(103 days)
No
The summary describes a digital workflow for designing and milling dental restorations using CAD/CAM software and milling machines. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on a validated workflow and the accuracy of the milling process.
No
Explanation: The device is a workflow and system for digitally designing and fabricating patient-specific dental abutment restorations, which are prosthetic devices, not therapeutic devices.
No.
This device is a system for fabricating dental restorations (patient-specific abutments) and does not perform diagnosis of a medical condition.
No
The device is described as a "Validated Workflow" that integrates multiple components including CAD software, CAM software, pre-milled abutment blanks, milling machines, and associated tooling and accessories. While it includes software components (CAD and CAM), it is not solely software and relies on physical hardware (milling machines, blanks, etc.) for its function.
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 patient-specific abutment restorations for dental implants. This is a manufacturing process for a medical device (the abutment), not a diagnostic test performed on a biological sample to provide information about a patient's health.
- Device Description: The device description focuses on the digital workflow for designing and milling dental prosthetics. It involves scanning, CAD/CAM software, milling machines, and material blanks. This is a manufacturing process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The input is anatomical data (scans of the mouth), and the output is a physical dental restoration.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow 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, pre-milled abutment blanks, milling machines and associated tooling and accessories.
Product codes
NHA, PNP
Device Description
The Straumann InLab Validated Workflow is similar to the primary predicate K171649. It employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The 3Shape 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. When choosing the Straumann Validated workflow, the user will only see the available and cleared components which were tested and demonstrated as part of the validated workflow. The milling command file is encrypted prior to transfer to the Roland DWX-42W Plus milling System; this encryption ensures that files generated using other CAD or CAM software cannot be used with the Straumann InLab Validated Workflow. The user will then load the milling command file into the Roland DWX-42W Plus milling System where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
This premarket notification includes restorations (one-piece metal patient-specific abutment restorations) manufactured from various Pre-milled Abutment Blanks (PMABs) from the Straumann Group companies : Institut Straumann AG and Neodent PMABs. The digital workflow using the Straumann InLab Validated Workflow includes the use of the following products:
Dental Scan of the patient's situation
The Straumann InLab Validated Workflow can accept files created by scanners that generate STL files which represent the patient's mouth situation using the following Intraoral or Desktop scanners : 3Shape Trios 5, 3Shape Trios 3, Allied Star SIRIOS, Medit T500. The dental scanner takes optical impressions that document the topographical characteristics of teeth or master models. This includes the location and orientation of dental implants or abutments when a Scanbody is employed during scan.
CAD Software
Under the Straumann InLab Validated Workflow, 3Shape Abutment Designer CAD Software is used as dental CAD applications 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 milling blank. The use of the Straumann Group manufacturers provided digital device models assures the accuracy of the interfaces between the designed restoration and the abutment or implant being restored.
CAM Module
The CAM interface software 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 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 Straumann InLab Validated Workflow. This is a means of assuring that only the validated product configuration is used.
Milling System
The Roland DWX-42W Plus milling machine receives the CAM file from the CAM software. The user will load the CAM file into the Roland machine where it is decoded. The user mounts the appropriate dental material blank, tools and burs. The user will also employ the recommended 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.
Abutment Milling Blanks
This submission also introduces a selection of milling blanks which are available for use with the Straumann InLab Validated Workflow. The materials and their design control limits are identified in Table 23.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression files, scan files from Intra-Oral Scanners or Extra-Oral Scanners
Anatomical Site
Partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals, laboratory settings (milling in the laboratory).
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
Performance Testing – Bench
- Dynamic Fatigue: The device design and performance testing 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".
- Milling Accuracy: A black-box validation was performed to confirm that the dimensions of the milled restoration are the same as the intended CAD design. This test showed that the data sent from the CAD software to the CAM module, sent to the mill, and used to control the milling process results in accurately milled restorations that meet the design intent of the dental technician. The accuracy requirement was met considering the tool's expected lifetime.
- Simulated Use Validation: A simulated use validation of the Straumann InLab Validated Workflow was conducted to confirm that the relevant pre-milled abutment blanks with Medentika Holder components, along with their respective design constraints and workflow restrictions, are correctly implemented (adequately written and locked into the compatible design software and available libraries) within the workflow.
- Simulated implant-abutment connection protection test: Conducted to mitigate the potential risk of damaging the implant-abutment connection geometry during the milling of the patient-matched portions of the abutment blanks, ensuring safety and performance.
Sterilization Validation and Shelf Life: The Pre-milled Abutment Blanks are provided non-sterile and need to be sterilized by moist heat (steam) after milling. The recommended sterilization method has been validated according to ISO 17665-1 and applicable FDA guidance. The methods are equivalent to predicate devices.
Biocompatibility Testing: Biological assessment performed according to ISO 10993-1 and FDA Guidance document. No new issues regarding biocompatibility were raised as materials and manufacturing processes are equivalent to predicate devices.
Electromagnetic Compatibility: No significant changes from currently marketed predicate devices, thus no new issues of electromagnetic compatibility are raised, and the devices can be considered MR Conditional.
Key Metrics
Not Found
Predicate Device(s)
K171649 - Straumann® CARES M-Series CADCAM System
Reference Device(s)
K150899 Straumann CARES Titanium Alloy (TAN) Abutment, K180536 Neodent Implant System GM Line (GM Exact Titanium Block for Medentika Holder), K233857 Neodent Implant System Custom Abutments, K231072 - Anthogyr Flexibase for Axiom BL, K200586 Straumann TLX Implant System, K190040 Straumann BLX Line Extension New Abutments, K151455 3SHAPE ABUTMENT DESIGNER™ SOFTWARE., K190662 MRI Compatibility for Existing Straumann Dental Implant Systems, K182620 MRI Compatibility for Existing Neodent Implant System
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 shows 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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
February 19, 2025
Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K243478
Trade/Device Name: Straumann InLab Validated Workflow Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: November 5, 2024 Received: January 24, 2025
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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 -S
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Straumann InLab Validated Workflow
Indications for Use (Describe)
Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow 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, pre-milled abutment blanks, milling machines and associated tooling and accessories.
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)
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4
Straumann InLab Validated Workflow
510(k) Summary
10 510(k) Summary
10.1 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-Merian-Weg 12
4052 Basel, Switzerland
And : JJGC Indústria e Comércio de Materiais Dentários AS
(dba Neodent)
Av. Juscelino Kubitschek de Oliveira, 3291
Curitiba, Paraná, Brazil 81270-200 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Olivier Russo
Associate Director Regulatory Affairs
Institut Straumann AG
Phone number: +41 61 965 1260 |
| Date of Submission: | February 19, 2025 |
10.2 Name of the Device
| Trade Names: | Straumann InLab Validated Workflow |
|---|---|
| Common Name: | Straumann InLab Validated Workflow |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification : | II |
| Product Code(s): | NHA |
| Secondary Product Code: | PNP |
| Classification Panel: | Dental, dental abutment design software for dental |
| laboratory | |
| Proprietary Name: | Straumann InLab Validated Workflow |
5
Straumann InLab Validated Workflow
510(k) Summary
10.3 Predicate Device(s)
Primary Predicate:
-
. K171649 - Straumann® CARES M-Series CADCAM System
Reference Devices: -
K150899 Straumann CARES Titanium Alloy (TAN) Abutment ●
-
K180536 Neodent Implant System GM Line (GM Exact Titanium Block for . Medentika Holder)
-
K233857 Neodent Implant System Custom Abutments ●
-
K231072 - Anthogyr Flexibase for Axiom BL
-
K200586 Straumann TLX Implant System ●
-
K190040 Straumann BLX Line Extension New Abutments ●
-
K151455 3SHAPE ABUTMENT DESIGNER™ SOFTWARE. .
-
K190662 MRI Compatibility for Existing Straumann Dental Implant Systems .
-
K182620 MRI Compatibility for Existing Neodent Implant System ●
10.4 Device Description
The Straumann InLab Validated Workflow is similar to the primary predicate K171649. It employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The 3Shape 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. When choosing the Straumann Validated workflow, the user will only see the available and cleared components which were tested and demonstrated as part of the validated workflow. The milling command file is encrypted prior to transfer to the Roland DWX-42W Plus milling System; this encryption ensures that files generated using other CAD or CAM software cannot be used with the Straumann InLab Validated Workflow. The user will then load the milling command file into the Roland DWX-42W Plus milling System where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
6
Straumann InLab Validated Workflow
510(k) Summary
This premarket notification includes restorations (one-piece metal patient-specific abutment restorations) manufactured from various Pre-milled Abutment Blanks (PMABs) from the Straumann Group companies : Institut Straumann AG and Neodent PMABs. The digital workflow using the Straumann InLab Validated Workflow includes the use of the following products:
Dental Scan of the patient's situation
The Straumann InLab Validated Workflow can accept files created by scanners that generate STL files which represent the patient's mouth situation using the following Intraoral or Desktop scanners : 3Shape Trios 5, 3Shape Trios 3, Allied Star SIRIOS, Medit T500. The dental scanner takes optical impressions that document the topographical characteristics of teeth or master models. This includes the location and orientation of dental implants or abutments when a Scanbody is employed during scan.
CAD Software
Under the Straumann InLab Validated Workflow, 3Shape Abutment Designer CAD Software is used as dental CAD applications 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 milling blank. The use of the Straumann Group manufacturers provided digital device models assures the accuracy of the interfaces between the designed restoration and the abutment or implant being restored.
CAM Module
The CAM interface software 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 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 Straumann InLab Validated
7
Straumann InLab Validated Workflow
510(k) Summary
Workflow. This is a means of assuring that only the validated product configuration is used.
Milling System
The Roland DWX-42W Plus milling machine receives the CAM file from the CAM software. The user will load the CAM file into the Roland machine where it is decoded. The user mounts the appropriate dental material blank, tools and burs. The user will also employ the recommended 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.
Abutment Milling Blanks
This submission also introduces a selection of milling blanks which are available for use with the Straumann InLab Validated Workflow. The materials and their design control limits are identified in Table 23.
| Straumann
Group
Brand | Material | Minimum
Post
Height
(mm) | Maximum
Angulation | Minimum
Wall
Thickness
(mm) | Gingiva
Height
(mm) | Abutment
Diameter
(mm) |
|-----------------------------|----------------------------------------------------|-----------------------------------|-----------------------|--------------------------------------|---------------------------|------------------------------|
| Straumann
PMABs | TAN (Ti-6Al-
7Nb) | 4.0 | 30° | 0.5 | 0.58 to
8.95 | 2.87 to
15.8 |
| Neodent
PMABs | Ti6Al4V-ELI -
ASTM F136.
Titanium
Grade 5 | 4.0 | 30° | 0.5 | 0.6 to
8.6 | 2.52 to
15.8 |
Table 23 - Materials with design control limits for use under the Straumann InLab Validated Workflow
Note: The "Minimum Post Height" is the "length above the abutment collar / gingival height".
Image /page/7/Picture/11 description: The image shows two different PMABs, one from Straumann and one from Neodent. The Straumann PMAB is a cylindrical metal object with a slot on top and two parallel lines on the side. The Neodent PMAB is also a cylindrical metal object, but it has a small nozzle on one end and the letters "GM" printed on the side.
Figure 16 – Example Images of Straumann Group's Available PMABs
8
Straumann InLab Validated Workflow
510(k) Summary
10.5 Intended Use
The Straumann InLab Validated Workflow is intended for the design and manufacture of patient-specific dental restorations, for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement and screw retained restorations. Pre-milled Abutment Blanks are intended to be further processed by dental professionals with suitable expertise and milling systems to produce custom-made medical devices. Pre-milled Abutment Blank have a pre-fabricated connection that engages directly to the implant. The implant engaging part and screw-seat/channel of the Pre-Milled Abutment Blank is pre-manufactured and is not modified by the milling in the laboratory.
10.6 Indications for Use
Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow 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, pre-milled abutment blanks, milling machines and associated tooling and accessories.
10.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table:
9
Straumann InLab Validated Workflow
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERNCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
|---|---|---|---|---|---|
| K Number | 510(k) Number not yet know | K171649 - Straumann® CARES M-Series | |||
| CADCAM System | K150899 - Straumann CARES | ||||
| Titanium Alloy (TAN) Abutment | K180536 - Neodent Implant System - GM Line | ||||
| (GM Exact Titanium Block for Medentika Holder) | K233857 - Neodent | ||||
| Indications for | |||||
| Use | Patient-specific abutment restorations, | ||||
| milled from Pre-milled Abutment Blanks | |||||
| (PMABs), are indicated for single tooth | |||||
| replacement and multiple tooth | |||||
| restorations. They are directly connected | |||||
| to various endosseous dental implant | |||||
| systems using a basal screw. Patient- | |||||
| specific abutment restorations milled | |||||
| from Pre-milled Abutment Blanks are to | |||||
| be digitally designed and milled using | |||||
| the Straumann InLab Validated | |||||
| Workflow. The Straumann InLab | |||||
| Validated Workflow 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, pre-milled abutment blanks, | |||||
| milling machines and associated tooling | |||||
| and accessories. | 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. | The GM Exact Titanium Block for Medentika Holder | ||||
| is a titanium abutment used in fabricating a fully | |||||
| custom abutment, which is then placed onto | |||||
| Neodent dental implants to provide support for | |||||
| customized prosthetic restorations. The GM Exact | |||||
| Titanium Block for Medentika Holder abutments are | |||||
| indicated for screw-retained single restorations or | |||||
| cement-retained single or multi-unit restorations. All | |||||
| digitally designed abutments for use with the GM | |||||
| Exact Titanium Block for Medentika Holder are | |||||
| intended to be sent to Straumann for manufacture at | |||||
| a validated milling center. | The Custom Abutment | ||||
| prosthetic abutment | |||||
| onto dental implants to | |||||
| prosthetic restorations. | |||||
| digitally designed and | |||||
| CAD/CAM software. | |||||
| Custom Abutments are | |||||
| retained single res | |||||
| multiple restorations | |||||
| with the Custom Al | |||||
| sent to Straumann | |||||
| center. | |||||
| Source of Input | |||||
| Files | Intra-Oral Scanner | ||||
| Bench-top Scanners | Intra-Oral Scanner | ||||
| Bench-top Scanners | N/A | N/A | N/A | ||
| Bench Scanner | |||||
| Control | Yes | Yes | N/A | N/A | N/A |
| Implant | |||||
| Detection | Yes, using Scanbodies | Yes, using Scanbodies | N/A | N/A | N/A |
| Design | |||||
| Environment | 3Shape Abutment Designer Software | ||||
| CAD Software: | |||||
| Closed CAD System facilitating the | |||||
| design of restorations used in | |||||
| conjunction with the devices of various | |||||
| Dental Implant Systems. | Straumann CARES Visual: | ||||
| Closed CAD System facilitating the design of | |||||
| restorations used in conjunction with the | |||||
| devices of the Straumann Dental Implant | |||||
| System (SDIS). | Straumann CARES Visual: | ||||
| Closed CAD System facilitating the | |||||
| design of restorations used in | |||||
| conjunction with the devices of the | |||||
| Straumann Dental Implant System | |||||
| (SDIS). | Straumann CARES Visual | Straumann CARES Visual | |||
| Restoration | |||||
| Types Supported | Device-borne: | ||||
| Solid Abutments for various Dental | |||||
| Implant Systems. | 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 Abutments for Straumann Implants | Device-borne: | ||||
| Solid Abutments for Straumann Implants | Device-borne: | ||||
| Solid Abutments for Neodent Implants | Device-borne: | ||||
| Solid Abutments for | |||||
| Morse taper interface | |||||
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERNCE DEVICE | REFERENCE DEVICE | REFERENCE DEVICE |
| K Number | 510(k) Number not yet know | K171649 - Straumann® CARES M-Series | |||
| CADCAM System | K150899 - Straumann CARES | ||||
| Titanium Alloy (TAN) Abutment | K180536 - Neodent Implant System - GM Line | ||||
| (GM Exact Titanium Block for Medentika Holder) | K233857 - Neodent | ||||
| Compatible | |||||
| Implants | Straumann PMABs: | ||||
| • Straumann Tissue Level implants | |||||
| having the RN, WN, RT and WT | |||||
| implant-to-abutment interface | |||||
| geometries | |||||
| • Straumann Bone Level implants | |||||
| having the NC, RC, RB, WB implant- | |||||
| to-abutment interface geometries |
Neodent PMABs:
• Neodent Implant having the GM and
CM 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, 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 | Neodent GM implants | Neodent GM implants
Neodent NGM implants
Neodent HS implants |
| Abutment
Platform
Diameters | 3.3 - 7 mm | 3.8 - 7.0 mm | 3.8 – 7.0 mm | 3.5 – 7 mm | 3.5 - 4.5 mm |
| Abutment
Material | Titanium alloy (Ti-6Al-7Nb, TAN)
Ti6Al4V, medical grade 5, conforming
ASTM F 136 | Titanium alloy
(Ti-6Al-7Nb, TAN) | Titanium alloy
(Ti-6Al-7Nb, TAN) | Ti6Al4V, medical grade 5, conforming ASTM F 136 | Ti6Al4V, medical grade |
| Maximum
Angulation | 30° controlled in design software | 30° controlled in design software | 30° controlled in design software
(Note : NC and RN Ø3.3 prosthetic
platforms are not indicated for
restorations requiring angulation
correction) | 30° controlled in design software | 30° controlled in design software |
| Minimal wall
thickness | 0.5mm | 0.4mm | 0.4mm | 0.4mm | 0.4mm |
| Gingiva height | For Straumann
RN, WN interface: n/a, tissue level
implant system, GH is given by the
implant design
NC, RC interface: 0.87 - 8.87 mm
NT, RT, WT interface: n/a, tissue level
implant system, GH is given by the
implant design
RB/WB Interface: 0.95 - 8.95 mm
WB Interface: 0.58 - 5.98 mm
For Neodent
NGM interface: 0.6 - 8.6 mm
HS interface: n/a, tissue level implant
system, GH is given by the implant
design **
GM interface: 0.6 - 8.6 mm
**Helix Short (HS) Implant System,
K223638, is a tissue level implant
system | Minimal Gingiva height 0.87mm
Maximal Gingiva height 17.3 mm | No min/max Gingiva Height was defined
as part of the submission | No min/max Gingiva Height was defined as part of
the submission for the Titanium Block | NGM Customized abutments
HS Customized abutments
GM Customized abutments
GM Customized abutments
5.6mm
**Helix Short (HS)
implant system |
| Minimum Post
Height | 4 mm | N/A (not defined) | N/A (not defined) | N/A (not defined) | 4 mm |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE | REFERNCE DEVICE | REFERENCE DEVICE | REFERENCE DE |
| K Number | 510(k) Number not yet know | K171649 - Straumann® CARES M-Series
CADCAM System | K150899 - Straumann CARES
Titanium Alloy (TAN) Abutment | K180536 - Neodent Implant System - GM Line
(GM Exact Titanium Block for Medentika Holder) | K233857 - Neode |
| Abutment
diameter range | For Straumann
RN, WN interface: 5.13 – 15.8 mm
NC, RC interface: 3.13 – 15.8 mm
NT, RT, WT interface: 4.00 – 15.8 mm
RB, WB Interface: 2.87 - 15.8 mm
For Neodent
NGM interface: 2.52 – 11.5 mm
HS interface: 4.75 – 15.8 mm
GM interface: 3.17 – 15.8 mm | No min/max abutment diameter was defined
as part of the submission | No min/max abutment diameter was
defined as part of the submission | Maximum body diameter is listed in the 510(k)
summary 15.8mm | No min/max abutn
submission |
| Restoration
Sizes | Device-borne:
One-piece patient-specific abutment
restorations milled from PMAB Ø11.5
mm or Ø 16 mm. | Device-borne:
Single crown up to 16-Unit Bridge | Device-borne:
One-piece patient-specific abutment
restorations milled from PMAB Ø11.5
mm or Ø 16 mm. | Device-borne:
One-piece patient-specific abutment restorations
milled from PMAB Ø11.5 mm or Ø 16 mm. | Device-borne:
One-piece patient.
PMAB Ø11.5 mm |
| CAD to CAM
Transfer | Seamless, same software interface | Seamless, same software interface | Seamless, same software interface | Seamless, same software interface | Seamless, same s |
| CAM Capability | Selection of tools, tool paths, speeds
and feed rates that the mill uses to
produce an accurate restoration.
Encryption of milling file. | Nesting of multiple designs to maximize use
of material disks.
Selection of tools, tool paths, speeds and
feed rates that the mill uses to produce an
accurate restoration.
Encryption of milling file. | Validated centralized milling center | Validated centralized milling center | Validated centraliz |
| CAM to Mill
Transfer | The encrypted file format ensures that
the milling equipment accepts files
generated by the Straumann Validated
workflow without allowing them to be
altered. | Encrypted file format assures that the M-
Series Mills can only accept files generated
by the Straumann CARES Visual and CAM
Module Software | Validated centralized milling center | Validated centralized milling center | Validated centraliz |
| Supported
Milling System | Roland DWX-42W Plus milling System | Straumann CARES M-Series Mills | Validated centralized milling center | Validated centralized milling center | Validated centraliz |
| Fabrication
Workflow | InLab Milling Workflow :
Wet milling of Ti-6Al-7Nb and Titanium
Grade 5 Pre-Milled Abutment Blanks | InLab Milling 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. | Validated centralized milling center :
Wet milling of Ti-6Al-7Nb Pre-Milled
Abutment Blanks | Validated centralized milling center :
Wet milling of Titanium Grade 5 Pre-Milled Abutment
Blanks | Validated centraliz
Wet milling of Tita |
| 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-steri
to implantation. |
VICE
nt Implant System – Custom Abutments
ment Ti with Screw is a customized nt, manufactured in titanium alloy, placed nts to provide support for customized
tions. All abutments are only intended to be and manufactured using specifics are according to digital dentistry workflow.
hts Ti with Screw are indicated for screwestorations or cemented-retained single or ns. All digitally designed abutments for use Abutment Ti with Screw are intended to be
n for manufacturing at a validated milling
S Visual
or Neodent dental implants having the ace.
10
Straumann InLab Validated Workflow
510(k) Summary
VICE
nt Implant System – Custom Abutments
- ants plants
- ants
grade 5, conforming ASTM F 136
design software
abutment 0.6-5.8mm butment 0.2-5.4mm** abutment 0.6-5.8mm abutment with angled screw channel 0.6-
Implant System, K223638, is a tissue level
11
Straumann InLab Validated Workflow
510(k) Summary
VICE
nt Implant System – Custom Abutments
ment diameter was defined as part of the
-specific abutment restorations milled from n or Ø 16 mm.
software interface
zed milling center
zed milling center
zed milling center
zed milling center : nium Grade 5 Pre-Milled Abutment Blanks
rile – terminally sterilized via autoclave prior
12
Straumann InLab Validated Workflow
510(k) Summary
10.8 Performance Testing
10.8.1 Sterilization Validation and Shelf Life
The Pre-milled Abutment Blanks subject devices are provided non-sterile and need to be sterilized by moist heat (steam) after milling into the patient-specific shape by the enduser. The recommended sterilization method has been validated according to ISO 17665-1 and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". The sterilization methods and parameters are equivalent to the primary predicate and reference devices.
10.8.2 Biocompatibility Testing
Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.
The subject devices are equivalent in material and manufacturing processes to the primary predicate and reference devices, therefore, no new issues regarding biocompatibility were raised.
10.8.3 Electromaqnetic Compatibility
There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices, and they can be considered MR Conditional.
10.8.4 Performance Testing - Bench
Dynamic Fatigue
The device design and performance testing submitted or referenced in support of this premarket notification were conducted according to the FDA guidance document
13
Straumann InLab Validated Workflow
510(k) Summary
"Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and are representative of the design and performance of the subject devices.
Milling Accuracy
To mitigate the risk of inaccurate milling, a black-box validation confirming that the dimensions of the milled restoration are the same as the intended CAD design was performed. This test shows that the data sent from the CAD software to the CAM module, sent to the mill and then used to control the milling process results in accurately milled restorations that meet the design intent of the dental technician. The results of this report show that the accuracy requirement was met considering the tool's expected lifetime as specified by the Roland Milling Machine manufacturer.
Simulated Use Validation
A simulated use validation of the Straumann InLab Validated Workflow was conducted. The purpose of this validation is to confirm that the relevant pre-milled abutment blanks with Medentika Holder components, along with their respective design constraints and workflow restrictions, are correctly implemented (adequately written and locked into the compatible design software and available libraries) within the Straumann InLab Validated Workflow.
A simulated implant-abutment connection protection test was conducted to mitigate the potential risk of damaqing the implant-abutment connection geometry during the milling of the patient-matched portions of the abutment blanks. This ensures that the safety and performance of the device are consistently maintained within the Straumann InLab Validated Workflow.
10.9 Conclusion
The conclusion drawn from the nonclinical tests submitted in this premarket notification demonstrates that the Straumann InLab Validated Workflow and submitted Pre-milled Abutment Blanks are substantially equivalent to the primary predicate and reference devices.