(121 days)
No
The document describes a physical dental abutment and the materials used for the prosthetic restoration. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation mentioned is for general software principles, not specifically AI/ML.
No.
The device, a dental abutment, provides mechanical support for prosthetic restorations and is not described as having any therapeutic function for treating or preventing disease.
No
This device is a dental abutment system and associated materials used for creating prosthetic restorations, providing structural support to customized prosthetics attached to dental implants. It is not used for diagnosing medical conditions.
No
The device is a physical dental abutment and associated materials, not a software-only device. While software is used in the design and manufacturing process, the device itself is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental abutment placed onto dental implants to support prosthetic restorations. This is a mechanical function within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces that it's a physical component used in dental prosthetics.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a dental prosthetic component, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes
NHA
Device Description
The purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis.
The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.
Materials:
- Straumann Variobase Abutments: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The Straumann® Variobase™ Abutments are identical to the Straumann predicates (K142890).
- Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw components of the Straumann® Variobase™ Abutments are identical to the basal screw components of the Straumann predicates (K142890).
- Coping, Crown or Bridge: zerion® ML Zirconia and zerion® UTML Zirconia ceramic materials.
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)
Bench testing was performed to evaluate the performance of the proposed Straumann® Variobase™ Abutments.
• Dynamic fatigue tests were conducted in according to the FDA guidance document “Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments”.
• Steam sterilization validation per FDA guidance entitled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling dated March 17, 2015 and the ISO 17665 series standards.
• Cytotoxicity per ISO 10993-5
• Inorganic extractables/leachables per ISO 10993-18
• Software validation per FDA guidance document: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on: January 11, 2002 and per IEC 62304.
No animal or human clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K050160, K131534, K143439, K120822, K151324
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The outer ring of the logo contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the ring is a symbol consisting of three stylized human profiles facing to the right. The profiles are connected and appear to be layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K170356
Trade/Device Name: Straumann® Variobase® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8, 2017 Received: May 9, 2017
Dear Jennifer 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 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
1
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 (QS) 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.
Lori A. Wiggins -S6
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
2
Indications for Use
510(k) Number (if known)
Device Name
Straumann® Variobase® Abutments
Indications for Use (Describe)
The Straumann® Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® 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)
X 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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 | K170356 |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) |
| 60 Minuteman Road | |
| Andover, MA 01810 | |
| Contact Person: | Jennifer M. Jackson, MS |
| Director of Regulatory Affairs and Quality | |
| +1 (978) 747-2509 | |
| Prepared By & | |
| Secondary Contact: | Christopher Klaczyk |
| Head of Regulatory Affairs & Compliance | |
| Institut Straumann AG | |
| +41 61 965 1260 | |
| Date Prepared: | June 01, 2017 |
| Product Code(s): | 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: | Straumann® Variobase® Abutments |
| Predicate Device(s): | K142890, Straumann Variobase Abutments (Institut |
| Straumann) | |
| Reference Device(s): | K050160, Katana Zirconia (Noritake Company) |
| K131534, KATANA Zirconia (Kuraray Noritake Dental) | |
| K143439, KATANA Zirconia (Kuraray Noritake Dental) | |
| K120822, CARES Variobase Abutments (Institut Straumann) | |
| K151324, Variobase for CEREC (Institut Straumann) | |
| Device Description: | The purpose of the subject submission is to add the zerion® ML |
| and zerion® UTML Zirconia ceramic materials as a material | |
| suitable for fabrication of the coping, crown or bridge that, | |
| when bonded to the previously cleared Variobase abutment | |
| base (K120822, K142890), forms a finished dental prosthesis. |
4
The Straumann Variobase Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann Variobase Abutments are available to fit Straumann dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The restoration will be manufactured via validated Straumann milling.
Image /page/4/Figure/2 description: The image shows a dental implant device. The device consists of a basal screw, a prosthetic restoration (full contour crown), and a Straumann Variobase Abutment. The image shows the device in two different views, one in cross-section and one in full view.
Indications For Use: The Straumann Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Materials:
- · Straumann Variobase Abutments: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The Straumann® Variobase™ Abutments are identical to the Straumann predicates (K142890).
- Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw components of the Straumann® Variobase™ Abutments are identical to the basal screw components of the Straumann predicates (K142890).
- · Coping, Crown or Bridge: zerion® ML Zirconia and zerion® UTML Zirconia ceramic materials.
5
| Technological
Characteristics: | A comparison of the relevant technological characteristics
between the subject and primary predicate devices is provided
in the table that follows. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The material used in the manufacture of Straumann Variobase
Abutments is a titanium-aluminum-niobium alloy which meets
the requirements of ISO 5832-11. Bench testing was performed
to evaluate the performance of the proposed Straumann®
Variobase™ Abutments.
• Dynamic fatigue tests were conducted in according to the
FDA guidance document “Guidance for Industry and FDA
Staff – Class II Special Controls Guidance Document: Root-
form Endosseous Dental Implants and Endosseous Dental
Abutments”.
• Steam sterilization validation per FDA guidance entitled
Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling dated March 17, 2015 and
the ISO 17665 series standards.
• Cytotoxicity per ISO 10993-5
• Inorganic extractables/leachables per ISO 10993-18
• Software validation per FDA guidance document: General
Principles of Software Validation; Final Guidance for
Industry and FDA Staff, issued on: January 11, 2002 and per
IEC 62304.
No animal or human clinical studies were conducted. |
| 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. |
6
| Feature | SUBJECT Devices
Straumann Variobase Abutments | Primary PREDICATE Device
Straumann Variobase Abutments
(K142890) | Equivalence Discussion |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Straumann® Variobase™ Abutment is a
titanium base placed onto Straumann dental
implants to provide support for customized
prosthetic restorations. Straumann®
Variobase™ Abutments are indicated for
screw-retained single tooth or cement-
retained single tooth and bridge
restorations. | The Straumann® Variobase™ Abutment is a
titanium base placed onto Straumann dental
implants to provide support for customized
prosthetic restorations. Straumann®
Variobase™ Abutments are indicated for
screw-retained single tooth or cement-
retained single tooth and bridge
restorations. | Identical |
| Ti-base
Material | Titanium-Aluminum-Niobium alloy
(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy
(Ti-6Al-7Nb) | Identical |
| Abutment
Diameter | 3.8 - 7.0 mm | 3.8 – 7.0 mm | Identical |
| Abutment Height | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Identical |
| Max. Angulation | 30° | 30° | Identical |
| Coping/ Crown
Material | zerion® ML zirconia ceramic and zerion®
UTML zirconia ceramic are being added to
the previously cleared coping/crown
materials | Traditional Workflow:
Type 4 Metals (ISO 22674)
IPS e.max® Press Ceramic
Digital Workflow:
polycon® ae (temporary)
zerion® (permanent)
IPS e.max® CAD Ceramic (permanent)
coron® (permanent) | Equivalent
The digital workflow is being expanded to
add additional materials, zerion® ML &
UTML zirconia ceramics.
zerion® ML & UTML zirconia ceramics are
substantially equivalent to the previously
cleared zerion® HT zirconia ceramics |
| Design Workflow | Wax-up or CAD | Wax-up or CAD | Identical |
| Feature | SUBJECT Devices
Straumann Variobase Abutments | Primary PREDICATE Device
Straumann Variobase Abutments
(K142890) | Equivalence Discussion |
| Manufacturing
Workflow | Straumann Milling | Traditional casting or pressing
or
Straumann Milling | Identical |
| Mode of
Attachment | Screw-retained or cement retained | Screw-retained or cement retained | Identical |
| Reusable | No | No | Identical |
7