Who is the manufacturer of CARES Screw - Retained Bars and Bridges (SRBB)?

Medentika GmbH filed the 510(k) submission for CARES Screw - Retained Bars and Bridges (SRBB) (K201711).

What is the FDA product code for CARES Screw - Retained Bars and Bridges (SRBB)?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for CARES Screw - Retained Bars and Bridges (SRBB)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CARES Screw - Retained Bars and Bridges (SRBB)?

Straumann CARES® Screw-Retained Bridges and Bars (K190097).

Who can help prepare an FDA 510(k) submission like CARES Screw - Retained Bars and Bridges (SRBB)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARES Screw - Retained Bars and Bridges (SRBB)

K201711 · Medentika GmbH · NHA · Dec 8, 2020 · Dental

Device Facts

Record ID	K201711
Device Name	CARES Screw - Retained Bars and Bridges (SRBB)
Applicant	Medentika GmbH
Product Code	NHA · Dental
Decision Date	Dec 8, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

CARES® Screw-retained Bars and Bridges are prosthetic components directly connected to the endosseous dental implant as an aid in prosthetic rehabilitations.

Device Story

Patient-specific dental prosthetic components (bars and bridges) designed to interface with various endosseous dental implants; fabricated via CAD/CAM workflow. Clinicians or dental technicians use COTS software to design restorations based on patient scans; design files transferred to milling center for production. Devices made of titanium Grade 5 (ASTM F136). Final products attached to implants via screws to support bridges or overdentures; intended to restore chewing function. Used in dental clinics/laboratories; non-sterile delivery; requires steam autoclave sterilization by end user.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed per FDA guidance for root-form endosseous dental implants and abutments. Biocompatibility supported by identical materials and manufacturing processes to predicate/reference devices. Sterilization validated per ISO 17665-1 and ISO/TS 17665-2.

Technological Characteristics

Material: Titanium Grade 5 (Ti6Al4V) per ASTM F136. Design: CAD/CAM, patient-specific. Connectivity: Digital file transfer to milling center. Sterilization: Moist heat (steam autoclave). Software: COTS-based design workflow with manual oversight by trained technicians following defined design limits.

Indications for Use

Indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. Final processed products restore chewing function. Indicated for screw-retained restorations. Compatible with specific dental implant systems (Nobel Biocare, Dentsply Implants, Neodent, Biomet 3i, Zimmer Dental).

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Straumann CARES® Screw-Retained Bridges and Bars (K190097)

Reference Devices

Medentika CAD/CAM TiBases (K170838)
Neodent GM (Grand Morse) implant Line (K180536)
OsseoSpeed™ Plus (K120414)
MRI Safety Information Labeling Change (K180564)
Medentika CAD/CAM Abutments (K150203)

Related Devices

K212676 — Osteon Precision Milled Suprastructure · Implant Solutions Pty Ltd (Osteon Medical) · Mar 3, 2022
K211396 — Neoss Individual Prosthetics · Neoss, Ltd. · May 17, 2022
K112280 — STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM · Straumann USA · Nov 16, 2011
K162633 — Custom Bars · Implant Direct Sybron Manufacturing, LLC · Jul 24, 2017
K253253 — IPDmilled Blanks · Implant Protesis Dental 2004, S.L. · Jan 22, 2026

Submission Summary (Full Text)

{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) K201711 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 This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: 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…