(143 days)
No
The description focuses on CAD/CAM design and manufacturing of dental prosthetics, with no mention of AI or ML for analysis, design, or other functions.
Yes
The device is indicated for restoring chewing function and providing support for prosthetic reconstructions, which are therapeutic purposes aimed at improving or restoring a patient's health or bodily function.
No
Explanation: The device is described as a prosthetic reconstruction (bars and bridges) for restoring chewing function, designed to attach to dental implants. It facilitates customization and is fabricated for individual patients. Its purpose is restoration, not diagnosis. The "scan of the patient model" mentioned as "Input Imaging Modality" is used for design and fabrication, not for diagnosing a condition.
No
The device description clearly states that the device is a physical product (bars and bridges) fabricated using CAD/CAM techniques, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic reconstructions (bridges and over-dentures) to restore chewing function. This is a mechanical and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical component (bars and bridges) designed to attach to dental implants. It is a patient-specific medical device fabricated for an individual patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is clearly a dental prosthetic component used for restoration and function, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants 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.
Product codes
NHA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician or dental technician
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)
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.
Conclusions: Based upon our assessment of the performance data, the subject devices have been determined to be safe and effective for their intended uses and are substantially equivalent to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K133421, K062129, K101465, K112280
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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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
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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, 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.