(88 days)
Not Found
No
The summary describes a physical dental coping and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a coping intended to serve as a base for a temporary restoration, which is a structural component of a dental restoration, not a device that provides a therapeutic effect.
No
The device is a coping intended to serve as a base for a temporary restoration, which is a treatment and not a diagnostic function.
No
The device description clearly states it is a "coping" which is a physical component, not software.
Based on the provided information, the Straumann Temporary Coping is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to serve as a base for a temporary restoration, which is a dental procedure performed directly on a patient.
- Device Description: The description details a physical component used in a dental restoration process.
- 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 specifically designed for testing biological samples outside of the body. The Straumann Temporary Coping is a medical device used within the body during a dental procedure.
N/A
Intended Use / Indications for Use
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.
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
KC41070
ATTACHMENT 1 - 510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
Applicant's Name and Address .
→ :
Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Linda Jalbert Contact Person: Director, Requiatory Affairs
2. Name of the Device
| Proposed Trade Name: | Straumann Temporary Coping |
|---|---|
| Common Name: | Temporary coping |
| Classification Name: | Accessory to Dental Implant Abutment, NHA |
Legally Marketed Devices to which Equivalence is Claimed (Predicate ന് Devices)
| Manufacturer | Device | 510(k) |
|---|---|---|
| Simplified | ||
| Implant Systems | Universal Dental Coping | K010467 |
| Centerpulse | ||
| Dental | Hex-Lock Temporary Abutment | K014050 |
| Friadent | ProTect Abutment | Unknown |
| Lifecore | COC Abutment Temporary Cap | Unknown |
Description of the Device and Intended Use ব :
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.
5. Basis for Substantial Equivalence
The Straumann Temporary Coping is substantially equivalent to the predicate devices since it has a similar design and the same intended use. Like all of the predicate devices, the subject device functions as a base for a temporary restoration. Acrylic or composite material is added over the coping to form the temporary restoration.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Ms. Linda Jalbert Vice President, Regulatory & Clinical Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451
Re: K041070
Trade/Device Name: Straumann Temporary Coping Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: April 23, 2004 Received: April 26, 2004
Dear Ms. Jalbert:
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.
2
Page 2 - Ms. Jalbert
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susa Lumer
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
3
Indications for Use
510(k) Number (if known):
Device Name: Temporary Coping
Indications For Use:
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
× 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)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control Dental Devices
Page 1 of 1
510(k) Number: K041070