(283 days)
No
The summary describes a dental abutment system and its components, focusing on materials and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The digital design process mentioned refers to standard CAD software, not AI/ML.
No.
This device is an abutment for dental prosthetic rehabilitations, assisting in the placement of restorations on dental implants. It does not directly restore a deficient organ or tissue, nor does it support or sustain life. Its function is primarily structural and supportive for dental prosthetics.
No
Explanation: The device is an abutment for prosthetic rehabilitations, which is a restorative rather than a diagnostic function. Its purpose is to aid in placing prosthetic restorations on dental implants.
No
The device description clearly outlines physical components (Ti-base, prosthetic restoration, basal screw) made from materials like TAN, and mentions manufacturing processes like milling. It also describes physical testing (dynamic fatigue and static strength tests). While digital design is mentioned, the core device is a physical dental abutment system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in prosthetic dental rehabilitations, specifically as an aid in placing dental restorations on implants. This is a mechanical/structural function within the body.
- Device Description: The description details physical components (abutments, screws, restorations) made of materials like TAN and ceramic. These are physical devices for implantation and restoration.
- 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) to provide information for diagnosis, monitoring, or screening.
The device is a dental implant component used for supporting prosthetic restorations, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® Variobase® 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
There are three components to the Straumann® SC Variobase® Abutments:
- Straumann® SC Variobase® Abutments (Ti-base) .
- . Prosthetic restoration (coping and/or crown)
- . Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The prosthetic restoration (the second component of the two-piece abutment) is digitally designed using CAD software and sent to Straumann for manufacture at a validated milling center.
The purpose of this submission is to add the following materials to the previously cleared list of top-half materials for use on the previously cleared Straumann® SC Variobase® Abutments:
- Digital materials: .
- o zerion ML
- o zerion UTML
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)
The following performance data were provided in support of the substantial equivalence determination.
Sterilization Validation
The sterilization process for the Straumann® SC Variobase® Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
The subject devices have the identical sterilization methods compared to the primary and reference predicate devices. No new issues regarding sterilization were raised for the subject devices. Therefore, no additional sterilization validations were required.
Biocompatibility Testing
The subject devices were evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for the subject devices.
The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Bench Testing
Dynamic fatigue and static strength tests were conducted 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" and demonstrated the Straumann® SC Variobase® Abutments are equivalent to the primary predicate devices.
Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® SC Variobase® Abutments are substantially equivalent to the primary predicate and reference devices.
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 logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 5, 2018
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs & Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K173945
Trade/Device Name: Straumann® SC Variobase® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: August 17, 2018 Received: September 5, 2018
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. 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.htm); 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
2
Indications for Use
510(k) Number (if known) K173945
Device Name Straumann® SC Variobase® Abutments
Indications for Use (Describe)
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Straumann® SC Variobase® Abutments
510(k) Summary
K173945 510(k) Summary
Submitter's Contact Information
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Phone Number: 1-978-747-2509
Fax Number: 1-978-747-0023
Contact Person: Jennifer M. Jackson, MS
Date Prepare: October 4, 2018
Name of the Device
| Trade Names: | Straumann® SC Variobase® Abutments |
|---|---|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | §872.3630 |
| Classification: | Class II |
| Product Codes: | NHA |
Predicate Device(s)
Primary Predicate:
K162890 – Straumann® Ø2.9 mm Bone Level Tapered Implant
Reference Devices:
K170356 – Straumann® Variobase® Abutments
Device Description
There are three components to the Straumann® SC Variobase® Abutments:
- Straumann® SC Variobase® Abutments (Ti-base) .
- . Prosthetic restoration (coping and/or crown)
4
Straumann® SC Variobase® Abutments
510(k) Summary
- . Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The prosthetic restoration (the second component of the two-piece abutment) is digitally designed using CAD software and sent to Straumann for manufacture at a validated milling center.
The purpose of this submission is to add the following materials to the previously cleared list of top-half materials for use on the previously cleared Straumann® SC Variobase® Abutments:
- Digital materials: .
- o zerion ML
- o zerion UTML
The following design parameters must be followed when designing the prosthetic restoration in CAD Software:
| zerion ML | zerion UTML | |
|---|---|---|
| Minimum Wall Thickness | 0.4 mm | 0.8 mm |
| Minimum Angulation | 0° | 0° |
| Maximum Angulation | 30° | 30° |
Intended Use
Straumann® SC Variobase® Abutments are intended to be placed into Straumann® Bone Level Tapered Implants Ø2.9 mm to provide support for individual crowns or bridges.
Indications for Use
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the
5
Straumann® SC Variobase® Abutments
510(k) Summary
healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
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.
Technological Characteristics
The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into dental implants to provide support for individual crowns or bridges. The main difference in the technological characteristics between the subject and primary predicate devices is the coping/crown materials. The coping/crown material is identical to the reference predicate device. The technological characteristics of the subject devices are compared to the primary and reference predicates in Table 1.
6
Straumann® SC Variobase® Abutments
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE
PREDICATE DEVICE |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Subject Device | K162890 | K170356 |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Indications for
Use Statement | Straumann® SC Variobase®
abutments are indicated for
use as an aid in prosthetic
rehabilitations. The
prosthetic restoration can
be cemented on the
Straumann® SC Variobase®
prosthetic components. A
temporary restoration can
be used prior to the
insertion of the final
components to maintain,
stabilize and form the soft
tissue during the healing
phase. Final abutments and
restorations may be placed
into occlusion when the
implant is fully
osseointegrated.
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. | Straumann® SC Variobase®
abutments are indicated for
use as an aid in prosthetic
rehabilitations. The
prosthetic restoration can
be cemented on the
Straumann® SC Variobase®
prosthetic components. A
temporary restoration can
be used prior to the
insertion of the final
components to maintain,
stabilize and form the soft
tissue during the healing
phase. Final abutments and
restorations may be placed
into occlusion when the
implant is fully
osseointegrated.
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. | 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. |
| Implant to
Abutment
Connection | Small CrossFit® (SC) | Small CrossFit® (SC) | Narrow CrossFit® (NC)
Regular CrossFit® (RC)
Narrow Neck CrossFit®
(NNC)
Regular Neck (RN)
Wide Neck (WN) |
| Diameter or
Minor Oval
Dimension/
Major Oval
Dimension | 3.3/4.3 mm | 3.3/4.3 mm | Ø3.8 - 7.0 mm |
| Overall
Abutment
Height | 6.7 – 8.7 mm | 6.7 – 8.7 mm | 5.9 - 8.9 mm |
| Coping/ Crown
Material | Digital Workflow:
zerion ML (permanent)
zerion UTML (permanent) | Traditional Workflow:
Type 4 metals (ISO
22674)
IPS e.max® Press
Ceramic
Digital Workflow:
coron® (permanent)
zerion® LT (permanent)
polycon® ae (temporary) | Digital Workflow:
zerion ML (permanent)
zerion UTML (permanent) |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE
PREDICATE DEVICE |
| K Number | Subject Device | K162890 | K170356 |
| Design
Workflow | Wax-up or Open CAD | Wax-up or Open CAD | Wax-up or Open CAD
CARES® Visual |
| Design
Parameters -
Minimum Wall
Thickness | zerion ML - 0.4 mm
zerion UTML – 0.8 mm | zerion® LT – 0.4 mm
coron® - 0.3 mm
polycon® ae - 0.5 mm | zerion ML - 0.4 mm
zerion UTML - 0.8 mm |
| Design
parameters -
Minimum
Angulation | 0° | 0° | 0° |
| Design
Parameters -
Maximum
Angulation | 30° | 30° | 30° |
| Manufacturing
Workflow | Straumann Milling | Traditional casting or
pressing
or
Straumann Milling | Straumann Milling |
| Mode of Action | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained |
7
Straumann® SC Variobase® Abutments
510(k) Summary
Table 1 – Comparison of subject device versus reference device (Straumann® SC
Variobase® Abutments)
Performance Testing
The following performance data were provided in support of the substantial equivalence determination.
Sterilization Validation
The sterilization process for the Straumann® SC Variobase® Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
The subject devices have the identical sterilization methods compared to the primary and reference predicate devices. No new issues regarding sterilization were raised for the subject devices. Therefore, no additional sterilization validations were required.
8
Straumann® SC Variobase® Abutments
510(k) Summary
Biocompatibility Testing
The subject devices were evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for the subject devices.
The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.
Bench Testing
Dynamic fatigue and static strength tests were conducted 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" and demonstrated the Straumann® SC Variobase® Abutments are equivalent to the primary predicate devices.
Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® SC Variobase® Abutments are substantially equivalent to the primary predicate and reference devices.