(74 days)
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No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No.
The device is described as an insoluble cement for cementing dental prosthetics, which serves a structural rather than a therapeutic function.
No
Explanation: The device is described as an insoluble cement for dental restorations and orthodontic applications, which is a therapeutic or restorative function, not a diagnostic one. It does not mention analyzing data or imaging to identify diseases or conditions.
No
The device description clearly states it is a "dental glass ionomer cement," which is a physical material, not software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of PhoGlass Cem is for cementing dental restorations (crowns, bridges, etc.) and as a base or liner. This is a therapeutic or restorative application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a dental glass ionomer cement used for these cementing purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are used to perform tests in vitro (outside the living body) on specimens derived from the human body to provide information for diagnostic purposes. PhoGlass Cem is used in vivo (within the living body) for a restorative purpose.
N/A
Intended Use / Indications for Use
PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
Product codes
EMA, EJK
Device Description
PhoGlass Cem is a dental glass ionomer cement intended to be used as an cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Fuji I (GC Corporation)
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
13. Summary of Safety and Effectiveness
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: December 2008
Device Name:
Trade name: PhoGlass Cem Common Name: PhoGlass Cem Classification Name: Cement Dental, per 21CFR § 872.3275
Devices for which Substantial Equivalence is Claimed:
Fuji I (GC Corporation)
Device description:
PhoGlass Cem is a dental glass ionomer cement intended to be used as an cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
Intended Use of the Device:
The device is designed for cementing-applications for dental purposes.
Substantial Equivalence:
PhoGlass is substantially equivalent to other legally marketed devices in the United States. The products 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 product marketed by GC.
MAR - 2 2009
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Christian Boettcher Regulatory Compliance Officer S&C Polymer GmbH Robert-Bosch-Strasse 5 D-25335 Elmshorn GERMANY
MAR - 2 2009
Re: K083766
Trade/Device Name: PhoGlass Cem Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA and EJK Dated: December 17, 2008 Received: December 22, 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
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 (OS) 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 vour 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" (21 CFR 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,
Grytte H. Michie Oms.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
11. Statement of Indication for Use
510(k) Number (if known):
Device Name:
PhoGlass Cem
Indications for Use:
PhoGlass Cem:
PhoGlass Cem is intended to be used as an insoluble cement for cementing of crowns and bridges, inlays and onlays (metal and ceramic fused to metal), stainless steel crowns, orthodontic bands and used as a base or a liner.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sipe Runser
Offsion Sign-Off) Onnson of Anesthesiology, General Hospital mecuon Control, Dental Devices
Number: K0837/06
Prescription Use:
or
Over-The-Counter Use