(151 days)
No
The description focuses on the mechanical design and manufacturing process of a dental abutment, with no mention of AI or ML for analysis, design, or manufacturing. The digital workflow mentioned uses standard CAD software, not AI/ML.
No
The device provides support for prosthetic restorations on dental implants and aids in forming soft tissue; it does not directly treat a disease or condition.
No
The device is a titanium base providing support for customized prosthetic restorations on dental implants, not for diagnosing medical conditions.
No
The device description clearly states it is a physical titanium base and associated components, not software. While it mentions a digital workflow using dental CAD software, 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 titanium base placed onto dental implants to support prosthetic restorations. This is a mechanical/structural function within the body.
- Device Description: The description details a physical component (a titanium base) used in dental procedures.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a component of a dental restoration.
N/A
Intended Use / Indications for Use
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. 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. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS 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 Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).
There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.
The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.
There are three components to the Straumann® Variobase® for Crown AS:
- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw
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: Rootform 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:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- Software validation conforming to the requirements of IEC 62304. ●
- o Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
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 and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. 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" in blue, and the word "ADMINISTRATION" in a smaller font below.
March 30, 2018
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K173379
Trade/Device Name: Straumann® Variobase® for Crown AS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 2, 2018 Received: March 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
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) K173379
Device Name
Straumann® Variobase® for Crown AS
Indications for Use (Describe)
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. 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. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) 801 Subpart C)
□ Over-The-Counter Use (21 CFR
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."
FORM FDA 3881 (8/14) Equivalent
Page 1 of 1
3
K173379 510(k) Summary
Submitter's Contact Information 1.1
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810 | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Jennifer M. Jackson, MS
Director, Regulatory Affairs and Quality
Tel +1 (978) 747 2509
Fax +1 (978) 747 0023 | | |
| Prepared By: | Dr. Gordon Dodds
Manager Design Control QM
Etkon GmbH | | |
| Date Prepared: | March 26, 2018 | | |
| Product Code(s): | NHA (§872.3630) | | |
| Device Class: | II (§872.3630) | | |
| Classification Panel: | Dental | | |
| 1.2 Name of the Device | | | |
| Classification Name: | Endosseous dental implant abutment (§872.3630) | | |
| Proprietary Name: | Straumann® Variobase® for Crown AS | | |
| 1.3 Predicate Device(s) | | | |
| Predicate Device(s): | • K142890 – Straumann Variobase Abutments | | |
| Reference Device(s): | • K120822 – Straumann CARES Variobase Abutments
• K170354 – Straumann Variobase Abutments
• K170356 - Straumann Variobase Abutments | | |
4
1.4 Device Description
The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).
There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.
The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.
There are three components to the Straumann® Variobase® for Crown AS:
- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw
Image /page/4/Picture/9 description: The image shows a dental implant with several labeled components. The "Basal screw" is at the top, followed by the "Prosthetic restoration (full contour crown)". Below that is the "Straumann® Variobase AS Ti-base", which connects to the implant itself. The implant is a cylindrical, screw-like structure designed to be embedded in the jawbone.
Figure 1 – Two-piece abutment consisting of a Straumann® Variobase® for Crown AS and a milled coping
5
The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:
- Cast materials: ●
- Type 4 metals (ISO 22674) O
- o Base metal alloys (e.g., cobalt-chromium (CoCr))
- o Noble metal alloys (e.g., gold alloy)
- Press materials:
- o IPS e.max® Press Ceramic
- Digital materials: ●
- coron® O
- zerion® LT O
- polycon® ae O
- zerion ML O
- zerion UTML O
- IPS e.max® CAD Ceramic O
- O n!ce
1.5 Intended Use
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
1.6 Indications for Use
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. 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. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
6
1.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table.
| Feature | SUBJECT
Straumann® Variobase® for
Crown AS | PREDICATE
K142890, Straumann
Variobase Abutments | REFERENCE
K120822 Straumann CARES
Variobase Abutment | Equivalence
Discussion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Straumann® Variobase® for
Crown AS is a titanium base
placed onto Straumann dental
implants to provide support for
customized prosthetic
restorations. Straumann®
Variobase® for Crown AS are
indicated for screw retained
single tooth or cement-retained
single tooth and bridge
restorations. 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. All digitally designed
copings and/or crowns for use
with the Straumann® Variobase®
for Crown AS 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. | 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
Temporary materials
crowns (Polycon AE) are
used with the subject
and predicate devices.
The subject devices
include advice to ensure
that temporary
restorations are placed
out of occlusion in order
to assist with implant
stabilization.
Updates to the predicate
device IFUs, made since
510(k) clearance, give
identical advice as the
subject device. |
| TiBase
Material | Titanium-Aluminum-Niobium
alloy
(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium
alloy
(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium
alloy
(Ti-6Al-7Nb) | Identical |
| Table 1 - Device Substantial Equivalence Comparison - Straumann® Variobase® for Crown AS |
|---|
| ------------------------------------------------------------------------------------------ |
7
| Feature | SUBJECT
Straumann® Variobase® for
Crown AS | PREDICATE
K142890, Straumann
Variobase Abutments | REFERENCE
K120822 Straumann CARES
Variobase Abutment | Equivalence
Discussion |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment
Diameter | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | Identical |
| Prosthetic Height
(Abutment Post
Height) | 3.5 mm – 6.5 mm | 3.5 mm - 4.5 mm | 3.5 mm – 4.5 mm | Equivalent
The option for additional
height of the apical part
of the TiBase in
Straumann® Variobase®
for Crown AS provides
for a larger area of
retentive cement and
material for resisting
force. |
| Mode of
Attachment | Screw-retained or cement
retained | Screw-retained or cement
retained | Screw-retained or cement
retained | Identical |
| Basal Screws | TAN Basal screws for NC/RC,
NNC. RN/WN interfaces with a
wider screwhead (~10% wider) ,
to allow for up to 25° of
angulation with respect to the
Variobase AS axis with an
angled screwdriver. Screws are
marked with a green ring so they
can be identified. | TAN Basal screws for NC/RC,
NNC, RN/WN interfaces, with
limited angled entry of
screwdriver. | TAN Basal screws for NC/RC,
NNC, RN/WN interfaces, with
limited angled entry of
screwdriver. | Equivalent
A wider screw head
permits the angulation.
The cone below the
screwhead is slightly
longer to make the
screw head wider. The
screws have the same
overall length, |
| Reusable | No | No | No | Identical |
| Source of Input
Files for Crown
Design | Intra-Oral Scanners
Bench-top Scanners | Intra-Oral Scanners
Bench-top scanners | Intra-Oral Scanners
Bench-top scanners | Identical |
| Design
Environment | Straumann CARES Visual:
Closed CAD System facilitating
the design of tooth-borne
restorations and restorations
used in conjunction with the
devices of the Straumann Dental
Implant System (SDIS). | Straumann CARES Visual:
Closed CAD System facilitating
the design of tooth-borne
restorations and restorations
used in conjunction with the
devices of the Straumann Dental
Implant System (SDIS). | Straumann CARES Visual:
Closed CAD System facilitating
the design of tooth-borne
restorations and restorations
used in conjunction with the
devices of the Straumann Dental
Implant System (SDIS). | Identical |
| Feature | SUBJECT
Straumann® Variobase® for
Crown AS | PREDICATE
K142890, Straumann
Variobase Abutments | REFERENCE
K120822 Straumann CARES
Variobase Abutment | Equivalence
Discussion |
| Restoration
Types Supported | Patient-specific copings and
crowns for Variobase for Crown
AS | Patient-specific copings and
crowns for Variobase for Crown | Patient-specific copings and
crowns for Variobase for Crown | Equivalent |
| Supported
Restorative
Materials | Traditional Workflow:
Type 4 Metals (ISO 22674)
IPS e.max® Press Ceramic
Digital Workflow:
IPS e.max® CAD Ceramic
(permanent)
coron® (permanent)
zerion® (permanent)
polycon® ae (temporary)
zerion ML
zerion UTML
n!ce | Traditional Workflow:
Type 4 Metals (ISO 22674)
IPS e.max® Press Ceramic
Digital Workflow:
IPS e.max® CAD Ceramic
(permanent)
coron® (permanent) | Digital Workflow:
polycon® ae (temporary)
zerion® (permanent) | Identical |
| Fabrication
Workflow | Traditional casting or pressing
or
Straumann Milling | Traditional casting or pressing
or
Straumann Milling | Straumann Milling | Identical |
| Reusable | No | No | No | Identical |
8
9
1.8 Performance Testing
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform 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:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- Software validation conforming to the requirements of IEC 62304. ●
- o Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
| Variobase
materials | Fatigue tests -
predicates | Sterilization
validation
predicates | Biocompatibility
testing -
predicates |
|---------------------------|-------------------------------|-------------------------------------------|---------------------------------------------|
| coron® | K142890 | K142890 | K142890 |
| zerion® LT | Subject device | Subject device | K120822 |
| polycon® ae | K142890 | K120822 | K142890 |
| zerion ML/ zerion
UTML | K170356 | K170356 | K170356 |
| n!ce | K170354 | K170354 | K170354 |
| IPS e.max CAD | K142890 | K142890 | K142890 |
●
1.9 Conclusion
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.