(98 days)
No
The device description and intended use are purely mechanical components (dental implants and abutments) with no mention of software, data processing, or any terms related to AI/ML.
No.
The device (abutments) is intended to support prosthetic reconstructions in dental implants, not to treat a disease or restore health.
No
The device described, an abutment for dental implants, is a prosthetic component used to support dental reconstructions. It does not perform any diagnostic function such as identifying, monitoring, or predicting diseases or health conditions.
No
The device description clearly states it is an integrated system of physical dental implants, abutments, and surgical/prosthetic parts and instruments. The submission specifically covers abutments, which are physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are placed into dental implants to support prosthetic reconstructions. This is a surgical/dental procedure performed directly on a patient.
- Device Description: The description details the physical components of a dental implant system and how the abutments function within that system. It describes a physical device used in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as part of a dental restoration.
N/A
Intended Use / Indications for Use
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or 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. The devices covered in this submission are abutments.
Abutments can have an engaging or non-engaging connection to the implant. The basal portion of the engaging abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. Non-engaging abutments do not lock into the implant via the protrusion/groove connection. Both abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental implants
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.)
0
K071888
1082
Section I 510(k) SUMMARY
0CT 1 5 2007
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: July 6, 2007
2. Name of the Device
| Trade Name: | P.004 RC Gold Abutment for Bridge |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| 21 CFR 872.3630 |
Legally Marketed Device to which Equivalence is Claimed (Predicate 3. Device)
Straumann P.004 Dental Implants, K062129 synOcta® Gold Abutment, K041295
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 abutments.
Abutments can have an engaging or non-engaging connection to the implant. The basal portion of the engaging abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. Non-engaging abutments do not lock into the implant via the protrusion/groove connection. Both abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.
5. Intended Use of the Device
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.
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Image /page/1/Picture/0 description: The image shows handwritten text, with the characters "KC 71888" prominently displayed at the top. A horizontal line underlines this sequence. Below the line, the text "2 of 2" is written in a cursive style. The writing appears to be done with a pen or marker, and the overall impression is that of a label or identifier.
6. Technological Characteristics
The proposed abutment is substantially equivalent to the currently marketed devices. The intended use is substantially equivalent 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 & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
OCT 1 5 2007
Re: K071888 Trade/Device Name: P.004 Abutment
Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 3, 2007 Received: October 4, 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 (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,
Sunile y. Mchais Ous.
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
Device Name: P.004 Abutment
Indications for Use:
Abutments 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)
Concurrence of GDRH, Office of Device Evaluation (ODE)
Sun Prime
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K071888 |
|---|---|
| ---------------- | --------- |
510(k) Submission: P.004 Gold Abutments July 6, 2007
Proprietary and Confidential
Straumann US Page 5