(262 days)
No
The summary describes a standard CAD/CAM system for dental restorations, focusing on digital workflow, software for design and CAM, and milling. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is a CAD/CAM system for designing and fabricating dental prosthetics, which are restorative devices, not therapeutic devices.
No
The device is indicated for the design and fabrication of implant-borne prosthetics, not for diagnosing conditions.
No
The device description explicitly states that the system integrates multiple components including CAD software, CAM software, restoration material blanks, milling machines, and associated tooling and accessories. It also mentions the M-Series mill and the loading of dental material blanks, indicating hardware components are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the design and fabrication of dental prosthetics (copings, crowns, bridges, and abutments) for restoring partially or fully edentulous mandibles and maxillae. This is a mechanical and structural application within the body, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description details a system for digital design and fabrication using scanning data, CAD/CAM software, and milling machines. This process is focused on creating physical dental restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
The device is clearly intended for the manufacturing of custom dental implants and prosthetics, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
Product codes
NHA, PNP
Device Description
The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow.
The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories
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
Bench studies were conducted.
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801.
- Software validation conforming to the requirements of IEC 62304.
- Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
- Biocompatibility testing conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-18.
- Electrical safety testing conforming to IEC 61010-1 and IEC 61010-2-010.
Key results: Based upon assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K120822, K133421, K152383, K063511, K151157, K150899, K142890, K170354, K150203
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 22, 2018
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K171649
Trade/Device Name: Straumann CARES M-Series CAD/CAM System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: January 22, 2018 Received: January 23, 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Jennifer Jackson
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,
Mary S. Runner -S
forTina 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 Druq Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K171649
Device Name
Straumann CARES M-Series CAD/CAM System
Indications for Use (Describe)
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
| | Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
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FORM FDA 3881 (8/14)Equivalent
3
510(k) Summary
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810 | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality | | |
| Prepared By: | Gordon Dodds
Manager Design Control QM
Etkon GmbH | | |
| Date Prepared: | February 21, 2018 | | |
| Product Code(s): | NHA (21 CFR 872.3630)
PNP (21 CFR 872.3630) | | |
| Device Class: | II (21 CFR 872.3630) | | |
| Classification Panel: | Dental | | |
| Classification Name: | Endosseous dental abutment (21 CFR 872.3630) | | |
| Proprietary Name: | Straumann® CARES M-Series CAD/CAM System | | |
| Predicate Device(s): | • K111421 SIRONA DENTAL CAD/CAM SYSTEM | | |
| Reference Device(s): | • K120822 Straumann CARES Variobase Abutment
• K133421 Magellan Screw-Retained Abutments
• K152383 Ceramill ZOLID fx
• K063511 Ceramill ZI
• K151157 Variobase for Bridge/Bars
• K150899 Straumann CARES TAN Abutments
• K142890 Straumann Variobase Abutment
• K170354 Straumann Variobase Abutments
• K150203 Medentika CAD/CAM Abutments | | |
| Device Description: | The Straumann CARES M-Series CAD/CAM System is
intended for the design and fabrication of dental restorations by
dental laboratories by means of a digital workflow.
The Straumann CARES M-Series CAD/CAM System employs
optical impression files that document the topographical | | |
4
characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
The supported dental restorative devices are described in the following table:
| Type | Implant-borne | Picture |
|---|---|---|
| Coping1 | Using previously cleared Variobase Abutments | Image: Coping |
| Crown1 | Using previously cleared Variobase Abutments | Image: Crown |
| Bridge1 | Using previously cleared Variobase Abutments | Image: Bridge |
| Abutment | Using subject Pre-Milled Abutment Blank | Image: Abutment |
1 The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses.
5
The digital workflow using the Straumann CARES M-Series CAD/CAM System includes the use of the following products:
Dental Scanner(s)
The Straumann CARES M-Series CAD/CAM can accept files generated using the following devices (note that these are not subject devices to this submission):
- Dental Wings Intra-Oral Scanner, DWIO
- Dental Wings 3-Series & 7-Series desktop scanners (extra-oral)
- Straumann CARES CS2 scanner (extra-oral)
The dental scanner takes optical impressions that document the topographical characteristics of teeth, traditional dental impressions, or stone models. This includes the location and orientation of dental implants or abutments when a Scanbody is employed during the scan.
CARES Visual CAD Software
The CARES Visual software is a dental CAD application that allows the user to digitally design dental restorations, based on information that was acquired by a dental scanner. As a result of the design process and the indication and material dependent dimensional limits, a three-dimensional geometry is created that is linked to the selected restorative material/milling blank. The use of Straumann manufacturer provided digital device models assures the accuracy of the interfaces between the designed restoration and the abutment or implant being restored.
CARES Visual CAM Module
The CAM interface module converts the three-dimensional geometry into milling machine control data. The CAM software uses the digital restoration geometry information and the material selection to define the tools to be used, the paths the tools are to follow to re-create the digital geometry in physical form and the speed and feed rates of the mill and the tooling. The CAM software also allows for multiple restoration files to be fit within the geometry of a single dental material blank (a process referred to as nesting) in order to maximize the use of dental material blanks.
6
The completed CAM file is encrypted prior to being output for transfer to the milling machine. This encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. This is a means of assuring that only the validated product configuration is used.
Straumann M-Series Milling Machine
The milling machine receives the CAM file from the CAM software. The user will load the CAM file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank, tools and burs. For certain materials the user will also employ a cutting fluid that acts as a lubricant and coolant for the milling operation. Once the machine is fully configured, the user initiates the milling operation.
Sintering Furnace
- Straumann Therm ●
Some restoration materials are provided in a green (i.e. partially crystallized) state or are combined with a polymeric binder material. This is typically done to make the machining process easier and to increase tool life. These materials must undergo a sintering process after milling in order to achieve their final form. This is carried out in a sintering furnace.
The materials that require sintering are to be larger than the final finished restoration to account for the shrinkage that will occur during sintering. This scaling is included in the CAD software as a material specific parameter. The CAD software will scale the digital restoration design using this parameter prior to transfer of the data to the CAM software in order to assure that the final, sintered restoration accurately reflects the digital design.
Restoration Material Milling Blanks
A selection of milling blanks is available for use with the Straumann CARES M-Series CAD/CAM system. Straumann will market its own material Straumann® n!ce, Ivoclar's IPS e.max CAD and co-branded versions of milling blanks currently marketed by Amann Girrbach in the United States. These materials and their design control limits are identified in the table below.
7
| Product
Name | Mater
ial | Min post
height
mm | Max
angulati
on | Min
Gingiva
height
mm | Min wall
thickness
mm |
|----------------------|------------------|--------------------------|-----------------------|--------------------------------|-------------------------------------------|
| Zi | ZrO2 | 4.0 | 30° | 1 | 0.6 |
| Zolid HT | ZrO2 | 4.0 | 30° | 1 | 0.6 |
| Zolid SHT | ZrO2 | 4.0 | 30° | 1 | 0.95 |
| Zolid HT
Preshade | ZrO2 | 4.0 | 30° | 1 | 0.6 |
| n!ce | Glass
ceramic | 4.0 | 30° | 1 | 1.05 |
| IPS e.max
CAD | Glass
ceramic | 4.0 | 30° | 1 | 0.75 to
pre-
molar
0.95
molar |
This submission also introduces new milling blanks suitable for fabricating solid customized abutments that attach directly to the implants of the Straumann Dental Implant System. The Pre-Milled Abutment Blank devices are produced from Ti-6Al-7Nb alloy. They have the designated Straumann implant-toabutment connection pre-milled at the apical end of the blank. The emergence profile and coronal segments of the blank consists of a solid cylinder available in one 12 mm diameter. The four configurations and design control limits are shown in the table below.
| Product Name | Material | Implant-to-Abutment Interface | Min post surface area | Max angulation | Min wall thickness mm | Min Gingiva height mm |
|---|---|---|---|---|---|---|
| PMAB | TAN | Bone Level | ||||
| Narrow CrossFit® (NC) | 37 mm2 to 56 mm2 dependent on tooth position | 30° | 0.4 | 0.87 | ||
| PMAB | TAN | Bone Level | ||||
| Regular CrossFit® (RC) | This corresponds to a minimum height of ~4 mm | 30° | 0.4 | 0.87 | ||
| PMAB | TAN | Tissue Level | ||||
| Regular Neck (RN) | 30° | 0.4 | N/A | |||
| PMAB | TAN | Tissue Level | ||||
| Wide Neck (WN) | 30° | 0.4 | N/A |
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The following schematic illustrates how the different components of the CARES M-Series CAD/CAM system work together.
Image /page/8/Figure/2 description: The image shows a diagram of the process for creating dental prostheses. The process starts with a scan file of the patient's dentition, which is used to create a CARES visual design. The design is then sent to an M-Series Mill, which uses a milling blank or a pre-milled abutment blank to create the prosthesis. Finally, the prosthesis is sent to a sinter oven to be completed.
Figure 1 Workflow from scanning to completed prostheses
| Indications For Use: | The Straumann® CARES® M-Series CAD/CAM System is
indicated for the design and fabrication of single or multiple-
unit implant-borne prosthetics for the restoration of partially or
fully edentulous mandibles and maxillae. The system
integrates multiple components of the digital dentistry
workflow: scan files from Intra-Oral Scanners or Extra-Oral
Scanners, CAD software, CAM software, restoration material
blanks, milling machines and associated tooling and
accessories. The system is used to design and fabricate
CAD/CAM milled coping, crown and bridge restorations to be
cemented onto Straumann® Variobase® Abutments, as well as
milled abutments to be affixed to the endosseous dental
implants of the Straumann® Dental Implant System using a
basal screw. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Straumann CARES M-Series CAD/CAM System is
intended to be used for the design and fabrication of patient-
specific dental restorations. The dental restorations are intended
to restore dental implants, either directly (CAD/CAM milled
abutment) or via a Ti-base style abutment (Straumann trade
name Variobase). |
9
The Straumann CARES M-Series CAD/CAM System also supports the design and fabrication of two styles of implantborne dental restorations. Prostheses consist of stock Variobase Abutments (generically known as Ti-bases) with customized ceramic or glass-ceramic restorations cemented in place that mount directly onto Straumann NC, RC, RN and WN implants. The combination of the ceramic restoration and Variobase Abutment component make up a two-piece abutment assembly which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses, see Figure 2 for examples of the Variobase/restoration two-piece combinations.
Image /page/9/Figure/2 description: The image shows two diagrams of dental implants. The diagram on the left shows two implants with a bridge connecting them. The implants are angled up to 30 degrees apart. The diagram on the right shows a single implant with a basal screw, prosthetic restoration, and Straumann Variobase abutment.
Figure 2 Two-piece Straumann® Variobase™ Abutments for Bridges/Bars (left) and Crowns (right)
The Straumann CARES Pre-Milled Abutment Blank (PMAB) is designed and milled to create a customized abutment that engages directly to the implant. The implant engaging part and screw-seat/channel of the CARES Pre-Milled Abutment Blank is already pre-manufactured by Straumann as delivered to the customer and will not be modified by milling in the laboratory, see Figure 3.
Image /page/9/Picture/5 description: The image shows two dental implants. The implant on the left is a cylindrical metal post with a U-shaped notch at the top. The implant on the right is shaped like a tooth with a metal base. Both implants are silver in color and appear to be made of metal.
Figure 3 Left: PMAB with milling machine clamping mechanism at top and pre-milled interface to dental implant at bottom. Right: Patient-specific abutment milled from a blank
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| Milling Blank | Material |
|---|---|
| Pre-Milled Abutment | |
| Blank | TAN (Ti6A7Nb) |
| Ceramill ZOLID fx | |
| (Straumann brand | |
| Zolid SHT) | ZrO2 (YSZ)- Yttria- |
| stabilized zirconia | |
| Ceramill Zi | |
| (Straumann brand | |
| Zolid HT and Zi) | ZrO2 (YSZ) |
| IPS e.max CAD | Lithium-disilicate |
| glass-ceramic | |
| n!ce | Lithium- |
| aluminosilicate with | |
| Lithium-disilicate | |
| glass-ceramic |
Pre-Milled Abutment Blanks are manufactured from titanium-6aluminum-7niobium alloy (TAN). This material is identical to the material used to produce the reference CARES TAN Abutments (K150899).
Technological Characteristics:
Materials:
See Table below
11
Table 1: Substantial Equivalence Comparison – Straumann CARES M-Series CAD/CAM System
| FEATURE | SUBJECT
Straumann® CARES® M-Series
CAD/CAM System | PREDICATE
SIRONA DENTAL CAD/CAM
SYSTEM (K111421) | Equivalence
Discussion |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Straumann CARES M-Series
CAD/CAM System is indicated for the
design and fabrication of single or
multiple-unit implant-borne prosthetics for
the restoration of partially or fully
edentulous mandibles and maxillae. The
system integrates multiple components of
the digital dentistry workflow: scan files
from Intra-Oral Scanners or Extra-Oral
Scanners, CAD software, CAM software,
restoration material blanks, milling
machines and associated tooling and
accessories. The system is used to design
and fabricate CAD/CAM milled coping,
crown and bridge restorations to be
cemented onto Straumann® Variobase®
Abutments, as well as milled abutments to
be affixed to the endosseous dental
implants of the Straumann® Dental
Implant System using a basal screw. | 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 titanium
bases SSO 3.5 Land SBL 3.3 L, the
indication is restricted for 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 mesostructure.
The inCoris mesostructure and TiBase
two-piece abutment is compatible with the
following implants systems:
• Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562)
· Friadent Xive (K013867)
· Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239)
· Zimmer Tapered Screw-Vent (K061410)
· Straumann SynOcta (K061176) | Equivalent
The basic indication of providing support
for prostheses scanning, design and
fabrication is the same.
Support for TiBase-borne restorations is
the same. The subject device indications
refer to fabrication of coping, crowns and
bridges. The proposed copings, crowns
and bridges include the mesostructure (or
top-half of two-piece abutment), which are
the same as referenced in the primary
predicate indications. The crowns and
bridges of the subject device may be
referred to as hybrid abutments and are
therefore equivalent.
The subject device also supports the
fabrication of implant connected solid
abutments. |
| FEATURE | SUBJECT
Straumann® CARES® M-Series
CAD/CAM System | PREDICATE
SIRONA DENTAL CAD/CAM
SYSTEM (K111421) | Equivalence
Discussion |
| | | • Straumann Bone Level (K053088,
K062129, K060958)
• Biomet 3i Certain (K014235, K061629)
• Nobel Biocare Active (K071370) | |
| Source of Input
Files | Intra-Oral Scanner
Bench-top Scanners | Bench-top scanners | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device. |
| Bench Scanner
Control | Yes | Yes | Equivalent |
| Implant Detection | Yes, using Scanbodies | Yes, using Scanbodies | Equivalent |
| Design Environment | Straumann CARES Visual:
Closed CAD System facilitating the design
of restorations used in conjunction with the
devices of the Straumann Dental Implant
System (SDIS). | Sirona Dental CAC/CAM Software
Closed CAD System facilitating the design
of restorations used in conjunction with the
Sirona TiBase devices and Camlog
Titanium Base CAD/CAM devices. | Equivalent
Both systems support the design and
fabrication of device-borne restorations,
but for devices from different companies. |
| Restoration Types
Supported | Device-borne:
Copings and crowns for Variobase
Abutments
Copings, crowns and bridges for Screw-
Retained Abutments
Bridges and bars for Variobase for
Bridge/Bar Abutments
Solid TAN Abutments for Straumann
Implants | Device-borne:
Copings and crowns for TiBase devices
Copings and crowns for Camlog Titanium
Base devices | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device. Both devices allow design and
fabrication of the mesostructure for a two-
piece abutment (standard coping or hybrid
crown/bridge). The subject device also
allows design and fabrication of a one-
piece titanium abutment. The areas of the
abutment available for design are
equivalent. |
| Supported
Hardware Devices | • Straumann Variobase Abutments for
NC, RC, NNC, RN and WN implant-to-
abutment interfaces (K120822).
• Straumann Variobase Abutments for
Bridges and Bars for NC, RC, NNC, RN | • Sirona Ti-bases for use with the
following implant systems:
• Nobel Biocare Replace (K020646)
• Nobel Biocare Branemark (K022562)
• Friadent Xive (K013867)
• Biomet 3i Osseotite (K980549)
• Astra Tech Osseospeed (K091239) | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device related to support for titanium base
style abutments. The subject devices |
| FEATURE | SUBJECT
Straumann® CARES® M-Series
CAD/CAM System | PREDICATE
SIRONA DENTAL CAD/CAM
SYSTEM (K111421) | Equivalence
Discussion |
| | and WN implant-to-abutment interfaces
(K151157)
• Copings for Straumann Screw-Retained
Abutments (K133421).
• Solid abutments for connection with
NC, RC, RN and WN implants of the
SDIS using the subject Pre-Milled
Abutment Blanks. | • Zimmer Tapered Screw-Vent
(K061410)
• Straumann SynOcta (K061176)
• Straumann Bone Level (K053088,
K062129, K060958)
• Biomet 3i Certain (K014235,
K061629)
• Nobel Biocare Active (K071370)
• Camlog Titanium Base CAD/CAM | provide support for implant connected
abutments. |
| Supported
Restorative
Materials | • Ceramill ZOLID fx ZrO2
• Ceramill ZI ZrO2
• Ceramill ZOLID ZrO2
• Titanium-6Aluminum-7Niobium alloy
or TAN (Subject Pre-Milled Abutment
Blanks)
• Ivoclar IPS e.max CAD
• Straumann n!ce Glass Ceramic | • InCoris pre-sintered Ceramic (K062509)
ZrO2 | Equivalent
ZrO2 Ceramic material with indications
according to ISO 6872 Classification are
equivalent. The ZrO2 materials for use
with the Straumann CARES M-Series
CAD/CAM System have been previously
cleared by FDA.
The TAN material is identical to material
used in CARES TAN Abutments cleared
to market per K150899.
Straumann n!ce Blocks for Amann
Girrbach were previously cleared per
K170420.
The use of the Ivoclar IPS e.max CAD
material with Variobase Abutments has
been cleared per K142890.
The use of the n!ce material with
Variobase Abutments has been cleared per
K170354. |
| Restoration Sizes | Device-borne:
Single crown up to 16-Unit bridge | Device-borne:
Single crown | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device.
Support of bridges through two or more
implants is achieved through Variobase for |
| FEATURE | SUBJECT
Straumann® CARES® M-Series
CAD/CAM System | PREDICATE
SIRONA DENTAL CAD/CAM
SYSTEM (K111421) | Equivalence
Discussion |
| Interface to Ti-Base | Milled by the system using solid
restoration material discs or C14 blocks | Pre-milled in the A14 block material | Bridge/Bar abutments (K151157). Use of
multiple implants in the bridge limit the
force on the individual implant to be less
or equivalent to that of the single crown.
For a 16-unit bridge, the force is spread
over 4 or more implants.
Equivalent
The ability of the subject device to use
solid blocks provides greater design
flexibility to the user. |
| CAD to CAM
Transfer | Seamless, same software interface | Seamless, same software interface | Equivalent |
| CAM Capability | Nesting of multiple designs to maximise
use of material discs
Selection of tools, tool paths, speeds and
feed rates that the mill uses to produce an
accurate restoration
Encryption of milling file | Selection of tools, tool paths, speeds and
feed rates that the mill uses to produce an
accurate restoration | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device. |
| CAM to Mill
Transfer | Encrypted file format assures that the M-
Series, Mills can only accept files
generated by the Straumann CARES
Visual and CAM Module software | It would be expected that the transfer is
encrypted - the transfer protection
mechanism is not publically available. | Equivalent
Capabilities of subject device include or
exceed the scope of capabilities for the
predicate device. |
| Supported Mills | Straumann CARES M-Series, Mills | CEREC MCXL Mill
inLab MCXL Mill | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device. |
| Fabrication
Workflow | Dry milling of partially crystallized
ceramic blanks
Wet milling of Ti-6Al-7Nb Pre-Milled
Abutment Blanks, Ivoclar IPS e.max CAD
and n!ce Glass Ceramic using coolant | In-lab wet milling of pre-sintered ceramic
blocks using coolant | Equivalent
Capabilities of subject device include the
scope of capabilities for the predicate
device. |
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| FEATURE | SUBJECT
Straumann® CARES® M-Series
CAD/CAM System | PREDICATE
SIRONA DENTAL CAD/CAM
SYSTEM (K111421) | Equivalence
Discussion |
|---------|---------------------------------------------------------|--------------------------------------------------------|---------------------------|
| | | | |
Table 2: Substantial Equivalence Comparison – Abutment Borne Restorations
| Feature | SUBJECT
Straumann Variobase Abutments | PREDICATE
Straumann Variobase Abutments
(K142890, K120822) | Equivalence Discussion |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Straumann CARES M-Series
CAD/CAM System is indicated for the
design and fabrication of single or
multiple-unit implant-borne prosthetics for
the restoration of partially or fully
edentulous mandibles and maxillae. The
system integrates multiple components of
the digital dentistry workflow: scan files
from Intra-Oral Scanners or Extra-Oral
Scanners, CAD software, CAM software,
restoration material blanks, milling
machines and associated tooling and
accessories. The system is used to design
and fabricate CAD/CAM milled coping,
crown and bridge restorations to be
cemented onto Straumann® Variobase®
Abutments, as well as milled abutments to
be affixed to the endosseous dental
implants of the Straumann® Dental
Implant System using a basal screw. | 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 |
| Ti-base
Material | Titanium-Aluminum-Niobium alloy
(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy
(Ti-6Al-7Nb) | Identical |
| Abutment Diameter | 3.8 – 7.0 mm | 3.8 – 7.0 mm | Identical |
| Abutment Height | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Identical |
| Feature | SUBJECT
Straumann Variobase Abutments | PREDICATE
Straumann Variobase Abutments
(K142890, K120822) | Equivalence Discussion |
| Coping/ Crown
Material | The following materials are being added to
the previously cleared coping/crown
materials:
Amann Girrbach Ceramill ZOLID ZI
(ZrO2)
Amann Girrbach Ceramill ZOLID HT
(ZrO2)
Amann Girrbach Ceramill ZOLID SHT
(ZrO2)
Amann Girrbach Ceramill ZOLID HT
Preshade (ZrO2)
Ivoclar IPS e.max CAD (K142890)
Straumann n!ce Glass Ceramic (K170354) | 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) | Equivalent
The digital workflow is being expanded to
add additional materials.
. The Zi, ZOLID series of materials are
equivalent to the zerion ZrO2 material.
Identical
The use of the n!ce material with
Variobase Abutments is identical to
K170354.
The use of the Ivoclar IPS e.max CAD
with Variobase Abutments is identical to
K142890. |
| Design Workflow | CAD | Wax-up or CAD | Equivalent
The subject device employs a subset of the
techniques employed for the predicate
devices. |
| Fabirication
Workflow | Milling by the dental laboratory | Traditional casting or pressing by the
dental laboratory
or
CAM by Straumann Milling Center | Equivalent
The restorations milled by the dental
laboratory are equivalent to those
produced by the Straumann milling center. |
| Mode of Attachment | Screw-retained or cement retained | Screw-retained or cement retained | Identical |
| Reusable | No | No | Identical |
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| Feature | Subject
Laboratory Milled CARES® TAN
Abutments | Predicate
Straumann® CARES® TAN Abutments
(K150899) | Equivalence
Discussion |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Straumann CARES M-Series
CAD/CAM System is indicated for the
design and fabrication of single or
multiple-unit implant-borne prosthetics for
the restoration of partially or fully
edentulous mandibles and maxillae. The
system integrates multiple components of
the digital dentistry workflow: scan files
from Intra-Oral Scanners or Extra-Oral
Scanners, CAD software, CAM software,
restoration material blanks, milling
machines and associated tooling and
accessories. The system is used to design
and fabricate CAD/CAM milled coping,
crown and bridge restorations to be
cemented onto Straumann® Variobase®
Abutments, as well as milled abutments
to be affixed to the endosseous dental
implants of the Straumann® Dental
Implant System using a basal screw. | The Straumann CARES® TAN abutments
are indicated for single tooth replacement
and multiple tooth restorations. The
prosthetic restoration can be cemented or
directly veneered/ screw-retained. | Identical |
| Abutment
Material | Titanium-Aluminum-Niobium alloy (Ti-
6A1-7Nb, TAN) | Titanium-Aluminum-Niobium alloy (Ti-
6Al-7Nb, TAN) | Identical |
| Abutment Apical
Design | Engaging
BoneLevel
Narrow CrossFit (NC)
Regular CrossFit (RC)
Tissue Level
Regular Neck (RN)
Wide Neck (WN) | Engaging
BoneLevel
Narrow CrossFit (NC)
Regular CrossFit (RC)
Tissue Level
Regular Neck (RN)
Wide Neck (WN) | Identical |
| Feature | Subject
Laboratory Milled CARES® TAN
Abutments | Predicate
Straumann® CARES® TAN Abutments
(K150899) | Equivalence
Discussion |
| Abutment Coronal
Design | CADCAM design process.
Designs controlled by material-specific
design limits in the CARES Visual CAD
software, model verification performed by
the CAM software and milling blank
dimensions used by the Straumann milling
center. | CADCAM design process.
Designs controlled by material-specific
design limits in the CARES Visual CAD
software, model verification performed by
the CAM software and milling blank
dimensions used by the Straumann milling
center. | Identical |
| CAD Design Limits | Max. Angulation
30°
Emergence Offset
0.1 mm
Emergence Angle
65°
Min. Thickness
0.4 mm
Smooth Distance
0.5 mm
Min post surface area
37 to 56mm² | Max. Angulation
30°
Emergence Offset
0.1 mm
Emergence Angle
65°
Min. Thickness
0.4 mm
Smooth Distance
0.5 mm
Min post surface area
37 to 56mm² | Identical |
| Fabrication Method | Dental laboratory mills using the
Straumann CARES M-Series CAD/CAM
Systems and the subject Pre-Milled
Abutment Blank. | CAM by Straumann Milling Center. | Equivalent
Both methods make use of the Straumann
CARES Visual CAD software to design
the abutment, so the same validated limits
are applied. The difference is the
transition from a QSR controlled
manufacturing location to a dental
laboratory.
The milling accuracy of the Straumann
CARES M-Series CAD/CAM System has
been validated. Labeling has been revised
and validated for milling unit installation,
maintenance, and required tools/machine
liquids/material blocks to ensure
equivalence. |
| Directly
Veneerable? | Yes | Yes | Identical |
Table 3: Substantial Equivalence Comparison – Implant-Borne Restorations
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Performance Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Data: Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. The following testing has been conducted and is summarized for each new material and device type in the table below, with reference to predicates:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801.
- Software validation conforming to the requirements of IEC 62304. ●
- Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
- . Biocompatibility testing conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-18.
- Electrical safety testing conforming to IEC 61010-1 and IEC 61010-2-010.
| Variobase
materials | Fatigue tests -
predicates | Sterilization
validation
predicates | Biocompatibility
testing -
predicates |
|------------------------|-------------------------------|-------------------------------------------|---------------------------------------------|
| Zi | K142890 | K142890 | K063511 |
| Zolid HT | K142890 | K142890 | K063511 |
| Zolid SHT | K142890
K150203 | K142890 | K152383 |
| n!ce | K170354 | K170354 | K170354 |
| IPS e.max
CAD | K142890 | K142890 | K142890 |
| PMAB
materials | Fatigue tests
predicates | Sterilization
validation
predicates | Biocompatibility
testing –
predicates |
|-------------------|-----------------------------|-------------------------------------------|---------------------------------------------|
| TAN | K150899 | K150899 | K150899 |
- Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.