(96 days)
No
The document describes a physical dental abutment and its intended use in prosthetic rehabilitations. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The manufacturing process is described as traditional or CAD/CAM, which does not inherently imply AI/ML.
No.
The device is a prosthetic component that supports dental restorations, not a device directly used for treatment of a disease or condition.
No
This device is a prosthetic component (abutment) used to support dental restorations, not to diagnose a condition.
No
The device description explicitly states the device is made from Ti-6Al-7Nb (TAN) and includes a basal screw, indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Straumann® Variobase™ prosthetic components are physical devices intended to be directly connected to dental implants within the patient's mouth to support prosthetic restorations. They are used in the process of dental rehabilitation, not for analyzing biological samples.
- Intended Use: The intended use clearly describes the device's role in supporting prosthetic reconstructions on dental implants.
- Device Description: The description details the material and function of the abutments and screws, which are physical components for mechanical support.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Straumann® Variobase™ prosthetic components fall under the category of a medical device used in dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.
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 studies. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission.
The subject devices are substantially equivalent to the identified predicate devices based on design and applicable performance data.
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.
K132219, K120822, K080239, K990342, K140737
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/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2015
Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810
Re: K151157
Trade/Device Name: Straumann® Variobase® Abutment for Bars/bridges Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 2, 2015 Received: July 6, 2015
Dear Mr. Klaczyk:
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.
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 (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 yours,
Tina
Kiang-S
for 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
Indications for Use
510(k) Number (if known) K151157
Device Name
Straumann® Variobase Abutments for Bridges/Bars
Indications for Use (Describe)
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
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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K151157
510(k) Summary
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315
Owner/Operator No.: 9005052 | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Christopher Klaczyk
Director of Regulatory Affairs and Clinical Research | | |
| Date Prepared: | August 4, 2015 | | |
| Product Code(s): | NHA (21 CFR 872.3630) | | |
| Device Class: | II
(21 CFR 872.3630) | | |
| Classification Panel: | Dental | | |
| Classification Name: | Endosseous dental abutment (21 CFR 872.3630) | | |
| Proprietary Name: | Straumann® Variobase® Abutment for Bridges/Bars | | |
| Predicate Device(s): | • K142890, Straumann Variobase Abutments | | |
| Reference Device(s): | • K132219, Straumann Variobase Abutments
• K120822, Straumann CARES Variobase Abutment NNC,
RN, WN, NC, RC
• K080239, Straumann Bone Level Multibase Abutments
• K990342, Straumann synOcta Prosthetics
• K140737, Straumann Screw-Retained Bridge and Bar | | |
| Device Description: | The Straumann Variobase Abutments for Bars & Bridges are
non-engaging abutments made from Ti-6Al-7Nb (TAN) that
support a bridge or bar reconstruction (framework or full
contour) on two or more dental implants. The corresponding
basal screw is delivered with the abutment for connecting the
abutment to the implant. A dental laboratory technician designs
and manufactures the bridge/bar reconstruction via their
preferred workflow using traditional or CAD/CAM methods. | | |
4
| Indications For Use: | Straumann® Variobase® prosthetic components directly
connected to the endosseous dental implants are indicated for
use as an aid in prosthetic rehabilitations. The prosthetic
restoration (bridge or overdenture) can be cemented on the
Straumann® 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. They may not be placed into
occlusion. Final abutments and restorations may be placed into
occlusion when the implant is fully osseointegrated. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Straumann® Variobase® abutments are intended to be placed
into Straumann dental implants to provide support for prosthetic
reconstructions such as bridges and over-dentures. |
| Materials: | The subject devices are produced from titanium-6aluminum-
7niobium alloy (TAN). This is the same material as for the
predicate devices cleared to market per premarket notification
submissions K120822, K132219 and K142890. |
| Technological
Characteristics: | The subject Straumann Variobase Abutments for Bridge/Bar
devices have the same Indications For Use, Implant-to-
Abutment platforms, materials, packaging and dynamic fatigue
performance as the identified Straumann Variobase Abutment
predicate devices. |
| | The subject devices differ in that they do not include the
engaging features of the implant-to-abutment interface design
allowing full axial rotation and the coronal aspect takes a form
better suited to multi-unit restorations. |
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| FEATURE | Straumann® Variobase®
Abutments for Bridges/Bars
Subject Submission | Primary Predicate
Straumann® Variobase®
Abutments
(K142890) | Reference Devices
Straumann® Multibase
(K080239) and synOcta
(K990342) Abutments | Equivalence
Discussion |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Straumann® Variobase®
prosthetic components directly
connected to the endosseous
dental implants are indicated for
use as an aid in prosthetic
rehabilitations. The prosthetic
restoration (bridge or over-
denture) can be cemented on the
Straumann® 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. They
may not be placed into
occlusion. Final abutments and
restorations may be placed into
occlusion when the implant is
fully osseointegrated. | 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. | Not applicable | Equivalent
The basic indication of
providing support for prostheses
is identical. Where the predicate
is indicated for both single-unit
and multi-unit restorations, the
subject devices are only suitable
for multi-unit restorations. This
limited indication is within the
scope of the indication of the
predicate devices. |
| Abutment
Material | Titanium-Aluminum-Niobium
alloy (Ti-6Al-7Nb) | Titanium-Aluminum-Niobium
alloy (Ti-6Al-7Nb) | Not applicable | Identical |
| Abutment
Diameter | 4.2 - 7.0 mm | 3.8 - 7.0 mm | Not applicable | Equivalent
Subject device diameters are
within the range of diameters for
the predicate device. |
| FEATURE | Straumann® Variobase®
Abutments for Bridges/Bars
Subject Submission | Primary Predicate
Straumann® Variobase®
Abutments
(K142890) | Reference Devices
Straumann® Multibase
(K080239) and synOcta
(K990342) Abutments | Equivalence
Discussion |
| Abutment
Height | 3.5 – 5.2 mm | 3.5 – 4.5 mm | Not applicable | Equivalent
The subject devices have the
same minimum height as the
Variobase predicates.
Performance of the taller subject
device is addressed via bench
testing. |
| Abutment
Apical
Design | Non-engaging Morse taper | Engaging CrossFit® and Morse
taper | Not applicable | Equivalent
The Morse taper portion of both
the subject and Variobase
predicate devices are identical.
Non-engaging abutments are
necessary so as not to introduce
mechanical constraints in the
framework that would affect fit. |
| Abutment
Coronal
Design | 10° or15° conical taper | Straight wall with detents | 6° conical taper (K990342)
30° conical taper (K080239) | Equivalent
The conic taper of the subject
devices is within the range
established by the synOcta and
Multibase predicates. |
| FEATURE | Straumann® Variobase®
Abutments for Bridges/Bars
Subject Submission | Primary Predicate
Straumann® Variobase®
Abutments
(K142890) | Reference Devices
Straumann® Multibase
(K080239) and synOcta
(K990342) Abutments | Equivalence
Discussion |
| Restoration
Material | Materials cleared by the FDA
under 21 CFR 872.6660 or
exempt materials as described
under 21 CFR 872.3060 (Noble
metal alloys) and 21 CFR
872.3710 (Base metal alloys) | 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) | Not applicable | Equivalent
The range of materials cleared
for use with the predicate
devices is within the scope of
materials indicated for the
subject devices. |
| Design
Workflow | Wax-up or Open CAD
Exempt from pre-market
notification according to 21
CFR 807.85(a)(1). | Wax-up or Open CAD | Not applicable | Identical |
| Manufacturing
Workflow | Traditional casting, pressing or
Straumann Milling Center
Exempt from pre-market
notification according to 21
CFR 807.85(a)(1). | Traditional casting, pressing or
Straumann Milling Center | Not applicable | Identical |
| Mode of
Attachment | Screw-retained or cement
retained | Screw-retained or cement
retained | Not applicable | Identical |
| Reusable | No | No | Not applicable | Identical |
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7
8
| Discussion of
Substantial
Equivalence: | The basic indication of providing support for prostheses is
identical. Where the predicate is indicated for both single-unit
and multi-unit restorations, the subject devices are only
suitable for multi-unit restorations. This limited indication is
within the scope of the indication of the predicate devices.
Subject device diameters are within the range of diameters for
the predicate devices. The subject devices have the same
minimum height as the Variobase predicates. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance of the taller subject device is addressed via bench
testing. The Morse taper portion of both the subject and
Variobase predicate devices are identical. Non-engaging
abutments are necessary so as not to introduce mechanical
constraints in the framework that would affect fit. The conic
taper of the subject devices is within the range established by
the synOcta and Multibase predicates. The bonding surface
areas for the subject devices are consistent with those of the
predicate. The range of materials cleared for use with the
predicate devices is within the scope of materials indicated for
the subject devices. |
| Performance Data: | Per 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, the substantial equivalence of the subject device(s) are
satisfactorily addressed via bench studies. Dynamic fatigue test
data consistent with FDA guidance and ISO 14801 have been
referenced in support of this submission. |
| 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. |