(134 days)
Not Found
No
The summary describes a system of dental implants and abutments, which are physical components. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The description focuses on the mechanical function of the abutments.
No
The device, an abutment, is used to support prosthetic reconstructions in dental implants, which is a structural and restorative function, not a therapeutic one. It does not treat or cure a disease.
No
The device described is an abutment for dental implants, used to support prosthetic reconstructions. It is a restorative component, not a diagnostic tool.
No
The device description explicitly states it 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." This clearly indicates the device includes physical hardware components (implants, abutments, instruments) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the abutments are placed into dental implants to provide support for prosthetic reconstructions. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces that the system is for supporting prosthetic devices in patients.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This dental abutment system does not fit that description.
N/A
Intended Use / Indications for Use
Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
Product codes
NHA
Device Description
The Straumann P.004 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, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are anatomic abutments.
Abutments are placed into dental implants to provide support for prosthetic restorations.
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)
P.004 RC Anatomic Abutments, K062129
Reference Device(s)
Not Found
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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SEP 2 6 2007
Section J 510(k) SUMMARY
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2507 Fax Number: 978-747-0023 Paige Sweeney Contact Person: Manager, Requlatory Affairs Date of Submission: May 11, 2007
2. Name of the Device
| Trade Name: | P.004 NC Anatomic Abutments |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | 21 CFR 872.3630 |
- e Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
P.004 RC Anatomic Abutments, K062129
4. Description of the Device
The Straumann P.004 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, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are anatomic abutments.
Abutments are placed into dental implants to provide support for prosthetic restorations.
5. Intended Use of the Device
Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
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6. Technological Characteristics
The modified Anatomic Abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed closure screws have the same material composition, basic design and fundamental operating principles to the currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Ms. Paige Sweeney Manager, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K071357
Trade/Device Name: P.004 NC Anatomic Abutments Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 2, 2007 Received: August 3, 2007
Dear Ms. Sweeney:
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.
SEP 2 6 2007
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.
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Page 2 - Ms. Sweeney
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 (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.
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 your 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.
Syndite y. Richards
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
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K071357
INDICATIONS FOR USE STATEMENT
Device Name: P.004 NC Anatomic Abutments
Indications for Use:
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
| Prescription Use | X |
|---|---|
| (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
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K071357 |
510(k) Submission: P.004 NC Anatomic Abutments May 11, 2007 Proprietary and Confidential .
Straumann US Page 5