(143 days)
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.
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 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.
This document describes the Straumann® CARES® Screw-Retained Bridges and Bars. The information provided is from a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from predicate device/guidance) | Reported Device Performance (for Straumann® CARES® Screw-Retained Bridges and Bars) |
|---|---|---|
| Dynamic Fatigue Strength (ISO 14801 and modified) | Not explicitly stated in the document | "Dynamic fatigue test data consistent with FDA guidance, ISO 14801 and a modified ISO 14801 protocol have been referenced in support of this submission." (Implies meeting or exceeding predicate performance/guidance) |
| Materials (Cobalt Chromium, Commercially Pure Titanium Grade 4, Ti-6Al-7Nb) | Compliance with international standards for dental applications | "All of these materials comply with international standards applicable to materials for dental applications." |
| Design, Operating Principles, Manufacturing Methods, Sterilization | Identical to previously cleared SRBB constructs | "the materials, design, fundamental operating principles, manufacturing methods and sterilization method are identical to those of the previously cleared SRBB constructs" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "bench studies" and "dynamic fatigue test data," which typically involve a set number of samples for mechanical testing, but the exact quantity is not specified.
- Data Provenance: The document does not specify country of origin for the data. The data is retrospective in the sense that it relies on established standards (ISO 14801) and comparisons to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable for this type of submission. The ground truth for this device is established through engineering and material science principles, compliance with ISO standards, and comparison to a predicate device's established safety and effectiveness through bench testing. Clinical expert consensus for "ground truth" (as in diagnostic accuracy studies) is not relevant here.
4. Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is established through engineering and material standards, adjudication by human experts is not part of the evaluation process for this specific device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical dental prosthetic device, not a diagnostic AI algorithm. Therefore, such a study was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This device is a physical dental prosthetic, not a software algorithm or AI.
7. The Type of Ground Truth Used:
- For physical properties and performance (e.g., fatigue strength, material biocompatibility), the ground truth is established by engineering standards (e.g., ISO 14801), material specifications, and regulatory guidance documents. The device's performance is compared against the known performance and characteristics of the predicate device (K132844) to establish substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This submission focuses on a physical medical device, not a machine learning model that requires a training set. The "design" of the device is developed by engineers and clinicians using CAD software, not "trained" on data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8. The "design" is based on anatomical considerations, biomechanical principles, and the functional requirements for dental restorations, as implemented through CAD software. There isn't a "ground truth" for a training set in the context of an AI algorithm here.
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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.
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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
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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)
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5. 510(k) Summary
| Submission Number: | K140737 |
|---|---|
| Submitter: | Straumann USA, LLC60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052 |
| Contact Person: | Christopher KlaczykDirector 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 BarsStraumann® 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 StraumannCARES Screw-Retained Bridges are used for the restoration ofStraumann dental implants with different endosteal diameters,lengths and platforms and Straumann Screw-RetainedAbutments. The bars and bridges presented in the premarketnotification submission (identified as “SRBB" for ScrewRetained Bars and Bridges) are designed to interface withpreviously cleared screw-retained abutments (K133421). Wealso present "multi-level" bars and bridges in this submissiondesigned to interface with any combination of screw-retainedabutments (as cleared per premarket notification K133421),Bone Level (BL) implants (as cleared per premarketnotification K062129) and Tissue Level (TL) implants (ascleared per premarket notifications K101465 and K112280) of |
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| the SDIS. When SRBB devices are attached directly to dentalimplants of the SDIS; the abutment/secondary part is an integralpart of the SRBB device. | |
|---|---|
| SRBB devices facilitate customization to meet the functionaland esthetic requirements of the individual patient. They arepatient-specific medical devices, i.e. they are designed by theclinician or dental technician and fabricated by Straumannspecifically for an individual patient. | |
| SRBB devices are designed via Straumann approved ComputerAided Design (CAD) software such as Straumann® CARES®Visual. After importing a scan of the patient model, the CADsoftware is used to generate digital restoration modelsincorporating the subject devices. The digital restoration modelis transferred to the milling center where the restoration isproduced using Computer Aided Manufacturing (CAM)-techniques. | |
| Intended Use: | Straumann CARES Screw-Retained Bridges and Bars areindicated for use as bars and bridges that attach to implants andto screw-retained abutments of the Straumann Dental ImplantSystem (SDIS) to provide support for prosthetic reconstructionssuch as bridges and over-dentures. The final processed productshave the purpose of restoring chewing function. |
| Straumann CARES Screw-Retained Bridges and Bars areindicated for screw-retained restorations. | |
| Materials: | Milling blanks for the fabrication of the subject devices areavailable in two different materials, a cobalt chromium alloyand commercially pure titanium of grade 4. The basal andocclusal screws are fabricated from a titanium-aluminum-niobium alloy, Ti-6Al-7Nb, also referred to as TAN. All ofthese materials comply with international standards applicableto materials for dental applications. |
| TechnologicalCharacteristics: | Aside from incorporating features to facilitate connection toStraumann Screw Retained Abutments, the materials, design,fundamental operating principles, manufacturing methods andsterilization method are identical to those of the previouslycleared SRBB constructs intended for use with Straumann BoneLevel and Tissue Level implants. |
| No new surgical instruments or secondary components arebeing introduced as a result of this submission. |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II SpecialControls Guidance Document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments dated May 12,2004, the substantial equivalence of the subject device(s) aresatisfactorily addressed via bench studies. Dynamic fatigue testdata consistent with FDA guidance, ISO 14801 and a modifiedISO 14801 protocol have been referenced in support of thissubmission. |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- 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.
§ 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.)