(155 days)
No
The description mentions CAD/CAM and software for generating digital models, but there is no mention of AI or ML being used in the design or manufacturing process.
No
The device is a dental prosthetic reconstruction (bridges and bars) that attaches to implants to restore chewing function, not to treat or diagnose a disease or condition.
No
The device is described as providing support for prosthetic reconstructions and restoring chewing function, which are therapeutic and restorative purposes, not diagnostic.
No
The device description clearly states that the device is a physical product (bridges and bars made of coron and titanium) that is designed using software (CAD) and manufactured using CAM techniques. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Straumann® CARES® Screw-retained Bridges and Bars are physical devices designed to be implanted in the mouth to support dental prosthetics and restore chewing function. They are not used to analyze biological samples.
- Intended Use: The intended use clearly describes a restorative dental application, not a diagnostic one.
Therefore, this device falls under the category of a medical device, specifically a dental prosthetic component, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
Product codes
NHA
Device Description
The Straumann® CARES Screw-Retained Bridges and Bars ("SRBB") are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms (Figure 1). The purpose of this premarket notification is to expand the currently cleared abutment-to-implant interfaces to include the BLX implant system of the Straumann Dental Implant System (SDIS). The materials available include coron and titanium.
SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e., they are designed by a dental professional (clinician or dental technician) and fabricated by Straumann specifically for an individual patient.
SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Straumann® CARES® Visual software includes the ability to generate digital restoration models incorporating the subject devices as well as the predicate devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing has been conducted:
- Dynamic fatigue testing conforming to FDA guidance (referenced above) and ISO 14801
- o The test environment was 0.9% NaCl at 37°
- Software validation conforming to the requirements of IEC 62304 .
- . Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2
- . Biocompatibility testing according to ISO10993-1
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
June 26, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K190097
Trade/Device Name: Straumann® CARES® Screw-Retained Bridges and Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 10, 2019 Received: April 11, 2019
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190097
Device Name
Straumann® CARES® Screw-Retained Bridges and Bars
Indications for Use (Describe)
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screwretained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
| 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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3
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
5 510(k) Summary
Submitter 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
| 60 Minuteman Road | |
|---|---|
| Andover, MA 01810 | |
|---|---|
| Phone Number: | +1 978 747 5209 |
| Fax Number: | +1 978 747 0023 |
| Contact Person: | Jennifer M. Jackson, MS |
| Director, Regulatory Affairs | |
| Prepared By: | Dr. Gordon Dodds |
| Manager Design Control QM, etkon GmbH |
Date of Submission: June 14, 2019
5.2 Device
| Trade Name: | Straumann® CARES® Screw-Retained Bridges and Bars |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Classification Panel: | Dental Devices |
Predicate Device 5.3
| Primary Predicate: | K132844 - Straumann CARES Bone Level Screw-Retained Bars,
Straumann CARES Bone Level Screw-Retained Bridges |
|--------------------|----------------------------------------------------------------------------------------------------------------|
| Reference Devices: | K173961 – Straumann BLX Implant System
K150203 – Medentika CAD/CAM Abutments |
4
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
Device Description 5.4
The Straumann® CARES Screw-Retained Bridges and Bars ("SRBB") are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms (Figure 1). The purpose of this premarket notification is to expand the currently cleared abutment-to-implant interfaces to include the BLX implant system of the Straumann Dental Implant System (SDIS). The materials available include coron and titanium.
SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e., they are designed by a dental professional (clinician or dental technician) and fabricated by Straumann specifically for an individual patient.
SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Straumann® CARES® Visual software includes the ability to generate digital restoration models incorporating the subject devices as well as the predicate devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)techniques.
Image /page/4/Picture/7 description: The image shows examples of dental bars and bridges. The top row shows three different types of dental bridges. The bottom row shows different types of dental bars and bridges, including basic fixed bar, advanced fixed bar, bridge, dolder bar u-shape/dolder bar egg shape, ackerman bar, MP clip, round bar, and milled bar.
Figure 1 - Straumann® CARES® Screw-Retained Bridges and Bars
5.5 Indications for Use
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such
5
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
Technological Characteristics 5.6
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The change to the previously cleared primary predicate SRBBs is to add the BLX implant-to-abutment interface. No other technological changes (e.g., design parameters, process, materials, etc.) have been made as compared to the primary predicate other than the additional implant-toabutment connection interface (BLX). The indications for use statement for the subject devices has been modified from the primary predicate to clarify the implant-to-abutment interfaces included. The reference devices (K173961) are included for comparison of the BLX interface. The reference devices (K150203) are included for comparison of the dynamic fatique performance.
6
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICES | |
|---|---|---|---|---|
| Straumann CARES ® Screw- | ||||
| Retained Bridges and Bars | K132844 | |||
| Straumann® CARES® Bone | ||||
| Level Screw-Retained | ||||
| Bars/Bridges | K173961 | |||
| Straumann BLX Implant | ||||
| System | K150203 | |||
| Medentika CAD/CAM Abutments | ||||
| Indications for | ||||
| Use | Straumann® CARES® Screw- | |||
| retained Bridges and Bars are | ||||
| indicated for use as bars and | ||||
| bridges that attach to implants to | ||||
| provide support for prosthetic | ||||
| reconstructions such as bridges | ||||
| and overdentures. The final | ||||
| processed products have the | ||||
| purpose of restoring chewing | ||||
| function. | ||||
| Straumann® CARES® Screw- | ||||
| retained Bridges and Bars are | ||||
| indicated for screw-retained | ||||
| restorations. | ||||
| Straumann® CARES® Screw- | ||||
| retained Bridges and Bars are | ||||
| designed to interface with the Bone | ||||
| Level (BL), Tissue Level (TL), and | ||||
| BLX implants of the Straumann | ||||
| Dental Implant System (SDIS). | Straumann CARES Screw- | |||
| Retained Bridges and Bars are | ||||
| indicated for use as bars and | ||||
| bridges that attach to implants of | ||||
| the Straumann Dental Implant | ||||
| System (SDIS) to provide support | ||||
| for prosthetic reconstructions such | ||||
| as bridges and over-dentures. The | ||||
| final processed products have the | ||||
| purpose of restoring chewing | ||||
| function. | ||||
| Straumann CARES Screw- | ||||
| Retained Bridges and Bars are | ||||
| indicated for screw-retained | ||||
| restorations. | Straumann® Variobase® prosthetic | |||
| components directly or indirectly | ||||
| connected to the endosseous | ||||
| dental implant are intended for use | ||||
| as an aid in prosthetic | ||||
| rehabilitations. The prosthetic | ||||
| restoration (crowns) can be | ||||
| cemented onto the Straumann® | ||||
| Variobase® prosthetic components. | ||||
| A temporary restoration can be | ||||
| used prior to the insertion of the | ||||
| final components to maintain, | ||||
| stabilize and shape the soft tissue | ||||
| during the healing phase; they must | ||||
| be placed out of occlusion. Final | ||||
| abutments and restorations may be | ||||
| placed into occlusion when the | ||||
| implant is fully osseointegrated. All | ||||
| digitally designed copings and/or | ||||
| crowns for use with the Straumann® | ||||
| Variobase® Abutment system are | ||||
| intended to be sent to Straumann | ||||
| for manufacture at a validated | ||||
| milling center. | Medentika TiBase CAD/CAM Abutments are intended for | |||
| use with dental implants as a support for single or multiple | ||||
| tooth prostheses in the maxilla or mandible of a partially or | ||||
| fully edentulous patient. | ||||
| Implant System Compatibility Series Implant Diameter | ||||
| (mm) Platform Diameter (mm) | ||||
| Nobel Biocare Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5, | ||||
| 4.3, 5.0, 6.0 | ||||
| Nobel Biocare NobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3), | ||||
| 3.9 (5.0) | ||||
| Biomet 3i Osseotite® Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0 | ||||
| Biomet 3i Osseotite® I 3.25, 3.75, 4.0, 5.0 3.4, 4.1, 5.0 | ||||
| Nobel Biocare Brånemark K 3.3, 3.75, 4.0, 5.0 3.5, 4.1, | ||||
| 4.1, 5.1 | ||||
| Straumann Bone Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8 | ||||
| Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5 | ||||
| Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1, 4.7, 6.0 3.5, | ||||
| 4.5, 5.7 | ||||
| Astra Tech OsseoSpeed™ S 3.5, 4.0, 4.5, 5.0 3.5, 4.0, | ||||
| 4.5, 5.0 | ||||
| Dentsply Friadent® Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4, | ||||
| 3.8, 4.5, 5.5 | ||||
| Dentsply Friadent® Ankylos® Y 3.5, 4.5, 5.5, 7.0 3.5, 4.5, | ||||
| 5.5, 7.0 | ||||
| Medentika TiBase is intended for use with the Straumann® | ||||
| CARES® System. All digitally designed abutments for use | ||||
| with Medentika CAD/CAM Abutments are intended to be | ||||
| manufactured at a Straumann® CARES® validated milling | ||||
| center. | ||||
| Material | Restorations: | |||
| Cobalt Chrome Alloy | ||||
| Titanium Grade 4 | Restorations: | |||
| Cobalt Chrome Alloy | ||||
| Titanium Grade 4 | Titanium-Aluminum-Niobium alloy | |||
| (Ti-6Al-7Nb) | Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V) | |||
| Screws: | ||||
| Titanium-Aluminum-Niobium alloy | ||||
| (Ti-6Al-7Nb) | Screws: | |||
| Titanium-Aluminum-Niobium alloy | ||||
| (Ti-6Al-7Nb) | ||||
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICES | |
| Straumann CARES® Screw-Retained Bridges and Bars | K132844 | |||
| Straumann® CARES® Bone Level Screw-Retained Bars/Bridges | K173961 | |||
| Straumann BLX Implant System | K150203 | |||
| Medentika CAD/CAM Abutments | ||||
| Supported | ||||
| Straumann | ||||
| Interfaces | Bone Level - RC,NC | |||
| Tissue Level – RN, WN | ||||
| BLX - RB, WB | Bone Level - RC,NC | |||
| Tissue Level – RN, WN | BLX - RB, WB | Bone Level - RC,NC | ||
| Tissue Level – RN, WN | ||||
| SRBB | ||||
| Abutment | ||||
| Implant/ | ||||
| Apical | ||||
| Design | BL external cone | |||
| TL internal cone | ||||
| BLX internal cone | BL external cone | |||
| TL internal cone | Not applicable | Not applicable | ||
| Restoration | ||||
| Types | ||||
| Supported | Bridges and Bars from 2 units to | |||
| full-arch | Bridges and Bars from 2 units to | |||
| full-arch | Not applicable | Not applicable | ||
| Design | ||||
| Workflow | CAD | CAD | CAD | CAD |
| Manufacturing | ||||
| Workflow | Straumann Milling Center | Straumann Milling Center | Straumann Milling Center | Straumann Milling Center |
| Design | ||||
| Software | Straumann CARES Visual | Straumann CARES Visual | Straumann CARES Visual | Straumann CARES Visual |
| Design Limits | ||||
| for Bridges | Critical geometry parameters are | |||
| enforced by CARES Visual limits | Critical geometry parameters are | |||
| enforced by CARES Visual limits | Not applicable | Not applicable | ||
| Design Limits | ||||
| for Bars | Critical geometry parameters are | |||
| enforced by CARES Visual limits | Critical geometry parameters are | |||
| enforced by CARES Visual limits | Not applicable | Not applicable | ||
| Sterilization | Steam autoclave | Steam autoclave | Steam autoclave | Steam autoclave |
| Mode of | ||||
| Action | Screw-retained | Screw-retained | Cement-retained | |
| Screw-retained | Cement-retained | |||
| Screw-retained | ||||
| Reusable | No | No | No | No |
7
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
Table 1 – Comparison of technological features
8
Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
5.7 Performance Data
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance 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:
- Dynamic fatigue testing conforming to FDA guidance (referenced above) and ISO 14801
- o The test environment was 0.9% NaCl at 37°
- Software validation conforming to the requirements of IEC 62304 .
- . Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2
- . Biocompatibility testing according to ISO10993-1
Conclusion 5.8
.
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.