(106 days)
Not Found
No
The provided text describes dental cements and their intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a dental cement intended for cementing temporary restorations and implants, and as a temporary filling material, which are not considered therapeutic actions.
No
Explanation: The device is a dental cement intended for cementing temporary restorations and implants, and as a temporary filling material. It does not perform any diagnostic function.
No
The device description clearly states it consists of "three different cements," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for cementing temporary and semi-permanent dental restorations and as temporary filling materials. This is a direct application within the body (or on a part of the body, like teeth), not for testing samples taken from the body.
- Device Description: The description reinforces the intended use as dental cements and filling materials.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials
Product codes
EMA
Device Description
Provi Cem Esthetic consist of three different cements: DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations; DC Provi Cem Implant: Intended for cementing of semi-permanent implants; All cements can also be used as temporary filling materials
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)
Tempbond Clear, K982590
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
12. Summary of Safety and Effectiveness
SEP 2 5 2009
Submitter
Name of company: S&C Polymer Silicon- und Composite Spezialitaeten GmbH Address: Robert-Bosch-Strasse 5, D-25335 Elmshorn (Germany) Phone: 0049 4121 483 0 Fax: 0049 4121 483 184 Contact Person: Dr. Christian Boettcher Date of preparation: June 2009
Device Name:
Trade name: Provi Cem Esthetic
Common Name: Provi Cem Esthetic (consisting of DC Provi Cem Esthetic, DC Provi Cem Esthetic Multi F and DC Provi Cem Implant)
Classification Name: Cement Dental, per 21CFR § 872.3275
Devices for which Substantial Equivalence is Claimed:
Tempbond Clear, K982590
Device description and Intended Use of the device:
Provi Cem Esthetic consist of three different cements:
DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F: Intended for cementing temporary restorations such as crowns, bridges, inlays or onlays; as well as for trial cementing of permanent restorations;
DC Provi Cem Implant: Intended for cementing of semi-permanent implants;
All cements can also be used as temporary filling materials
Substantial Equivalence:
Provi Cem Esthetic is substantially equivalent to other legally marketed devices in the United States. The Cements marketed by S&C Polymer Silicon- und Compositen Spezialitaeten GmbH function in a manner similar to and is intended for the same use as the products marketed by Sybron Dental Specialities, Inc.
1
Image /page/1/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 bars above its head, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
SEP 2 5 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Dr. Christian Boettcher Official Correspondent S& C Polymer GmbH Robert-Bosch -Strasse 5 Elmshorn, Germany D-25335
K091735 Re:
Trade/Device Name: Provi Cem Esthetic (DC PROVI Cem Esthetic, DC Provi Cem . Esthetic Multi F, and DC Provi Cem Implant)
Regulation Number: 21 CFR 872,3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 11, 2009 Received: September 15, 2009
Dear Dr. Boettcher:
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 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- Dr. Boettcher
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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
10. Statement of Indication for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Provi Cem Esthetic (consisting of three different cements):
DC Provi Cem Esthetic and DC Provi Cem Esthetic Multi F:
Intended for cementing temporary restorations such as crowns, bridges inlays or onlays; as well as for trial cementing of permanent restorations;
DC Provi Cem Implant:
Intended for cementing of semi-permanent implants;
all cements can also be used as temporary filling materials
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Haley for MSR
Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
10(k) Number: K0911735
Prescription Use:
or
Over-The-Counter Use