(212 days)
Not Found
No
The document describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a temporary abutment used for dental implants for restoration and protection purposes, which falls under restorative or protective functions rather than therapeutic intervention to treat a disease or disorder.
No
The provided text describes the device as temporary abutments and healing abutments used for restoration, protection, and shaping of soft tissue after dental implant surgery. Its intended uses are purely therapeutic and supportive, not for diagnosis.
No
The device description clearly states it is a system of physical components including implants, abutments, and surgical/prosthetic parts and instruments. The submission specifically covers temporary abutments, which are physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the device is a dental implant system component (temporary abutments and healing abutments) used to support prosthetic devices in the mouth.
- Intended Use: The intended use is for temporary restoration of single crowns and bridges and protecting the inner configuration of the implant during healing. These are mechanical and structural functions within the body, not diagnostic tests performed on specimens outside the body.
The device is a medical device, specifically a dental device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.
Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase.
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
Product codes
NHA
Device Description
The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level 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 temporary abutments.
The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The 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. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anterior and posterior region
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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
SEP 2 0 2007
Section K 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: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: February 9, 2007
2. Name of the Devices
| Trade Name: | RC Temporary Abutments |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| 21 CFR 872.3640 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
Straumann P.004 Dental Implants, K062129 synOcta® Temporary Meso Abutment, K051717 P.004 RC Meso Abutment, K062129
4. Description of the Device
The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level 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 temporary abutments.
The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The 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. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.
5. Intended Use of the Device
1
The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.
Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase.
6. Technological Characteristics
The proposed abutments are substantially equivalent to the currently marketed devices. The intended use and materials are identical to the predicate devices. The proposed abutments have the same 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 eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elaine Alan Regulatory Affairs Specialist Straumann Manufacturing, Incorporated 60 Minuteman Road Andover, Massachusetts 01810
SEP 2 0 2007
Re: K070478 Trade/Device Name: P.004 RC Temporary Abutment, P.004 Healing Abutment, customizable (cap) Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 21, 2007 Received: August 22, 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 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.
Sougie J.M. Michaux Davis
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
Indications for Use: 1070478
Device Name
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
Device Name
P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
| 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
Susan Russer
ision Sign-Off) vision of Anesthesiology, General Hospital, Infection Control, Dental Devices
Number: K670478
510(k) Submission: P.004 Temporary Abutments February 16, 2007
Straumann US Page 11 of 36
Proprietary and Confidential