods et al. Based on that rationale, we have addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetic induced displacement force and torque.
EQUIVALENCE TO MARKETED DEVICES
The Implant-One Multi-Unit Abutment is substantially equivalent in Indications for Use to NobelActive Multi Unit Abutment (K072570). All are intended for use with endosseous dental implants in the mandible and maxilla to provide prosthetic support.
The subject device IFUS is essentially identical to that of the primary predicate device NobelActive Multi Unit Abutment except for the product names and the explicit statement in the subject device IFUS that it is intended for rehabilitation with a multi-unit restoration.
5
Implant-One Multi-Unit Abutment is substantially equivalent to the primary predicate device NobelActive Multi Unit Abutment in that both are made from the same or similar materials and have similar geometries. The subject device is color anodized for color coding, while the Nobel Active Multi Unit Abutment is not. However, this difference is not significant to substantial equivalence because it is used only to change the thickness of the naturally occurring oxide layer to provide a perception of color (without dyes or additives) and does not affect the material substrate.
Reference device K173701, Implant-One™ System, is included in support of the substantial equivalence comparison of the subject 30° multi-unit abutment, as K173701 included a single-unit 30° abutment that is leveraged for fatigue strength of the subject abutment.
Differences in designs, dimensions or sizes between the subject device and the primary predicate device do not affect substantial equivalence.
The subject device is to be sterilized by the end-user, the same as the primary predicate device K072570. Sterilization validation for the subject device was performed according to ISO 17665-1 and ISO TR 17665-2, leveraged from prior submissions. This sterilization method is the same as that of the primary predicate device K072570.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
6
г
| Indications for Use Statement | |
|---|---|
| Subject Device | |
| Implant-One™ Multi-Unit | |
| Abutment | |
| Implant Logistics, Inc. | The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected |
| to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla | |
| with a multi-unit restoration. | |
| Primary Predicate Device | |
| K072570 | |
| NobelActive Multi Unit | |
| Abutment | |
| Nobel Biocare USA, | |
| Incorporated | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to |
| the endosseous dental implant and is intended for prosthetic rehabilitation. | |
| Reference Device | |
| K173701 | |
| Implant-One™ System | |
| Implant Logistics, Inc | 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. |
Table of Substantial Equivalence Indications for Use Statement
| Comparison | Subject Device | Primary
Predicate Device | Reference Device
(Leveraged for
performance testing) |
|-------------------------------------|--------------------------------------|------------------------------------|-------------------------------------------------------------------------|
| | K212394 | K072570 | K173701 |
| | Implant-One™ Multi-
Unit Abutment | NobelActive Multi
Unit Abutment | Implant-One™ System |
| | Implant Logistics, Inc. | Nobel Biocare
USA, Incorporated | Implant Logistics, Inc. |
| | Image: Subject Device | Image: Primary Predicate Device | Image: Reference Device |
| Prosthetic platform
diameter, mm | 4.8 | 4.8 | NA |
| Cuff heights, mm | 2.5, 3.5 | 1.5, 2.5, 3.5, 4.5 | NA |
| Angulation | 17°, 30° | 17°, 30° | 30° (single-unit abutment
used for worst-case
mechanical testing) |
| Mode of retention | Screw-retained | Screw-retained | Cement-retained |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Surface treatment | Color anodization | None | None |