(200 days)
No
The summary describes a physical prosthetic component and its manufacturing process, with no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a prosthetic component used in dental rehabilitations, not a device intended to treat or cure a disease or condition.
No
Explanation: The device is a prosthetic component (abutment) used to support dental restorations on implants, not to diagnose medical conditions.
No
The device description explicitly states the device is a non-engaging abutment made from Ti-6Al-7Nb (TAN) and includes a basal screw, indicating it is a physical hardware component. While software is mentioned for design and validation, the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a prosthetic component used in dental implant rehabilitations. It's a physical component that supports a bridge or bar, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device is described as a non-engaging abutment made from Ti-6Al-7Nb (TAN). This is a physical implant component, not a diagnostic tool.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's health status.
- User and Setting: The intended user is a dental laboratory technician, and the setting is related to dental prosthetics. This aligns with a medical device used in treatment, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples from the human body to diagnose diseases or conditions. This device is a prosthetic component used in the treatment of tooth loss.
N/A
Intended Use / Indications for Use
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components 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
The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) 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)
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.
The following testing has been conducted or substantial equivalence to tested predicate devices has been demonstrated:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801.
- Software validation conforming to the requirements of IEC 62304.
- Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2 (K151157 Straumann Variobase for Bridge/Bar).
- Biocompatibility testing conforming to ISO-10993-1 (K120822 Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC)
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.
K151157 Straumann Variobase for Bridge/Bar, K142890 Straumann Variobase Abutments, K120822 Straumann CARES Variobase Abutment, K132844 Straumann CARES Bone Level Screw Retained Bars, K041295 RN Synocta UCLA Gold Abutment for . the Straumann Dental Implant
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.
K120822, K142890, K132844, K041295
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 17, 2018
Institut Straumann AG Jennifer Jackson Director, Regulatory Affairs and Quality 60 Minuteman Road Andover, Massachusetts 01810
Re: K173968
Trade/Device Name: Straumann® Variobase™ for Bridge/Bar Cylindrical Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2018 Received: June 18, 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. 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); 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.
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
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
Straumann® Variobase™ for Bridge/Bar Cylindrical
Indications for Use (Describe)
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patientspecific prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated.
All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components 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) Subpart C)
| | Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)Equivalent
3
510(k) Summary
| Submitter's Contact Information | |
|---|---|
| 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: | Jennifer Jackson |
| Director, Regulatory Affairs & Quality | |
| Prepared By: | Dr. Gordon Dodds |
| Manager Design Control QM | |
| Etkon GmbH | |
| Date Prepared: | July 16, 2018 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Name of the Device | |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name: | Straumann® Variobase™ for Bridge/Bar Cylindrical |
| Predicate Device(s): | |
| Predicate Device(s): | K151157 Straumann Variobase for Bridge/Bar K142890 Straumann Variobase Abutments K120822 Straumann CARES Variobase Abutment |
| NNC, RN, WN, NC, RC K132844 Straumann CARES Bone Level Screw | |
| Retained Bars, Straumann CARES Bone Level | |
| Screw Retained Bridges |
4
- K041295 RN Synocta UCLA Gold Abutment for . the Straumann Dental Implant
Device Description
The Straumann® Variobase™ for Bridge/Bar Cylindrical, see Figure 1 and Table 1, are non-engaging (without rotational lock) 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.
Image /page/4/Picture/4 description: The image shows five dental implant abutments labeled NC, RC, NNC, RN, and WN. The abutments are all silver in color, except for the NC abutment, which has a gold-colored base. The abutments are all different shapes and sizes, with the NC abutment being the smallest and the WN abutment being the largest. The abutments are used to connect dental implants to crowns or other dental prosthetics.
Figure 1 Straumann Variobase for Bridge/Bar Cylindrical
Table 1 - Listing of devices
| Device Name | Device Number |
|---|---|
| Straumann® NC Variobase™ for Bridge/Bar | |
| Cylindrical | 022.0110 / 010.6085 |
| Straumann® RC Variobase™ for Bridge/Bar | |
| Cylindrical | 022.0111 / 010.6086 |
| Straumann® RN Variobase™ for Bridge/Bar | |
| Cylindrical | 048.378 / 010.6083 |
| Straumann® WN Variobase™ for Bridge/Bar | |
| Cylindrical | 048.379 / 010.6084 |
| Straumann® NNC Variobase™ for Bridge/Bar | |
| Cylindrical | 048.377 / 010.6082 |
Intended Use:
5
Straumann® Variobase™ for Bridge/Bar Cylindrical are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures
Indications For Use
Straumann® Variobase™ for Bridge/Bar Cylindrical prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The patient-specific prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase™ for Bridge/Bar Cylindrical 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. Temporary restorations are indicated to be placed out of occlusion. Straumann® Variobase™ for Bridge/Bar Cylindrical and patient-specific restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed Straumann® Variobase® for Bridge/Bar Cylindrical prosthetic components are intended to be sent to Straumann for manufacture at a validated milling center.
6
Technological Chracteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table.
Table 2: Substantial Equivalence Comparison
7
| FEATURE | Subject Device
Straumann® Variobase™ for Bridge/Bar
Cylindrical
Subject Submission | Predicate Device
Straumann® Variobase™
Abutments for Bridge/Bar
(K151157) | Reference Predicate
Devices
Straumann® Variobase™
Abutments
(K120822, K142890)
Straumann® Screws
(K132844, K041295) | Equivalence
Discussion |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Straumann® Variobase™ for Bridge/Bar
Cylindrical prosthetic components directly
connected to the endosseous dental implants
are indicated for use as an aid in prosthetic
rehabilitations. The patient-specific prosthetic
restoration (bridge or over-denture) can be
cemented on the Straumann® Variobase™ for
Bridge/Bar Cylindrical 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. Temporary
restorations are indicated to be placed out of
occlusion. Straumann® Variobase™ for
Bridge/Bar Cylindrical and patient-specific
restorations may be placed into occlusion
when the implant is fully osseointegrated.
All digitally designed Straumann®
Variobase® for Bridge/Bar Cylindrical
prosthetic components are intended to be
sent to Straumann for manufacture at a
validated milling center. | Straumann® Variobase® prosthetic
components directly or indirectly
connected to the endosseous dental
implant are intended 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. | Not applicable | Identical
Section regarding
production methods has
been added. The same
production methods are
used for the predicate
device. |
| Abutment
Material | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy (Ti-
6Al-7Nb) | Not applicable | Identical |
| FEATURE | Subject Device
Straumann® Variobase™ for Bridge/Bar
Cylindrical
Subject Submission | Predicate Device
Straumann® Variobase™
Abutments for Bridge/Bar
(K151157) | Reference Predicate
Devices
Straumann® Variobase™
Abutments
(K120822, K142890)
Straumann® Screws
(K132844, K041295) | Equivalence
Discussion |
| Abutment
Diameter | 4.5 – 7.0 mm | 4.2 – 7.0 mm | Not applicable | Equivalent
The subject device NC
interface is 0.3 mm wider
and gives more support |
| Abutment
Height | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Not applicable | Identical |
| Abutment
Apical
Design | Non-engaging (no rotational lock) Morse taper | Non-engaging (no rotational lock)
Morse taper | Not applicable | Identical |
| Abutment
Coronal
Design | Straight wall with detents | 10° or15° conical taper | K120822, K142890 -
Straight wall with detents | Equivalent
The coronal design is
identical to the reference
predicate devices and has
the equivalent function as
the predicate devices. |
| Basal Screw
Design | NC/RC Conical Head Screw Bone Level
RN/WN Conical Head Screw Tissue Level | | K132844, K041295 -
NC/RC Conical Head Screw
Bone Level
RN/WN Conical Head
Screw Tissue Level | Identical |
| FEATURE | Subject Device
Straumann® Variobase™ for Bridge/Bar
Cylindrical
Subject Submission | Predicate Device
Straumann® Variobase™
Abutments for Bridge/Bar
(K151157) | Reference Predicate
Devices
Straumann® Variobase™
Abutments
(K120822, K142890)
Straumann® Screws
(K132844, K041295) | Equivalence
Discussion |
| Restoration
Types
Supported | Patient-specific prosthetic bridge or over-
denture | Patient-specific prosthetic bridge or
over-denture | Not applicable | Identical |
| 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) | 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) | Not applicable | Identical |
| Design
Workflow | Wax-up or CAD | Wax-up or CAD | Not applicable | Identical |
| Manufacturing
Workflow | Traditional casting or Straumann Milling Center | Traditional casting, pressing or
Straumann Milling Center | Not applicable | Identical |
| Mechanical
Stability | Dynamic fatigue test
Pass | Dynamic fatigue test
Pass | Not applicable | Identical |
| Sterilization | Steam autoclave | Steam autoclave | Not applicable | Identical |
| FEATURE | Subject Device
Straumann® Variobase™ for Bridge/Bar
Cylindrical
Subject Submission | Predicate Device
Straumann® Variobase™
Abutments for Bridge/Bar
(K151157) | Reference Predicate
Devices
Straumann® Variobase™
Abutments
(K120822, K142890)
Straumann® Screws
(K132844, K041295) | Equivalence
Discussion |
| Mode of Action | Screw-retained or cement retained | Screw-retained or cement retained | Not applicable | Identical |
| Reusable | No | No | Not applicable | Identical |
8
9
10
11
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.
The following testing has been conducted or substantial equivalence to tested predicate devices has been demonstrated:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- . Software validation conforming to the requirements of IEC 62304.
- . Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2 (K151157 Straumann Variobase for Bridge/Bar).
- Biocompatibility testing conforming to ISO-10993-1 (K120822 Straumann CARES . Variobase Abutment NNC, RN, WN, NC, RC)
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.