(168 days)
No
The device description mentions CAD/CAM technology for design and manufacturing, but there is no mention of AI or ML being used in the design process, analysis, or any other function of the device.
No.
The device is a prosthetic component designed to restore chewing function by supporting prosthetic reconstructions; it does not treat or cure a disease or condition.
No
This device is described as a prosthetic component used for dental rehabilitations, specifically as bars and bridges that attach to implants to provide support for prosthetic reconstructions. Its purpose is to restore chewing function. It does not perform any diagnostic function.
No
The device is a physical medical device (bars and bridges made of titanium) that is designed and fabricated using CAD/CAM software. The software is a tool for designing the physical device, not the medical device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthetic component directly connected to a dental implant to aid in prosthetic rehabilitations and restore chewing function. This is a mechanical and structural function within the body.
- Device Description: The description details the physical nature of the device (titanium bars and bridges) and how they are designed and fabricated for individual patients to interface with dental implants.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any testing of biological samples or providing diagnostic information.
The device is a dental prosthetic component, not a diagnostic tool.
N/A
Intended Use / Indications for Use
CARES® Screw - Retained Bars and Bridges (SRBB)
Indications for Use (Describe)
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. CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations.
CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)):
Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0 Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4 Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0 Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0. 5.0 / Platform 3.4, 4.1. 5.0 Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0 Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1 Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7 Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0 Dentsply Implants - XiVE S / T- Series / Diameter 3.4, 3.8, 4.5, 5.5 / Platform 3.4, 3.8, 4.5, 5.5
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The CARES® Screw Retain Bars and Bridges, referenced in Table 1, are used for the restoration of different dental implants systems with different endosteal diameters, lengths and platforms. The bars and bridges presented in the premarket notification submission (identified as "SRBB" for Screw Retained Bridges and Bars) are designed to interface with different implant connections. They allow for individual customization regarding function and esthetics. They attach directly to dental implants. The devices are intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. Screw Retained Bars and Bridges (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 Medentika specifically for an individual patient. SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Commercial Off-The-Shelf (COTS) Software includes the ability to generate digital restoration models incorporating the subject devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)-techniques. The devices are made entirely of titanium Grade 5 according to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional (clinician or dental technician) within a dental laboratory setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dynamic fatigue testing was 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" and demonstrated that the CARES® Screw - Retained Bars and Bridges are equivalent to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K170838, K180536, K120414, K180564, K150203
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2020
Medentika GmbH % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K201711
Trade/Device Name: CARES® Screw - Retained Bars and Bridges (SRBB) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 5, 2020 Received: November 9, 2020
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name:
CARES® Screw - Retained Bars and Bridges (SRBB)
Indications for Use (Describe)
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. CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations.
CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)):
Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0 Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4 Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0 Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0. 5.0 / Platform 3.4, 4.1. 5.0 Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0 Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1 Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7 Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0 Dentsply Implants - XiVE S / T- Series / Diameter 3.4, 3.8, 4.5, 5.5 / Platform 3.4, 3.8, 4.5, 5.5
Type of Use (Select one or both, as applicable) �Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
510(k) Summary 5
Submitter's Contact Information 5.1
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | On the behalf of: |
| | Medentika GmbH
Hammweg 8-10
76549 Hügelsheim, Germany
Registration No.: 3008770646 Owner/Operator No.: 10034561 |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Email: jennifer.jackson@straumann.com |
| Prepared By &
Alternate Contact: | Olivier Russo
Regulatory Affairs and Compliance Manager
Institut Straumann AG
Phone number: +41 61 965 1260 |
| Date Prepared: | December 8, 2020 |
Name of the Device 5.2
| Trade Names: | CARES® Screw - Retained Bars and Bridges (SRBB) |
|---|---|
| Common Name: | CARES® Screw - Retained Bars and Bridges |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Number: | 21 CFR 872.3630 |
| Device Classification: | II |
| Product Code(s): | NHA |
| Classification Panel: | Dental |
4
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
Predicate Device(s) 5.3 -
Primary Predicate:
-
K190097 Straumann CARES® Screw-Retained Bridges and Bars .
Reference Devices: -
K170838 Medentika CAD/CAM TiBases .
-
K180536 Neodent GM (Grand Morse) implant Line .
-
K120414 OsseoSpeed™ Plus .
-
. K180564 – MRI Safety Information Labeling Change
-
K150203 Medentika CAD/CAM Abutments .
5.4 Device Description
The CARES® Screw Retain Bars and Bridges, referenced in Table 1, are used for the restoration of different dental implants systems with different endosteal diameters, lengths and platforms. The bars and bridges presented in the premarket notification submission (identified as "SRBB" for Screw Retained Bridges and Bars) are designed to interface with different implant connections. They allow for individual customization regarding function and esthetics. They attach directly to dental implants. The devices are intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. Screw Retained Bars and Bridges (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 Medentika specifically for an individual patient. SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Commercial Off-The-Shelf (COTS) Software includes the ability to generate digital restoration models incorporating the subject devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)-techniques. The devices are made entirely of titanium Grade 5 according to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
5
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
| Reference | Product Description | BRIDGE / BAR SYSTEM |
|---|---|---|
| CR 12000 | CARES® s-ret bridge, TAV, 2 elements | |
| CR 12001 | CARES® s-ret bridge, TAV, 3 elements | |
| CR 12002 | CARES® s-ret bridge, TAV, 4 elements | |
| CR 12003 | CARES® s-ret bridge, TAV, 5 elements | |
| CR 12004 | CARES® s-ret bridge, TAV, 6 elements | |
| CR 12005 | CARES® s-ret bridge, TAV, 7 elements | |
| CR 12006 | CARES® s-ret bridge, TAV, 8 elements | |
| CR 12007 | CARES® s-ret bridge, TAV, 9 elements | BRIDGE |
| CR 12008 | CARES® s-ret bridge, TAV, 10 elements | |
| CR 12009 | CARES® s-ret bridge, TAV, 11 elements | |
| CR 12010 | CARES® s-ret bridge, TAV, 12 elements | |
| CR 12011 | CARES® s-ret bridge, TAV, 13 elements | |
| CR 12012 | CARES® s-ret bridge, TAV, 14 elements | |
| CR 12013 | CARES® s-ret bridge, TAV, 15 elements | |
| CR 12014 | CARES® s-ret bridge, TAV, 16 elements | |
| CR 12015 | CARES® Basic Bar, TAV, 2 Impl. | |
| CR 12016 | CARES® Basic Bar, TAV, 3 Impl. | |
| CR 12017 | CARES® Basic Bar, TAV, 4 Impl. | |
| CR 12018 | CARES® Basic Bar, TAV, 5 Impl. | |
| CR 12019 | CARES® Basic Bar, TAV, 6 Impl. | BASIC BAR |
| CR 12020 | CARES® Basic Bar, TAV, 7 Impl. | |
| CR 12021 | CARES® Basic Bar, TAV, 8 Impl. | |
| CR 12022 | CARES® Basic Bar, TAV, 9 Impl. | |
| CR 12023 | CARES® Basic Bar, TAV, 10 Impl. | |
| CR 12024 | CARES® Advanced Bar, TAV, 2 Impl. | |
| CR 12025 | CARES® Advanced Bar, TAV, 3 Impl. | |
| CR 12026 | CARES® Advanced Bar, TAV, 4 Impl. | |
| CR 12027 | CARES® Advanced Bar, TAV, 5 Impl. | |
| CR 12028 | CARES® Advanced Bar, TAV, 6 Impl. | ADVANCED BAR |
| CR 12029 | CARES® Advanced Bar, TAV, 7 Impl. | |
| CR 12030 | CARES® Advanced Bar, TAV, 8 Impl. | |
| CR 12031 | CARES® Advanced Bar, TAV, 9 Impl. | |
| CR 12032 | CARES® Advanced Bar, TAV, 10 Impl. | |
| CR 12033 | CARES® Complex Bar, TAV, 2 Impl. | |
| CR 12034 | CARES® Complex Bar, TAV, 3 Impl. | |
| CR 12035 | CARES® Complex Bar, TAV, 4 Impl. | |
| CR 12036 | CARES® Complex Bar, TAV, 5 Impl. | |
| CR 12037 | CARES® Complex Bar, TAV, 6 Impl. | COMPLEX BAR |
| CR 12038 | CARES® Complex Bar, TAV, 7 Impl. | |
| CR 12039 | CARES® Complex Bar, TAV, 8 Impl. | |
| CR 12040 | CARES® Complex Bar, TAV, 9 Impl. | |
| CR 12041 | CARES® Complex Bar, TAV, 10 Impl. |
Table 1 – Listing of devices
6
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
Intended Use 5.5
CARES® Screw-retained Bars and Bridges are prosthetic components directly connected to the endosseous dental implant as an aid in prosthetic rehabilitations.
Indications for Use 5.6
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. CARES® Screwretained Bridges and Bars are indicated for screw-retained restorations.
CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant systems (Implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)):
Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0 Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4
Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0)
Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0
Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0, 5.0 / Platform 3.4, 4.1, 5.0
Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0
Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1
Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7
Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0
Dentsply Implants – XiVE S / T- Series / Diameter 3.4. 3.8. 4.5. 5.5 / Platform 3.4. 3.8. 4.5. 5.5
5.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 2. The Indications for Use Statement for the subject devices has been modified from the primary predicate (K190097) to include the implant-to-abutment compatibilities.
7
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
The implant-to-abutment compatibilities (E-, EV-, F-, H-, I-, K-, R-, S-, and T-Series) are identical to the reference device, excluding the 3.0 mm implant diameter/3.0 mm platform diameter DENTSPLY Implants EV Series (K120414). Reverse Engineering Analysis for the addition of this new compatibility was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. Reverse engineering was not needed for the addition of the implant-to-abutment compatibilities for the GM-Series, because the implant-to-abutment connection dimensions were shared as part of a business partnership with the OEM company. The device materials of the subject device are identical to the reference device K170838. Please note that the MRI compatibility reference device K180564 – MRI Safety Information Labeling Change is included for the MRI only. K150203 is included for reference to dynamic fatigue testing (this is the primary predicate to K170838).
The design step defined in the subject device allows to control the same design limits implemented in the primary predicate (K190097). The design of the CARES® Screw - Retained Bars and Bridges Framework is performed by a trained technician using a Commercial Off-The-Shelf (COTS) Software. The design parameters are identical between the subject devices and the primary predicate (K190097) and are respected during the design of the restoration. Once the design is finalized, the design file is digitally transferred to a Straumann milling center holding the appropriate Establishment Registration. The prosthetic restoration is then manufactured according 21 CFR 820 Quality System Regulations. After production, all CARES® Screw - Retained Bars and Bridges undergoes a rigid Quality Control. If the result is correct, production sends the device to the customer. The manufacturing process for the subject devices is identical to the primary predicate (K190097).
8
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Feature | CARES® Screw - Retained Bars and Bridges | K190097 - Straumann CARES® Screw-Retained | |
| Bridges and Bars | K170838 - Medentika CAD/CAM TiBases | ||
| Indications for use | 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. | |||
| CARES® Screw-retained Bridges and Bars are | |||
| indicated for screw-retained restorations. | |||
| CARES® Screw - Retained Bars and Bridges are | |||
| designed to interface with the following dental | |||
| implant systems (Implant System Compatibility / | |||
| Series / Implant diameter (mm) / Platform | |||
| diameter (mm)): | |||
| Nobel Biocare Replace Select / E-Series / | |||
| Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, | |||
| 5.0, 6.0 | |||
| Dentsply Implants - ASTRA TECH OsseoSpeed | |||
| EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform | |||
| 3.0, 3.6, 4.2, 4.8, 5.4 | |||
| Nobel Biocare NobelActive / F-Series / Diameter | |||
| 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 | |||
| (5.0) | |||
| Neodent - Grand Morse / GM Series / Diameters | |||
| 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0 | |||
| Biomet 3i - Certain / H-Series / Diameter 3.25, | |||
| 4.0, 5.0 / Platform 3.4, 4.1, 5.0 | |||
| Biomet 3i - External Hex / I-Series / Diameter | |||
| 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0 | |||
| Nobel Biocare - Brånemark System / K-Series / | |||
| Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, | |||
| 4.1, 5.1 | |||
| Zimmer Dental Tapered Screw-vent / R-Series / | |||
| Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, | |||
| 5.7 | |||
| Dentsply Implants - ASTRA TECH OsseoSpeed | |||
| TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / | |||
| Platform 3.5, 4.0, 4.5, 5.0 | |||
| Dentsply Implants - XiVE S / T- Series / Diameter | |||
| 3.4, 3.8, 4.5, 5.5 / Platform 3.4, 3.8, 4.5, 5.5 | 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). | 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-Series / 3.5, | |||
| 4.3, 5.0, 6.0 / 3.5, 4.3, 5.0, 6.0 | |||
| Dentsply Implants/ASTRA TECH OsseoSpeed | |||
| EV/ EV-Series / 3.6, 4.2, 4.8, 5.4 / 3.6, 4.2, 4.8, | |||
| 5.4 | |||
| Nobel Biocare NobelActive™ / F-Series / 3.5, 4.3, | |||
| 5.0 / 3.5, 3.9 (4.3), 3.9 (5.0) | |||
| Biomet 3i Osseotite® Certain® / H-Series / 3.25, | |||
| 4.0, 5.0 / 3.4, 4.1, 5.0 | |||
| Biomet 3i Osseotite® / I-Series / 3.25, 3.75, 4.0, | |||
| 5.0 / 3.4, 4.1, 5.0 | |||
| Nobel Biocare Brånemark / K-Series / 3.3, 3.75, | |||
| 4.0, 5.0 / 3.5, 4.1, 4.1, 5.1 | |||
| Straumann Bone Level / L-Series / 3.3, 4.1, 4.8 / | |||
| 3.3, 4.1, 4.8 | |||
| Straumann Standard / N-Series / 3.3, 4.1, 4.8 / 3.5 | |||
| (NNC), 4.8, 6.5 | |||
| Zimmer Tapered Screw-Vent® / R-Series / 3.3, | |||
| 3.7, 4.1, 4.7, 6.0 / 3.5, 4.5, 5.7 | |||
| Astra Tech OsseoSpeed™ / S-Series / 3.5, 4.0, | |||
| 4.5, 5.0 / 3.5, 4.0, 4.5, 5.0 | |||
| Dentsply Friadent® Frialit/XiVE® / T-Series / 3.4, | |||
| 3.8, 4.5, 5.5 / 3.4, 3.8, 4.5, 5.5 | |||
| Dentsply Friadent® Ankylos® / Y-Series / 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 copings and/or crowns are intended to | |||
| be sent to Straumann for manufacture at a | |||
| validated milling center. | |||
| Feature | Subject Device | Predicate Device | Reference Device |
| CARES® Screw - Retained Bars and Bridges | K190097 - Straumann CARES® Screw-Retained | ||
| Bridges and Bars | K170838 – Medentika CAD/CAM TiBases | ||
| Material of the | |||
| restoration | Ti6Al4V, Titanium grade 5, conforming | ||
| ASTM F 136 | Restorations: | ||
| Cobalt Chromium Alloy (CoCr) | |||
| Titanium Grade 4 | Ti6Al4V, Titanium grade 5, conforming | ||
| ASTM F 136 | |||
| Material of screws | Ti6Al4V, Titanium grade 5, conforming | ||
| ASTM F 136 | Screws: | ||
| Titanium-Aluminum-Niobium alloy (Ti-6Al- | |||
| 7Nb) | Ti6Al4V, Titanium grade 5, conforming | ||
| ASTM F 136 | |||
| Interface | Non engaging | Non engaging | Engaging |
| Restoration | |||
| Types Supported | Bridges from 2 units to 16 units (full-arch) | ||
| Bars from 2 units to 10 units | Bridges from 2 units to 16 units (full-arch) | ||
| Bars from 2 units to 10 units | Single restorations | ||
| Design Workflow | CAD- Commercial Off-The-Shelf (COTS) | ||
| Software | CAD - CARES Visual Software | Straumann CARES System | |
| Manufacturing | |||
| Workflow | Straumann Milling Center | Straumann Milling Center | Straumann Milling Center |
| Design Software | Manual design by a trained dental technician | ||
| under the Straumann Quality System using | |||
| Commercial Off-The-Shelf (COTS) Software | |||
| and based on defined design limit by work | |||
| instruction and training | Straumann CARES Visual Software | Straumann CARES Visual Software | |
| Design Limits for | |||
| Patient Specific | |||
| Component | Critical geometry parameters are controlled | ||
| during CAD design step based on defined | |||
| design limit by work instruction and training. | |||
| After manufacturing the devices undergo | |||
| rigid quality controls. | Critical geometry parameters are enforced | ||
| by CARES Visual Software limits | Critical geometry parameters are enforced | ||
| by CARES Visual Software limits | |||
| Sterility | Delivered non-sterile | Delivered non-sterile | Delivered non-sterile |
| Sterilization by | |||
| end user | Yes | Yes | Yes |
| Method of | |||
| sterilization | Moist heat (steam autoclave) | Moist heat (steam autoclave) | Moist heat (steam autoclave) |
| Feature | Subject Device | Predicate Device | Reference Device |
| CARES® Screw - Retained Bars and Bridges | K190097 - Straumann CARES® Screw-Retained | ||
| Bridges and Bars | K170838 – Medentika CAD/CAM TiBases | ||
| Mode of Action | Screw-retained | Screw-retained | Screw-retained |
| Reusable | No | No | No |
| Packaging | Box package for the milled restoration and | ||
| the screws | Box package for the restoration and the | ||
| screws | The abutment in reclosable poly bag and the | ||
| corresponding screws are individually | |||
| packed in a plastic bag, co-packaged in a | |||
| craft board box |
9
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
10
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
Table 2 – Technological Characteristics
11
CARES® Screw - Retained Bars and Bridges (SRBB)
510(k) Summary
Performance Testing 5.8
The implant to abutment connections for the E-, EV-, F-, H-, I-, K-, R-, S-, and T-Series are identical to the implant to abutment compatibilities of the reference devices (K170838), except for the addition of the 3.0 mm implant diameter/3.0 mm platform diameter DENTSPLY Implants EV Series (K120414), for which Reverse Engineering Analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. For the addition of the new line of abutments (GM-Series), the implant to abutment connection were shared as part of a business partnership.
The change in design workflow from the CARES Visual Software to COTS software does not require additional testing to support substantial equivalence as the design parameters are identical between the subject devices and the primary predicate (K190097) and are respected during the design of the restoration by a trained dental technician under the Straumann Quality System to ensure the pre-defined design limits have been followed.
Dynamic fatigue testing was 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" and demonstrated that the CARES® Screw - Retained Bars and Bridges are equivalent to the predicate and reference devices.
The subject device materials and manufacturing process are identical to the primary predicate (K190097) and reference (K170838) devices, therefore, no new issues regarding biocompatibility were raised.
The sterilization process for the CARES® Screw - Retained Bars and Bridges, as recommended in the labeling, was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015", and conforming to the ISO 17665-1 and ISO/TS 17665-2.
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates the CARES® Screw -Retained Bars and Bridges are substantially equivalent to the primary predicate and reference devices.