(119 days)
No
The document describes a dental abutment and its associated components and manufacturing process. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The design process is described as using a "CAD system," which is a standard computer-aided design tool, not necessarily involving AI/ML.
No
The device is described as an intermediary prosthetic component that provides support for customized prosthetic restorations, rather than directly treating or curing a disease or condition.
No
Explanation: The device description clearly states that the Titanium Base Abutment is a prosthetic component used to support customized restorations. Its function is to provide structural support, not to diagnose medical conditions or diseases.
No
The device is a physical dental abutment and its associated superstructures, made of titanium and other materials, intended for placement on dental implants. While digital design is mentioned for the superstructure, the core device is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for customized prosthetic restorations on dental implants. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical component (titanium base abutment) and its associated superstructures, designed for placement within the oral cavity.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on mechanical testing, sterilization, and biocompatibility – all relevant to an implantable or prosthetic device, not an IVD.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).
The Titanium Base abutments are provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). They have a Morse taper implant-to-abutment interface and an additional hexagonal indexing feature at the apical end of the Morse taper connection. The surface is as-machined, without any type of treatment surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K150182 and K150199.
The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.
A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration made of zirconia, IPS e.max CAD or Co-Cr. Each patient-specific superstructure is individually prescribed by the clinician. The minimum wall thickness of the structure is variable depending on the material, according to the table below. The maximum angling of the structure should not exceed 30°. The taper of the structure should not exceed 6°. In the case of a structure angled at the height of the cementable portion starting at the emergence profile (prosthetic height), it should not exceed 10 mm for the Morse Taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis, and dimensional analysis. Testing submitted or referenced in this submission in support of a substantial equivalence determination is as follows:
- Mechanical testing was performed on the Titanium Base abutments including the superstructures according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004
- Ethylene Oxide sterilization validation per ISO 11135
- Steam sterilization validation per the ISO 17665 series standards
- Biocompatibility is supported as the material of the titanium base is identical to the company's own predicate. In addition, the materials for construction of the superstructure are identical to Straumann reference predicates and manufactured at a Straumann validated milling center.
- Clinical data were not submitted in this premarket notification.
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15. 2016
JJGC Indústria e Comércio de Materiais Dentários SA c/o Ms. Jennifer Jackson Head of Quality and Regulatory Straumann USA, LLC 60-100 Minuteman Road Andover, Massachusetts 01810
Re: K153624
Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 15, 2016 Received: March 17, 2016
Dear Ms. Jackson:
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
1
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 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 vours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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 below.
510(k) Number (if known)
Device Name
Neodent Implant System
Indications for Use (Describe)
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
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) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitter | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315
Owner/Operator No.: 9005052 | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | on behalf of: | | |
| | JJGC Indústria e Comércio de Materiais Dentários SA Av. Juscelino
Kubitschek de Olivera, 3291
Curtiba, Parana, BRAZIL 81270-200
Registration No.: 3008261720
Owner/Operator No.: 10031702 | | |
| Contact Person | Jennifer M. Jackson, MS
Head of Quality and Regulatory, Straumann USA
Telephone (978) 747-2509 | | |
| Date Prepared | 15/April/2016 | | |
| Prepared by | Ana Carolina Martins Vianna
Regulatory Affairs Analyst, JJGC Indústria e Comércio de Materiais
Dentários SA
avianna@neodent.com.br | | |
| Product Code | NHA (21 CFR 872.3630) | | |
| Device Class | II (21 CFR 872.3630) | | |
| Classification Panel | Dental | | |
| Classification Name | Endosseous dental implant abutment (21 CFR 872.3630) | | |
| Common Name | Endosseous dental implant abutment | | |
| Proprietary name | Neodent Implant System | | |
| Primary Predicate | K150367 - Neodent Implant System, JJGC Indústria e Comércio de
Materiais Dentários SA | | |
| Reference Predicates | K120822 - Straumann® CARES® Variobase™ Abutments, Institu
Straumann AG
K142890 - Straumann® CARES® Variobase™ Abutments, Institut
Straumann AG | | |
Device Description
This submission includes the Titanium Base abutments (two-piece hybrid abutments) and the superstructures that compose the final abutment (the second part of the two-piece abutment).
The Titanium Base abutments are provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). They have a Morse taper implant-to-abutment interface and an additional hexagonal indexing feature at the apical end of the Morse taper connection. The surface is as-machined, without any type of treatment
4
surface. The Titanium Base abutment is an intermediary prosthetic component between the implant and prosthesis; a CAD/CAM abutment design to be used as a base when fabricating a coping, crown or bridge superstructure. It is a stock abutment, previously cleared per K150367. The subject abutments are compatible with Neodent dental implants having Morse taper (CM) implant-to-interface cleared under K101945, K123022, K133592, K150182 and K150199.
The purpose of this submission is to expand the range of materials allowed in fabricating the superstructure, adding Co-Cr and IPS e.max "CAD materials to the previously cleared portfolio.
A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration made of zirconia, IPS e.max CAD or Co-Cr. Each patient-specific superstructure is individually prescribed by the clinician. The minimum wall thickness of the structure is variable depending on the material, according to the table below. The maximum angling of the structure should not exceed 30°. The taper of the structure should not exceed 6°. In the case of a structure angled at the height of the cementable portion starting at the emergence profile (prosthetic height), it should not exceed 10 mm for the Morse Taper.
| Material | Minimum thickness (mm) |
|---|---|
| CoCr | 0.3 |
| Zirconia | 0.5 |
| IPS e.max | 0.6 |
The planning of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Technological Characteristics
The Titanium Base abutment is a two-piece abutment consisting of a pre-manufactured (stock) abutment made of titanium alloy conforming to ASTM F136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), and a customized superstructure made of ceramics (zirconia or IPS e.max CAD) or Co-Cr. A dental laboratory equipped with an appropriate CAD system, will design a customized superstructure or restoration, which must be milled at a Straumann validated milling center.
The following table shows a comparison among the features of subject device and its predicate and reference devices. The assessment of the differences is also included.
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| SUBJECT DEVICE | PRIMARY PREDICATE | ||
|---|---|---|---|
| Neodent Implant System | Neodent Implant System | ||
| (K150367) | EQUIVALENCE DISCUSSION | ||
| Indications for Use | Titanium Base Abutment is a titanium base | ||
| placed onto Neodent dental implants to | |||
| provide support for customized prosthetic | |||
| restorations. It is used with a coping and | |||
| crown, or crown alone, and is indicated for | |||
| cement-retained single or multi-unit | |||
| restorations, or screw-retained single | |||
| restorations. | |||
| All digitally designed copings and/or | |||
| crowns for use with the Neodent Titanium | |||
| Base Abutment System are intended to be | |||
| sent to Straumann for manufacture at a | |||
| validated milling center. | Titanium Base Abutment is a titanium base | ||
| placed onto Neodent dental implants to | |||
| provide support for customized prosthetic | |||
| restorations. It is used with a coping and | |||
| crown, or crown alone, and is indicated for | |||
| cement-retained single or multi-unit | |||
| restorations, or screw-retained single | |||
| restorations. | Equivalent | ||
| The basic indication of providing support | |||
| for prostheses is identical. Additional | |||
| wording was added to the indications to | |||
| support the titanium base abutments | |||
| manufacturing process. The subject | |||
| device and primary predicate have | |||
| slightly different Indications for Use | |||
| language. However, the difference in | |||
| language does not change the intended | |||
| use or substantial equivalence. | |||
| Abutment Diameter(s) | 3.5 and 4.5 mm | 3.5 and 4.5 mm | Identical |
| Implant-to-Abutment | |||
| Connection | Morse taper (CM) interface | Morse taper (CM) interface | Identical |
| Compatibility | Morse taper (CM) implant lines of Neodent | ||
| Implant System. | Morse taper (CM) implant lines of Neodent | ||
| Implant System. | Identical | ||
| Mode of attachment | Screw-retained or cement | ||
| retained | Screw-retained or cement | ||
| retained | Identical | ||
| Restoration | |||
| Angulation(s) | Up to 30° | Up to 30° | Identical |
| Gingival Height(s) | 0.8, 1.5, 2.5, 3.5 and 4.5mm | 0.8, 1.5, 2.5, 3.5 and 4.5mm | Identical |
| Material of abutment | Titanium-aluminum-vanadium alloy Ti-6Al- | ||
| 4V | Titanium-aluminum-vanadium alloy Ti-6Al- | ||
| 4V | Identical |
6
| SUBJECT DEVICE | PRIMARY PREDICATE | EQUIVALENCE DISCUSSION | |
|---|---|---|---|
| Neodent Implant System | Neodent Implant System | ||
| (K150367) | |||
| Material of | |||
| superstructure | Zirconia | ||
| Co-Cr | |||
| IPS e-max CAD | Zirconia | Equivalent |
Addition of IPS e.max CAD and CoCr
materials does not change the Indications
For Use. These materials are used widely
for dental restorations, including with the
Straumann Variobase devices identified as
reference devices to this submission. |
| Sterility | Delivered sterile by EO exposure. To be
sterilized by user after the coping
cementation, before placed in patient
mouth. | Delivered sterile by EO exposure. To be
sterilized by user after the coping
cementation, before placed in patient
mouth. | Identical |
| Sterilization by end
user | Moist steam sterilization | Moist steam sterilization | Identical |
7
Performance data
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis, and dimensional analysis. Testing submitted or referenced in this submission in support of a substantial equivalence determination is as follows:
- . Mechanical testing was performed on the Titanium Base abutments including the superstructures according to ISO 14801 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and FDA document Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004
- . Ethylene Oxide sterilization validation per ISO 11135
- . Steam sterilization validation per the ISO 17665 series standards
- . Biocompatibility is supported as the material of the titanium base is identical to the company's own predicate. In addition, the materials for construction of the superstructure are identical to Straumann reference predicates and manufactured at a Straumann validated milling center.
- . Clinical data were not submitted in this premarket notification.
Conclusions
Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices and do not raise new issues of safety and effectiveness when uses as labeled.