(92 days)
The Straumann NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.
The Straumann NC Temporary Abutments are indicated for use in Straumann NC 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 abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
This is a medical device application for the Straumann NC Temporary Abutments. This submission focuses on establishing substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance evaluation against those criteria. Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
Here's why and what the text does provide:
- 510(k) Submissions: These submissions primarily aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. It typically does not involve setting specific performance acceptance criteria for the new device as would be seen in a clinical trial designed to prove effectiveness or safety against predefined benchmarks.
The document states:
- "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."
Therefore, I cannot populate the table or answer the specific questions you posed because the provided text does not contain the type of study data and acceptance criteria you are looking for. The focus of this document is on regulatory equivalence, not on a detailed performance study against a set of predefined acceptance criteria for a new device.
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14092814
Section I 510(k) Summary DEC 1 5 2009
1. 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 11, 2009
2. Name of the Device
Trade Name: Common Name: Classification Name: Regulation Number:
Straumann NC Temporary Abutments Abutment, Dental, Endosseous implants Abutment, Dental, Endosseous implants 8872.3630
-
- Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
NC Temporary Abutments, K072679
- 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 abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
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5. Intended Use of the Device
The NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Elaine Alan Regulatory Affairs Specialist Straumann Manufacturing, Incorporated 60 Minuteman Road Andover, Massachusetts 01810
DEC 1 5 2009
Re: K092814
Trade/Device Name: Straumann NC Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2009 Received: December 4, 2009
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.
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 (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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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
Enclosure
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Indications for Use Statement
Device Name: Straumann NC Temporary Abutments
Indications for Use:
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
X 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
TSBetz DDS for Dr. K.P. Mulvey (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Number: K092814
510(k) Submission: NC Temporary Abutments Proprietary and Confidential September 11, 2009
Straumann US -Page-5
§ 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.)