(83 days)
No
The summary describes a physical dental abutment and its compatibility with existing CAD/CAM systems. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a dental abutment designed to support prosthetic restorations. Its function is mechanical and structural, providing an interface for crowns or copings on dental implants, rather than directly treating a disease or condition.
No
Explanation: This device is described as an abutment, which is a component placed onto dental implants to support prosthetic restorations. Its function is structural, providing an interface for crowns or copings, rather than diagnosing a condition or disease.
No
The device description clearly outlines physical components made of titanium alloy (abutments, basal screw) and mentions manufacturing processes like milling. While software is used for design, the core device is a physical implant component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Straumann® TLX Variobase® C is a dental abutment, a component used in dental implant procedures to support prosthetic restorations (crowns or bridges). Its purpose is mechanical support within the mouth, not the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any components, processes, or intended uses related to analyzing biological samples or providing diagnostic information.
Therefore, the Straumann® TLX Variobase® C is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® TLX 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® TLX Variobase® C abutments are two-piece abutments composed of the following components:
- . Straumann® TLX Variobase® C (Ti-base)
- Prosthetic Restoration (patient specific coping or crown) .
- . Basal Screw
The Straumann® TLX 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 platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX 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 material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD. The design parameters are provided in Table 1.
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)
Dynamic fatique and static strength tests were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated that the Straumann®TLX Variobase® C abutments are equivalent to the predicate and reference devices.
The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
The sterilization process for the Straumann® TLX 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".
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the Sirona Dental CAD/CAM System. Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
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.
K181520, K151324, K200586, K142890, K190662
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K220878
Trade/Device Name: Straumann® TLX Variobase® C Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: March 24, 2022 Received: March 25, 2022
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 I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220878
Device Name
Straumann® TLX Variobase® C
Indications for Use (Describe)
The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX Variobase® C abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations.
All digitally designed copings and/or crowns for use with the Straumann® TLX 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) 図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (6/20)
3
Straumann® TLX Variobase® C
510(k) Summary
Submitter's Contact Information
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052
On the behalf of:
Institut Straumann AG
Peter MerianWeg 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
Institut Straumann AG
Phone number: +49 89 30 90 75 291 |
| Date of Submission: | June 16, 2022 |
Name of the Device
| Trade Names: | Straumann® TLX Variobase® C |
|---|---|
| Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Regulation Number: | §872.3630 |
| Device Classification: | II |
| Primary Product Code: | NHA |
| Secondary Product Code: | PNP |
| Classification Panel: | Dental |
4
Straumann® TLX Variobase® C
510(k) Summary
Predicate Device(s)
Primary Predicate:
-
K192742 Straumann Variobase C .
Reference Devices: -
K181520 Sirona Dental CAD/CAM System (Sirona Dental) .
-
K151324 Variobase for CEREC (Institut Straumann AG) ●
-
. K200586 - Straumann TLX Implant System (Institut Straumann AG)
-
K142890- Straumann Variobase (Institut Straumann AG) .
-
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems (Institut . Straumann AG)
Device Description
The Straumann® TLX Variobase® C abutments are two-piece abutments composed of the following components:
- . Straumann® TLX Variobase® C (Ti-base)
- Prosthetic Restoration (patient specific coping or crown) .
- . Basal Screw
The Straumann® TLX 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 platform: NT (Narrow TorcFit), RT (Regular TorcFit), and WT (Wide TorcFit). The Straumann® TLX 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 material that is compatible with the Straumann® TLX Variobase® C abutments is IPS e.max CAD. The design parameters are provided in Table 1.
5
Straumann® TLX Variobase® C
510(k) Summary
| Abutment | lvoclar IPS e.max CAD |
|---|---|
| Material minimum wall-thickness | 0.8 mm |
| Maximum angle of restoration | 20° |
| Minimum post height of crown | 5.2 mm |
| Material duration of use | Permanent |
Table 1 – Design parameters
PANAVIA F2.0 dental cement (K032455) is to be used for cementing the prosthetic restoration to the Straumann® TLX Variobase® C to complete the finished, two-piece CAD/CAM dental abutment.
Intended Use
Straumann® TLX Variobase® C abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns.
Indications for Use
The Straumann® TLX Variobase® C are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® TLX 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® TLX 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.
Technological Characteristics
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 C technology has received prior clearance for each Straumann implant body compatibility. The IPS e.max CAD material has 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 new combinations of technologies.
The technological characteristics of the subject devices are compared to the primary predicate device in Table 2. The reference device K190662 is included for reference to MRI compatibility.
6
Straumann® TLX 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 | K200586 |
| Indications for
Use | The Straumann® TLX
Variobase® C are
titanium alloy abutments
placed onto Straumann
dental implants to
provide support for
customized prosthetic
restorations. Straumann®
TLX 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® TLX
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® 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. | 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. | TLX Dental Implant:
Straumann TLX Implants are suitable for endosteal
implantation in the upper and lower jaws and for the
functional and esthetic oral rehabilitation of edentulous
and partially edentulous patients. TLX Implants can be
placed with immediate function on single-tooth and
multi-unit restorations 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.
TLX Closure Caps and Healing Caps:
Straumann Closure Caps and Healing Caps 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 form, maintain and
stabilize the soft tissue during the healing process.
Closure caps and healing caps should be used only
with suitable implant connections. They have a
maximum duration of usage of 6 months.
TLX Temporary Abutment:
TLX Temporary Abutments 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. TLX Temporary
Abutments have a maximum duration of usage of 180
days.
TLX Variobase for Crown:
Straumann Variobase prosthetic components directly
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.
TLX CARES Abutment TAN:
The Straumann CARES Abutments TAN are indicated
for single tooth replacement and multiple tooth
restorations. The prosthetic restoration can be
cemented.
TLX Screw-retained Bridges and Bars:
CARES Screw-retained Bridges and Bars (SRBB) are
indicated for use as bars and bridges that attach to |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | | K192742 | K151324 | K181520 | K142890 | K200586 |
| | | | | | | implants to provide support for prosthetic
reconstructions such as bridges and overdentures.
The final processed products have the purpose of
restoring chewing function. Straumann CARES Screw-
retained Bridges and Bars are indicated for Screw-
retained restorations. Straumann CARES Screw-
retained Bridges and Bars are designed to interface
with the Bone Level (BL), Tissue Level (TL), BLX
implants and TLX implants of the Straumann Dental
Implant System (SDIS). |
| Compatible
Implants | Straumann TLX implants
having the NT, RT and
WT 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 NNC
implant-to-abutment
interface geometries.
Straumann BLX implants
having the RB/WB and
WB 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. | Nobel Biocare - Replace,
Active, and Branemark
Straumann - Synocta and
Bone Level
Dentsply Sirona Implants -
Osseospeed, Xive,
Osseospeed EV, and
Ankylos
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 implants
having the NC and
RC implant-to-
abutment interface
geometries.
Straumann Tissue
Level implants
having the NNC,
RN, and WN
implant-to-abutment
interface
geometries. | Straumann TLX implants having the NT,
RT and WT implant-to-abutment
interface geometries. |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
| K Number | | K192742 | K151324 | K181520 | K142890 | K200586 |
| Compatible
Restoration
Materials | Ivoclar IPS e.max CAD
(S and L) - K132209 | Sirona inCoris Zi meso
(S and L) - K181520
Ivoclar IPS e.max CAD
(S and L) - K132209
Straumann n!ce Glass
Ceramic A14 Blocks (L) -
K171773 | Sirona inCoris Zi (L) -
K062509 and K123664
Ivoclar IPS e.max CAD
(S and L) - K132209
Ivoclar TelioCAD (S and
L) - K093708 | Sirona inCoris Zi (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) | Digital Workflow:
polycon® ae (temporary)
zerion LT (permanent) |
| Coronal
Diameters | NT
2.98 mm (Size S)
RT:
3.38 mm (Size L)
WT
3.38 mm (Size L) | 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 | NT
2.80 mm (3.9 mm diameter platform)
RT
3.30 mm (5.05 mm diameter platform)
WT
3.30 mm (7.00 mm diameter platform) |
| Abutment
Platform
Diameters | NT 4.0 mm
RT 5.0 mm
WT 7.0 mm | 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 | NT 3.9 mm
RT 5.05 mm
WT 7.0 mm |
| FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE
DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | REFERENCE
DEVICE | REFERENCE DEVICE |
| K Number | | K192742 | K151324 | K181520 | K142890 | K200586 |
| Stock Titanium
Base Material | Titanium alloy
(Ti-6Al-7Nb or TAN) | 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) |
| 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
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 traditional or
CARES CAD/CAM digital workflow. |
| Maximum
Angulation | 20° controlled in design
software | 20° controlled in design
software | 20° controlled in design
software | 20° controlled in design
software | 30° | 30° |
| Software | Sirona CEREC Software
Version 5.2.4 | 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 | 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® TLX Variobase® C
510(k) Summary
8
Straumann® TLX Variobase® C
510(k) Summary
9
Straumann® TLX Variobase® C
510(k) Summary
Table 2 – Comparison of subject device versus primary predicate device –
10
Straumann® TLX Variobase® C
510(k) Summary
Performance Testing
Dynamic fatique and static strength tests were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated that the Straumann®TLX Variobase® C abutments are equivalent to the predicate and reference devices.
The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.
The sterilization process for the Straumann® TLX 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".
Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the Sirona Dental CAD/CAM System. Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the top half component of the two-piece abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
Conclusion
The documentation submitted in this premarket notification demonstrates the Straumann® TLX Variobase® C abutments are substantially equivalent to the primary predicate and reference devices.