(105 days)
Not Found
No
The summary describes a physical dental implant component (temporary coping) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a temporary coping used as a base for temporary dental restorations and bridges, which are prosthetic devices, not therapeutic devices. Its function is to support other devices, not to treat or cure a disease or condition.
No
The device acts as a temporary base for restorations, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly states it is a "temporary coping," which is a physical component used in dental restorations, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Narrow Neck Temporary Coping is a dental device used as a base for temporary restorations on dental implants. It is a physical component used in a surgical and prosthetic procedure within the mouth.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status.
Therefore, the function and intended use of this device fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.
Product codes
NHA
Device Description
The Straumann 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, abutments and surgical and prosthetic parts and instruments. The device covered in this submission is a temporary coping.
The Straumann Narrow Neck Temporary Coping intended to serve as a base for temporary restorations. The temporary coping is for use on the Straumann Standard Plus Ø3.3mm Narrow Neck Implant.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.)
0
070744
SECTION I 510(k) Summary
JUN 2 9 2007
1. Applicant's Name and Address
Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810
Telephone Number: Fax Number: Contact Person:
Date of Submission:
978-747-2513 978-747-0023 Elaine Alan Regulatory Affairs Specialist March 15, 2007
2. Name of the Device
Trade Name: Common Name: Classification Name: Narrow Neck Temporary Coping Accessory to Endosseous Dental Implant Accessory to Endosseous Dental Implant 21 CFR 872.3640
4. Description of the Device
The Straumann 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, abutments and surgical and prosthetic parts and instruments. The device covered in this submission is a temporary coping.
The Straumann Narrow Neck Temporary Coping intended to serve as a base for temporary restorations. The temporary coping is for use on the Straumann Standard Plus Ø3.3mm Narrow Neck Implant.
5. Intended Use of the Device
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use up to six months.
1
റ. Basis for Substantial Equivalence
The proposed coping is substantially equivalent to the previously cleared Titanium Coping for Anterior Implant, K032498, and the RN SynOcta® Temporary Meso Abutment, K051717. The proposed device is substantially equivalent in intended use, operating principle and basic design and is made of the same materials as the currently marketed devices.
:
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a flowing, abstract design.
JUN 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institute Straumann AG C/O Ms. Elaine Alan Straumann USA Regulatory Affairs Specialist 60 Minuteman Road Andover, Massachusetts 01810
Re: K070744
Trade/Device Name: Narrow Neck Temporary Coping Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 7, 2007 Received: June 8, 2007
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 such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Runner
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K ♡フロ フィイ
Narrow Neck Temporary Coping Device Name:
Indications for Use:
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants Ø3.3mm Narrow Neck for use 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)
Suser Ruape
ision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number: K070744
Narrow Neck Temporary Coping March 15, 2007
Propriety and Confidential
Straumann USA Page 5 of 27