(13 days)
Not Found
Not Found
No
The summary describes a cold-polymerizing paste-paste system, a material used for temporary dental restorations, with no mention of software, image processing, or AI/ML terms.
No
The device is a material used for preparing temporary dental restorations, which is a structural rather than a therapeutic function. Therapeutic devices are typically those that treat or prevent disease.
No
The device is described as a "cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays," which indicates it is used for restorative dental procedures, not for diagnosing conditions.
No
The device is described as a "cold-polymerizing paste-paste system," which indicates it is a physical material used for dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation of temporary dental restorations (crowns, bridges, inlays, onlays). This is a direct application within the patient's mouth or on models of the patient's mouth, not for testing samples in vitro (outside the body).
- Device Description: It's a cold-polymerizing paste-paste system, which is consistent with dental materials used for creating temporary restorations.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays
Product codes
EBG
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 7 2004
VOCO GmbH C/O Mr. Gerald W. Shipps Cascades Device Consulting Associates 19379 Blue Lake Loop Bend. Oregon 97702
Re: K040769
Trade/Device Name: Structur 2 SC Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: March 23, 2004 Received: March 26, 2004
Dear Mr. Shipps:
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.
1
Page 2 - Mr. Shipps
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 vours.
fth h
feo,
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
2
Indications for Use Statement
510(k) Number: _Ko ப 676 ப பு
Device Name: Structur 2 SC ________
Indications for Use:
cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Robert Betz DDS for Dr. S. Kummer
510(k) Number: KC040769