Who is the manufacturer of STRAUMANN CARES SCREW RETAINED BARS/BRIDGE?

Straumann USA, LLC filed the 510(k) submission for STRAUMANN CARES SCREW RETAINED BARS/BRIDGE (K140737).

What is the FDA product code for STRAUMANN CARES SCREW RETAINED BARS/BRIDGE?

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

What is the regulatory pathway for STRAUMANN CARES SCREW RETAINED BARS/BRIDGE?

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

Who can help prepare an FDA 510(k) submission like STRAUMANN CARES SCREW RETAINED BARS/BRIDGE?

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.

STRAUMANN CARES SCREW RETAINED BARS/BRIDGE

Q: What are the predicate devices for STRAUMANN CARES SCREW RETAINED BARS/BRIDGE?

Straumann® CARES® Screw-Retained Bridges and Bars (K132844); Straumann® Magellan Screw-Retained Abutments (K133421).

K140737 · Straumann USA, LLC · NHA · Aug 14, 2014 · Dental

Device Facts

Record ID	K140737
Device Name	STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
Applicant	Straumann USA, LLC
Product Code	NHA · Dental
Decision Date	Aug 14, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/or to screw-retained abutments 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.

Device Story

Patient-specific dental prosthetic components (bars/bridges) for Straumann Dental Implant System; designed via CAD software (Straumann CARES Visual) using patient model scans; fabricated via CAM milling; interfaces with implants or screw-retained abutments; used by clinicians/dental technicians to restore chewing function; provides support for bridges/over-dentures.

Clinical Evidence

Bench testing only. Dynamic fatigue testing performed consistent with ISO 14801 and modified ISO 14801 protocols to demonstrate safety and effectiveness.

Technological Characteristics

Materials: Cobalt chromium alloy, commercially pure titanium (Grade 4), and Ti-6Al-7Nb (TAN) alloy. CAD/CAM fabrication. Interfaces with Straumann Dental Implant System. Sterilization: Not specified (standard dental practice).

Indications for Use

Indicated for patients requiring prosthetic reconstruction (bridges/over-dentures) supported by Straumann Dental Implant System implants or screw-retained abutments to restore chewing function.

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 (K132844)
Straumann® Magellan Screw-Retained Abutments (K133421)

Reference Devices

Bone Level (BL) implants (K062129)
Tissue Level (TL) implants (K101465)
Tissue Level (TL) implants (K112280)

Related Devices

K160207 — ATLANTIS ISUS Implant Suprastructures · Dentsply International, Inc. · Sep 21, 2016
K201711 — CARES Screw - Retained Bars and Bridges (SRBB) · Medentika GmbH · Dec 8, 2020
K101465 — STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR · Institut Straumann AG · Dec 13, 2010
K112280 — STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM · Straumann USA · Nov 16, 2011
K190097 — Straumann CARES Screw-Retained Bridges and Bars · Institut Straumann AG · Jun 26, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 14, 2014 Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, MA 01810 Re: K140737 Trade/Device Name: Strauman® CARES® Screw-Retained Bridges and Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: July 17, 2014 Received: July 18, 2014 Dear Mr. Klaczyk: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Klaczyk 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mary S. Runner -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 4. Indications For Use 510(k) Number (if known): K140737 Straumann® CARES® Screw-Retained Bridges and Bars Device Name: Indications for Use: Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/or to screw-retained abutments 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ## 5. 510(k) Summary | Submission Number: | K140737 | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | | Contact Person: | Christopher Klaczyk Director of Regulatory Affairs and Clinical Research (978) 747-2575 | | Date Prepared: | March 21, 2014 | | Product Code(s): | NHA (21 CFR 872.3630) | | Device Class: | II (21 CFR 872.3630) | | Classification Panel: | Dental | | Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | | Proprietary Name: | Straumann® CARES® Screw-Retained Bars Straumann® CARES® Screw-Retained Bridges | | Predicate Device(s): | Straumann® CARES® Screw-Retained Bridges and Bars (K132844) Straumann® Magellan Screw-Retained Abutments (K133421) | | Device Description: | The Straumann CARES Screw-Retained Bars and Straumann CARES Screw-Retained Bridges are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms and Straumann Screw-Retained Abutments. The bars and bridges presented in the premarket notification submission (identified as “SRBB" for Screw Retained Bars and Bridges) are designed to interface with previously cleared screw-retained abutments (K133421). We also present "multi-level" bars and bridges in this submission designed to interface with any combination of screw-retained abutments (as cleared per premarket notification K133421), Bone Level (BL) implants (as cleared per premarket notification K062129) and Tissue Level (TL) implants (as cleared per premarket notifications K101465 and K112280) of | {4}------------------------------------------------ | | the SDIS. When SRBB devices are attached directly to dental implants of the SDIS; the abutment/secondary part is an integral part of the SRBB device. | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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 the clinician or dental technician and fabricated by Straumann specifically for an individual patient. | | | SRBB devices are designed via Straumann approved Computer Aided Design (CAD) software such as Straumann® CARES® Visual. After importing a scan of the patient model, the CAD software is used 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. | | Intended Use: | Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and to screw-retained abutments 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. | | Materials: | Milling blanks for the fabrication of the subject devices are available in two different materials, a cobalt chromium alloy and commercially pure titanium of grade 4. The basal and occlusal screws are fabricated from a titanium-aluminum- niobium alloy, Ti-6Al-7Nb, also referred to as TAN. All of these materials comply with international standards applicable to materials for dental applications. | | Technological Characteristics: | Aside from incorporating features to facilitate connection to Straumann Screw Retained Abutments, the materials, design, fundamental operating principles, manufacturing methods and sterilization method are identical to those of the previously cleared SRBB constructs intended for use with Straumann Bone Level and Tissue Level implants. | | | No new surgical instruments or secondary components are being introduced as a result of this submission. | {5}------------------------------------------------ | 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. Dynamic fatigue test data consistent with FDA guidance, ISO 14801 and a modified ISO 14801 protocol have been referenced in support of this submission. | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| - Based upon our assessment of the performance data, the subject Conclusions: devices have been determined to be safe and effective for their intended uses and are substantially equivalent to the identified predicate devices.