(501 days)
K181520 Sirona Dental CAD/CAM System (Sirona Dental), K171773 Straumann n!ce Glas Ceramic A14 Blocks (Institut Straumann AG), K173961 – Straumann BLX Implant System (Institut Straumann AG), K142890 Straumann Variobase (Institut Straumann AG), K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut Straumann AG)
No
The summary describes a physical dental abutment and its compatibility with existing CAD/CAM systems, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device, Straumann® Variobase® C, is an abutment for dental implants designed to provide support for prosthetic restorations, not to provide therapy itself.
No
The device is an abutment for dental implants, providing support for prosthetic restorations. It is a structural component and does not diagnose any condition or disease.
No
The device description clearly states the device is a physical abutment made of titanium alloy, which is a hardware component. While it is used in conjunction with software for design and milling, the device itself is not software-only.
Based on the provided information, the Straumann® Variobase® C is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Straumann® Variobase® C is a dental abutment, a physical component placed onto a dental implant to support a prosthetic restoration. It does not interact with or analyze biological specimens for diagnostic purposes.
- The intended use clearly describes a mechanical function: providing support for customized prosthetic restorations on dental implants.
- The device description focuses on materials, interfaces, and compatibility with CAD/CAM systems for manufacturing prosthetic components. This is consistent with a medical device used in a surgical and restorative procedure, not an IVD.
- The performance studies described are related to mechanical strength, fatigue, biocompatibility, and sterilization. These are typical tests for implantable or surgically placed medical devices, not IVDs.
Therefore, the Straumann® Variobase® C is a medical device, specifically a dental abutment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann® Variobase®C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C 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® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Product codes (comma separated list FDA assigned to the subject device)
NHA, PNP
Device Description
The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:
- Straumann® Variobase® C (Ti-base)
- Prosthetic Restoration (patient specific coping or crown)
- Basal Screw
The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibles and maxillae, oral cavity.
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)
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". The fatigue testing protocols developed using ISO 14801:2016 demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices.
The subject device materials are identical in formulation and manufacturing process to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
The sterilization process for the Straumann Variobase C 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"and ISO 17665-1 and ISO 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.
K151324 Variobase for CEREC (Institut Straumann AG)
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.
K181520 Sirona Dental CAD/CAM System (Sirona Dental), K171773 Straumann n!ce Glas Ceramic A14 Blocks (Institut Straumann AG), K173961 – Straumann BLX Implant System (Institut Straumann AG), K142890 Straumann Variobase (Institut Straumann AG), K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut Straumann AG)
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Institut Straumann AG % Jennifer Jackson Directory, Regulatory Affairs Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K192742
Trade/Device Name: Straumann® Variobase® C Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: January 14, 2021 Received: January 15, 2021
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name:
Straumann® Variobase® C
Indications for Use (Describe)
The Straumann® Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations Variobase® C 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® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Straumann® Variobase® C
510(k) Summary
1 510(k) Summary
Submitter's Contact Information 1.1
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | On behalf of: |
| | Institut Straumann AG
Peter Merian Weg, 12
CH-4002 Basel, Switzerland |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By &
Alternate Contact: | Gordon Dodds
Manager Design Control QM
Etkon GmbH
Phone number: +49 89 30 90 75 291 |
| Date of Submission: | February 12, 2021 |
1.2 Name of the Device
| Trade Names: | Straumann® Variobase® C |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA, PNP |
| Classification Panel: | Dental |
4
Straumann® Variobase® C
510(k) Summary
Predicate Device(s) 1.3
Primary Predicate:
-
K151324 Variobase for CEREC (Institut Straumann AG) .
Reference Devices: -
K181520 Sirona Dental CAD/CAM System (Sirona Dental) .
-
K171773 Straumann n!ce Glas Ceramic A14 Blocks (Institut Straumann AG) .
-
. K173961 – Straumann BLX Implant System (Institut Straumann AG)
-
K142890 Straumann Variobase (Institut Straumann AG) .
-
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut . Straumann AG)
1.4 Device Description
The Straumann® Variobase® C abutments are two-piece abutments composed of the following components:
- . Straumann® Variobase® C (Ti-base)
- . Prosthetic Restoration (patient specific coping or crown)
- . Basal Screw
The Straumann® Variobase® C abutments provide the interface for copings or crowns designed and milled using a Sirona Dental CAD/CAM System with the Straumann dental implant platforms: RC (Regular CrossFit®), NC (Narrow CrossFit®), NNC (Narrow Neck CrossFit®), RB/WB(Regular Base/Wide Base), and WB (Wide Base). The Straumann® Variobase® C abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases," made from a titanium-aluminum-niobium (TAN) alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona MC XL prosthetic milling systems, and the base portion is available to fit the Straumann® dental implant platforms listed above. The top half materials that are compatible with the Straumann Variobase C abutments include IPS e.max CAD, inCoris ZI, and n!ce. The top half material compatibility is dependent on the dental implant platform, with inCoris Zl and n!ce only being compatible with the RC (Regular CrossFit®) and NC (Narrow CrossFit®) platforms.
5
Straumann® Variobase® C
510(k) Summary
1.5 Intended Use
Straumann® Variobase C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns.
1.6 Indications for Use
The Straumann® Variobase®C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® C 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® C abutments are to be designed using Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
1.7 Comparison of Technological Characteristics and Indications for Use
The subject and primary predicate Indications for Use differ only in the removal of the software version and the change in trade name. The software version validated as part of this submission is captured in Table 1 below, and the removal of this information from the Indications for Use statement does not change the intended use of the subject device system.
As outlined in Table 1, the subject system includes a combination of previously-cleared technologies that are now being implemented into one system. The Variobase technology has received prior clearance for each implant body compatibility. The ceramic materials have received prior clearance for use as the second piece of a two-piece abutment under product code NHA and for use with the Sirona CAD/CAM digital workflow. Performance testing has addressed any differences resultant from these new combinations of technologies.
The technological characteristics of the subject devices are compared to the primary predicate device in Table 1. The reference device K190662 is included for reference to MRI compatibility.
6
Straumann® Variobase® C
510(k) Summary
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 |
| Indications for
Use | The Straumann®
Variobase® Care
titanium alloy abutments
placed onto Straumann
dental implants to
provide support for
customized prosthetic
restorations. Straumann®
Variobase® Cabutments
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®
C abutments are to be
designed using Sirona
CEREC Software and
manufactured using a
Sirona CEREC or inLab
MC X or MC XL milling
unit. | The Straumann®
Variobase® for CEREC®
are titanium alloy
abutments placed onto
Straumann dental
implants to provide
support for customized
prosthetic restorations.
Straumann® Variobase®
for CEREC® 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®
for CEREC® abutments
are to be designed using
Sirona inLab software
(Version 3.65 or higher)
or Sirona CEREC
Software (Version 4.2 or
higher) and
manufactured using a
Sirona CEREC or inLab
MC X or MC XL milling
unit. | The Sirona Dental CAD/CAM
System is intended for use in
partially or fully edentulous
mandibles and maxillae in
support of single or multiple-
unit cement retained
restorations. For the BH 3.0
S, SSO 3.5 L and SBL 3.3 L
titanium bases, the indication
is restricted to the
replacement of single lateral
incisors in the maxilla and
lateral and central incisors in
the mandible. The system
consists of three major parts:
TiBase, inCoris
mesostructure, and CAD/CAM
software. Specifically, the
inCoris mesostructure and
TiBase components make up
a two-piece abutment which is
used in conjunction with
endosseous dental implants
to restore the function and
aesthetics in the oral cavity.
The inCoris mesostructure
may also be used in
conjunction with the Camlog
Titanium base CAD/CAM
(types K2244.XXXX)
(K083496) in the Camlog
Implant System. The
CAD/CAM software is
intended to design and
fabricate the inCoris
mesostructured. The inCoris
mesostructure and TiBase
two-piece abutment is
compatible with the following
implant systems: | 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® nice
Glass Ceramic A14
Blocks are intended
to be ceramic
mesostructures
cemented to the Ti-
base for a two-piece
hybrid abutment for
single tooth
restorations or
hybrid abutment
crowns, used in
conjunction with
endosseous dental
implant to restore
chewing function.
The following
compatibilities
apply:
Straumann RC
Variobase for
CEREC - 022.0024 -
Block Size L
Straumann NC
Variobase for
CEREC - 022.0025 -
Block Size L
Straumann RN
Variobase for
CEREC - 022.0019 -
Block Size L
Straumann WN
Variobase for
CEREC - 022.0020 -
Block Size L | Straumann® BLX Implants
Straumann® BLX Implants are suitable for endosteal
implantation in the upper and lower jaw and for the
functional and esthetic oral rehabilitation of edentulous
and partially edentulous patients. BLX Implants can
be placed with immediate function on single-tooth
applications when good primary stability is achieved
and with appropriate occlusal loading to restore
chewing function. The prosthetic restorations are
connected to the implants through the corresponding
abutment components.
Straumann® BLX Closure Caps and Healing
Abutments
Straumann® Closure Caps and Healing Abutments are
indicated to be placed in the patient's mouth at the end
of the implant placement to protect the inner
configuration of the implant and to shape, maintain
and stabilize the soft tissue during the healing process.
Closure caps and healing abutments should be used
only with suitable implant connections. Straumann
Closure Caps and Healing Abutments have a
maximum duration of usage of 6 months.
Straumann® BLX Basal Screws and Temporary
Abutments
Prosthetic components directly or indirectly connected
to the endosseous dental implant are intended for use
as an aid in prosthetic rehabilitations. Temporary
components can be used prior to the insertion of the
final components to maintain, stabilize and shape the
soft tissue during the healing phase; they may not be
placed into occlusion. Final abutments may be placed
into occlusion when the implant is fully
osseointegrated. BLX Temporary Abutments have a
maximum duration of usage of 180 days.
Straumann® BLX Variobases
The 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
(crowns) can be cemented onto the Straumann®
Variobase® prosthetic components. A temporary
restoration can be used prior to the insertion of the
final components to maintain, stabilize and shape the
soft tissue during the healing phase; they must be
placed out of occlusion. 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. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
| K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 |
| Compatible
Implants | Straumann Bone Level
implantshaving the NC
and RC implant-to-
abutment interface
geometries.
Straumann Tissue Level
implantshavingthe NNC
implant-to-abutment
interface geometries.
Straumann BLX implants
having the RB/WB and
WB implant-to-abutment
interface geometries. | Straumann Bone Level
implantshaving the NC
and RC implant-to-
abutment interface
geometries.
Straumann Tissue Level
implantshaving the RN
and WN implant-to-
abutment interface
geometries. | Nobel Biocare - Replace,
Active, and Branemark
Straumann - Sy nocta and
Bone Lev el
Dentsply Sirona Implants –
Osseospeed, Xive,
Osseospeed EV, and
Anky los
Biomet 3i – Osseotite and
Certain
Zimmer – Tapered Screw-
Vent
Thommen Medical - SPI
Element, SPI Element Inicell,
SPI Contact Inicell
Osstem/Hiossen – Osstem
TS Implant System and
Hiossen Implant System
Biohorizons (Internal
Connection | Straumann Bone Level
implantshaving the NC
and RC implant-to-
abutment interface
geometries.
Straumann Tissue Level
implantshavingthe
NNC, RN, and WN
implant-to-abutment
interface geometries. | Straumann Bone
Level implants
having the NC and
RC implant-to-
abutment interface
geometries.
Straumann Tissue
Level implants
having the RN and
WN implant-to-
abutment interface
geometries. | Straumann BLX implantshaving the
RB/WB and WB implant-to-abutment
interface geometries. |
| Compatible
Restoration
Materials | Sirona inCorisZi meso
(S and L) – K181520
Ivoclar IPS e.max CAD
(S and L) – K151324
Straumann n!ce Glass
Ceramic A14 Blocks (L) –
K171773 | Sirona inCorisZi (L) –
K062509 and K123664
Ivoclar IPS e.max CAD
(S and L) – K132209
Ivoclar TelioCAD (S and
L) – K093708 | Sirona inCorisZi (S and
L) | 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) | Straumann n!ce
Glass Ceramic A14
Blocks (L) | Digital Workflow:
polycon® ae (temporary)
IPS e.max® CAD Ceramic (permanent) |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
| K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 |
| Coronal
Diameters | NC:
2.98 mm (Size S or L)
RC:
3.38 mm (Size L)
NNC:
2.98 mm (Size S)
RB/WB:
2.98 mm (Size S) and
3.38 mm (Size L)
WB:
3.38 mm (Size L) | NC: 3.38 mm (Size L)
RC: 3.38 mm (Size L)
RN: 3.38 mm (Size L)
WN: 3.38 mm (Size L) | NC: 3.38 mm (Size L)
RC: 3.38 mm (Size L) | NC: 2.80 mm
RC: 2.90 mm
NNC: 2.80 mm | N/A | RB/WB:
2.80 mm (3.8 mm diameter platform)
2.90 mm (4.5 mm diameter platform)
WB: 2.90 mm |
| Abutment
Platform
Diameters | NC:
3.8 mm
RC:
4.6 mm
NNC:
3.9 mm
RB/WB: 3.8 mm &
4.5mm
WB:
5.5 mm | NC: 4.5 mm
RC: 4.6 mm
RN: 5.0 mm
WN: 7.0 mm | 3.0-7.0 mm | 3.8 mm - 7.0 mm | NC: 4.5 mm
RC: 4.6 mm
RN: 5.0 mm
WN: 7.0 mm | RB/WB: 3.8 mm & 4.5mm
WB: 5.5 mm |
| Stock Titanium
Base Material | Titanium alloy
(Ti-6Al-7Nb or TAN) | Titanium alloy
(Ti-6Al-7Nb or TAN) | Titanium alloy | Titanium alloy
(Ti-6Al-7Nb or TAN) | Titanium alloy
(Ti-6Al-7Nb or TAN) | Titanium alloy
(Ti-6Al-7Nb or TAN) |
| Construction | Two-piece abutment
base with bonded
prosthesis produced via
the Sirona Dental
CAD/CAM System digital
workflow. | Two-piece abutment
base with bonded
prosthesis produced via
the Sirona Dental
CAD/CAM System digital
workflow. | Two-piece abutment
base with bonded
prosthesis produced via
the Sirona Dental
CAD/CAM System digital
workflow. | Two-piece abutment
base with bonded
prosthesis produced via
traditional or CARES
CAD/CAM digital
workflow. | Two-piece abutment
base with bonded
prosthesis produced
via the Sirona
Dental CAD/CAM
System digital
workflow. | Two-piece abutment base with bonded
prosthesis produced via traditional or
CARES CAD/CAM digital workflow. |
| Maximum
Angulation | 20° controlledin design
software | 20° controlledin design
software | 20° controlledin design
software | 30° | 20° controlled in
design software | 30° |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
| K Number | K192742 | K151324 | K181520 | K142890 | K171773 | K173961 |
| Software | Sirona CEREC Software
Version 4.6.1 | Sirona inLab software
Version 3.65 or higher
Sirona CEREC Software
Version 4.2 or higher | CEREC SW version
4.6.1 | N/A | Sirona inLab
software Version
3.65
Sirona CEREC
Software Version
4.2 | N/A |
| Sterility | Provided non-sterile -
terminally sterilized via
autoclave prior to
implantation. | Provided non-sterile -
terminally sterilized via
autoclave prior to
implantation. | Provided non-sterile -
terminally sterilized via
autoclave prior to
implantation. | Provided non-sterile -
terminally sterilized via
autoclave prior to
implantation. | Provided non-sterile
- terminally
sterilized via
autoclave prior to
implantation. | Provided non-sterile - terminally
sterilized via autoclave prior to
implantation. |
7
Straumann® Variobase® C
510(k) Summary
8
Straumann® Variobase® C
510(k) Summary
9
Straumann® Variobase® C
510(k) Summary
Table 1 – Comparison of subject device versus primary predicate device – two-piece abutment
10
Straumann® Variobase® C
510(k) Summary
Performance Testing 1.8
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". The fatigue testing protocols developed using ISO 14801:2016 demonstrated that the Straumann Variobase C abutments are equivalent to the predicate and reference devices.
The subject device materials are identical in formulation and manufacturing process to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
The sterilization process for the Straumann Variobase C 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"and ISO 17665-1 and ISO 17665-2.
Conclusion 1.9
The documentation submitted in this premarket notification demonstrates the Straumann Variobase C are substantially equivalent to the primary predicate devices.