(136 days)
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments. Abutments are placed on dental implants to provide support for dental restorations. Temporary abulments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
This looks like a 510(k) summary for a dental device, specifically "Straumann RC Temporary Abutments." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed studies of performance against specific acceptance criteria for a novel AI/software medical device.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment is not present in the provided text.
The document primarily focuses on:
- Identification of the device: Straumann RC Temporary Abutments.
- Identification of a predicate device: RC Temporary Abutments, K070478.
- Intended Use: For temporary restorations of single crowns and bridges for up to six months with Straumann RC Bone Level Dental Implants.
- Technological Characteristics: Stating that the proposed abutments are substantially equivalent to marketed devices, with identical intended use, material composition, basic design, and fundamental operating principles.
- FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence to a predicate device based on identical intended use, material, design, and operating principles, rather than reporting specific performance metrics against pre-defined acceptance criteria.
- Sample sized used for the test set and the data provenance: Not available. No specific test set or study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. This type of information is not relevant for a 510(k) summary of a physical dental abutment.
- Adjudication method: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical dental abutment, not an AI or software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Section I 510(k) Summary
| Applicant's Name and Address | Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 |
|---|---|
| Telephone Number: | 800-448-8168, ext 2513 |
| Fax Number: | 978-747-0023 |
| Contact Person: | Elaine Alan |
| Regulatory Affairs Specialist | |
| Date of Submission: | September 28, 2009 |
- Name of the Device
FEB 1 2 2010
Trade Name: Straumann RC Temporary Abutments Common Name: Abutment, Dental, Endosseous implants Classification Name: Abutment, Dental, Endosseous implants Regulation Number: $872.3630
-
- Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
RC Temporary Abutments, K070478
- Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
4. Description of the Device
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.
Abutments are placed on dental implants to provide support for dental restorations. Temporary abulments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
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y2
Image /page/1/Picture/1 description: The image shows a handwritten alphanumeric string, "K093027". The text is written in black ink on a white background. A horizontal line is drawn underneath the string, possibly indicating an underline or emphasis.
5. Intended Use of the Device
The RC Temporary Abutments are intended for use in Straumann RC Bone Level Dental Implant for temporary restorations of single crowns and bridges for up to six months.
6. Technological Characteristics
The proposed temporary abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices.
Request for Additional Information: K093027 RC Temporary Abutments January 5, 2009 Straumann US Page 2of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three curved lines that resemble a human figure or a stylized representation of a bird in flight. The overall design is simple and recognizable, representing the department's role in health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2010
Ms. Elaine Alan Regulatory Affairs Specialist Institut Straumann AG Straumann USA 60 Minuteman Road Andover. Massachusetts 01810
Re: K093027
Trade/Device Name: Straumann RC Temporary Abutments Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 20, 2010 Received: January 21, 2010
Dear Ms. Alan:
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- Ms. Alan
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/SafetyReportaProblem/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.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
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Indications for Use Statement
Device Name: Straumann RC Temporary Abutments
Indications for Use:
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Kain Huley for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.