(76 days)
No
The 510(k) summary describes a system of dental implants and abutments, which are mechanical components. There is no mention of software, algorithms, image processing, AI, DNN, or ML.
No
The device, a dental implant system and its components (abutments), provides support for prosthetic reconstructions. It does not directly treat or prevent a disease or condition, which is a characteristic of a therapeutic device.
No
The device is a dental implant system and associated components designed to support prosthetic reconstructions. It does not gather or analyze data to diagnose a condition.
No
The device description clearly states it is an integrated system of endosseous dental implants, abutments, and surgical/prosthetic parts and instruments, indicating it includes hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are "intended to be placed into dental implants to provide support for prosthetic reconstructions". This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description confirms it's part of a "dental implant system" used to support "prosthetic devices for partially or fully edentulous patients". This further reinforces its use within the body for restorative purposes.
- Lack of IVD Characteristics: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, based on the provided information, this device is a medical device used for dental restoration, not an IVD.
N/A
Intended Use / Indications for Use
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
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.
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)
Straumann P.004 Dental Implants, K062129
Reference Device(s)
RN synOcta® Gold Coping, K990342, RN synOcta® Titanium Coping, K990342, Abutment for Bars, K894844
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.)
0
222 % 2007
Section I 510(k) Summary
Applicant's Name and Address 1.
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2507 Fax Number: 978-747-0023 Contact Person: Paige Sweeney Manager, Regulatory Affairs Date of Submission: July 11, 2007
2. Name of the Device
| Trade Name: | P.004 RC/NC Gold Abutment for Bars
P.004 RC/NC Titanium Abutment for Bars |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | §872.3630 |
es Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Straumann P.004 Dental Implants, K062129 RN synOcta® Gold Coping, K990342 RN synOcta® Titanium Coping, K990342 RN Abutment for Bars, K894844
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.
1
5. Intended Use of the Device
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Technological Characteristics 6.
The proposed 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of an eagle or bird-like figure with its wings spread, suggesting protection and care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2007
Ms. Paige Sweeney Manager, Regulatory Affairs Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K071919
Trade/Device Name: P.004 RC/NC Gold and Titanium Abutment for Bars Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 11, 2007 Received: July 12, 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.
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. 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 (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 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.
Smute y. Mchael Oms.
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 Statement
P.004 RC/NC Gold and Titanium Abutment for Bars Device Name:
Indications for Use:
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
× Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 1 of 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off |
|---|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |
| 510(k) Number: | K071919 |
|---|---|
| ---------------- | --------- |
510(k) Submission: P.004 RC/NC Gold and Titanium Abutments for Bars July 11, 2007 Proprietary and Confidential