(16 days)
No
The summary describes a system of dental implants, abutments, and related components, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML mentions.
No
The device provides structural support for prosthetic restorations and protects the abutment during healing, but it does not directly treat or prevent a disease or condition.
No
The device components described (abutments, protective caps, temporary copings) are all designed to provide physical support or protection for dental prosthetics in patients with dental implants. There is no mention of these devices being used to diagnose a condition, gather data for diagnosis, or perform any form of assessment.
No
The device description clearly states it is an integrated system of endosseous dental implants, abutments, and surgical/prosthetic parts and instruments, which are physical hardware components.
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 describes the device as being placed into dental implants to support prosthetic reconstructions and protect/condition soft tissue. This is a direct interaction with the patient's body for structural support and healing, not for testing or analyzing samples from the body.
- Device Description: The description reinforces that the system consists of implants, abutments, and surgical/prosthetic parts used to support prosthetic devices in patients.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment.
Therefore, the Straumann P.004 Dental Implant System, as described, falls under the category of a medical device used for surgical and prosthetic purposes, not an in vitro diagnostic device.
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 and overdentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
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 surqical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
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.)
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Section H 510(k) SUMMARY AUG 15 2007
1. Applicant's Name and Address
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 978-747-2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: July 27. 2007
2. Name of the Device
| Trade Name: | P.004 RC Cementable Abutments |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| Regulation Number: | 21 CFR 872.3630 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
P.004 RC Anatomic Abutments, K062129 Temporary Copings, K041070 ITI Protective Healing Caps, K962023
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 surqical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
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. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days. Protective Caps are intended to protect the outer configuration of the abutment and to maintain and
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K072071
condition the contours of the soft tissue during the healing phase for up to 6 months.
ર. Technological Characteristics
The modified Anatomic Abutments, Temporary Copings and Protective Caps are substantially equivalent to the currently cleared devices. The intended use is identical to the predicate devices. The proposed devices have the same material composition, basic design and fundamental operating principles to the currently cleared devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing service and protection. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K072071
Trade/Device Name: P.004 Cementable Abutments, Temporary Copings and Protective Caps Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 27, 2007 Received: July 30, 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.
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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); 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 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,
Chris Liu, Ph.D.
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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INDICATIONS FOR USE STATEMENT
Device Name: P.004 Cementable 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.
Device Name: P.004 Protective Caps
Indications for Use:
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Device Name: P.004 Temporary Copings
Indications for Use:
Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
× 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)
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Susan Evans
vision of Anesthesiology, General Hospital, Intection Control, Dental Devices
| 510(k) Submission: RC Cementable Abutments | |
|---|---|
| 510(k) Number: | K1207 |
| July 27, 2007 | |
| Straumann US | |
| Page 5 |
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