(30 days)
Not Found
No
The summary describes standard dental implant components (healing abutments and closure screws) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to maintain, stabilize, and form soft tissue during the healing process, which is a therapeutic function.
No
The device description indicates that healing abutments and closure screws are used to protect the inner configuration of an implant and to maintain, stabilize, and form soft tissue during the healing process following dental implant surgery. These functions are therapeutic and protective, not diagnostic.
No
The device description clearly states that the device covered in this submission is "healing abutments and closure screws," which are physical components of a dental implant system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used with a dental implant system to protect the implant's inner configuration and manage soft tissue during healing. This is a direct interaction with the patient's body for a therapeutic purpose (healing and tissue formation).
- Device Description: The description reinforces that these are physical components used in conjunction with dental implants for surgical and prosthetic purposes.
- 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 samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as part of a surgical and healing process.
N/A
Intended Use / Indications for Use
P.004 Healing Abutments and P.004 Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann 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 device covered in this submission is healing abutments and closure screws.
Healing abutments and closure screws are used to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process
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): 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.
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.)
0
Section H 510(k) Summary
JUL 1 1 2007
1. Applicant's Name and Address Straumann USA (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
2. Name of the Device
| Trade Name: | NC Healing Abutments, NC Closure Screws |
|---|---|
| Common Name: | Abutment, Dental, Endosseous implants |
| Classification Name: | Abutment, Dental, Endosseous implants |
| §21 CFR 872.3630 |
3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
P.004 RC Healing Abutments, K062129 P.004 RC Closure Screws, K062129
4. Description of the Device
The Straumann 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 device covered in this submission is healing abutments and closure screws.
Healing abutments and closure screws are used to protect the inner configuration of the implant and to maintain, stabilize and form the soft tissue. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process
5. Intended Use of the Device
P.004 Healing Abutments and P.004 Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.
1
202
6. Basis for Substantial Equivalence
The modified NC Healing Abutments and Closure Screws are substantially equivalent to the currently marketed RC Healing Abutments and closure screws. The intended use is identical to the predicate devices. The proposed abutments and closure screws have 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 Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is black and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2007
Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA (on behalf of Institut Straumann AG) 60 Minuteman Road Andover, Massachusetts 01810
Re: K071585
Trade/Device Name: P.004 Healing Abutments and Closure Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 8, 2007 Received: June 11, 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,
Clu
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 Healing Abutments and Closure Screws
Indications for Use:
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Kira Hulsey for MSR
(Division Sign-Utl) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K07 |5 85
510(k) Submission: P.004 NC Healing Abutments June 8, 2007 Proprietary and Confidential Straumann US Page 5-43