(80 days)
Not Found
No
The device description details the chemical composition of dental cements and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as a cement for dental restorations (crowns and bridges) and a temporary filling material, which serves a structural or restorative purpose rather than a therapeutic one (i.e., treating a disease or condition).
No
The device, Zinc Oxide Cem, is described as a cement for temporary or permanent cementation of crowns and bridges, and as a temporary filling material. Its function is to physically bond dental prostheses/materials to teeth, not to diagnose a condition or disease.
No
The device description clearly states it consists of a liquid and a powder, which are physical components, not software.
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 temporary or permanent cementation of crowns and bridges on non-vital teeth and as a temporary filling material. This is a direct application within the mouth for dental restoration and fixation.
- Device Description: The device is a dental cement consisting of a liquid and a powder that are mixed together.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to gain information about a person's health. This device is used directly on the patient's teeth for a restorative purpose.
N/A
Intended Use / Indications for Use
Carboxylate Cem: Cementation of crowns and bridges on non-vital teeth where retention is of primary concern. Also for use as a temporary filling material.
Phosphate Cem: For permanent cementation of crowns and bridges on non-vital teeth where the use of conventional Zinc phosphate cements is judged appropriate
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Zinc Oxide Cem consist of two different cements:
Carboxylate Cem consists of a polyacrylic/water contairing liquid and a zinc oxide/magnesiumoxide containing powder.
Phosphate Cem consists of a phosphoric acid/water containing liquid and a zinc oxide/magnesiumoxide containing powder.
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
§ 872.3275 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
Summary of Safety and Effectivenesss 11.
SEP - 5 2006
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 2008
Device Name:
Trade name: Zinc Oxide Cem Common Name: Zinc Oxide Cement (consisting of Carboxylate Cem and Phosphate Cem) Classification Name: Cement Dental, per 21CFR § 87.2.3275
Devices for which Substantial Equivalence is Claimed:
Carboxylate Cem: Carbocem Zinc Polycarboxylate Cernent, Scientific Pharmaceuticlas Inc., K993324 Phosphate Cem: Zinc Phosphate Cement, Scientific Pharmaceuticias Inc., K982913
Device description:
Zinc Oxide Cem consist of two different cements:
Carboxylate Cem consists of a polyacrylic/water contairing liquid and a zinc oxide/magnesiumoxide containing powder.
Phosphate Cem consists of a phosphoric acid/water containing liquid and a zinc oxide/magnesiumoxide containing powder.
Intended Use of the Device:
Carboxylate Cem. Cementation of crowns and bridges on non-vital teeth where retention is of primary concern. Also for use as a temporary filling material.
Phosphate Cem: For permanent cementation of crowns and bridges on non-vital teeth where the use of conventional Zinc phosphate cements is judged appropriate
Substantial Equivalence:
Zinc Oxide Cem 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 sam use as the products marketed by Scientific Pharmaceuticals Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Dr. Christian Boettcher Regulatory Compliance Officer S & C Polymer Silicon-Und Composite Spezialitaeten GmbH Robert-Bosch-Strasse 5 Elmshorn, Schleswig-Holstein 25335 GERMANY
Re: K081702
Trade/Device Name: Carboxylate Cem, Phosphate Cem Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 12, 2008 Received: June 17, 2008
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 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 - 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
JK. Ammuler Lend my forth
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
hos nor
9. Statement of Indication for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Zinc Oxide Cem
Carboxylate Cem:
For temporary or permanent cementation of crowns and bridges on non-vital teeth where retention is of primary concern. Also for use as a ternporary filling material.
Phosphate Cem:
For permanent cementation of crowns and bridges on non-vital teeth where the use of conventional Zinc phosphate cernents is judged appropriate.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swxal Kumara
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. kC81702
Prescription Use:
Over-The-Counter Use