(171 days)
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No
The summary describes a system of dental materials (glass ionomer cements, conditioner, protective coating) and their intended uses, with no mention of AI or ML technology.
No.
The device is a dental restorative material used for filling, core build-up, and sealing applications, which are generally considered structural and protective procedures rather than therapeutic interventions aimed at treating a disease or disorder.
No
The "Intended Use / Indications for Use" section describes the device as a "System for the restoration of cavities" and various "filling cement" applications, "core build-up cement," and "sealing cement." These are all therapeutic or restorative functions, not diagnostic ones.
No
The device description explicitly states it is a "Glass Ionomer restorative dental material," which is a physical substance, 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 describes the device as a dental material for restoring cavities, core build-ups, sealing, conditioning, and protecting dental structures. These are all procedures performed directly on the patient's teeth.
- Device Description: The device is described as a "Glass Ionomer restorative dental material." This is a material used in dental procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used to perform tests in vitro (outside the living body) on specimens derived from the human body. This device is used in vivo (within the living body) as a restorative and protective material.
N/A
Intended Use / Indications for Use
PhoGlass is a system consisting of a Glass Ionomer restorative dental material suitable for restorative, core build-up-, and sealing-purposes. In addition it contains a dentinel engmel conditioner and a liquid suitable for protective coatings of the restorations.
System for the restoration of cavities, also suitable for , core-build-up- and sealing applications. Conditioning of dentin and enamel and protecting of restored areas.
PhoGlass Fill:
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class | III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups.
PhoGlass Core:
PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings.
PhoGlass Seal:
PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for interroediate restorations of lesions.
PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure.
PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.
Product codes
EBF, EBL, LBH
Device Description
PhoGlass is a system consisting of a Glass Ionomer restorative dental material suitable for restorative, core build-up-, and sealing-purposes. In addition it contains a dentinel engmel conditioner and a liquid suitable for protective coatings of the restorations.
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)
Fuji IX GP Extra, Fuji VII, GC Dentin Conditioner, GC Fuji Varnish
Reference Device(s)
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 Effectiveness 11.
Submitter
Name of company: S&C Polymer Silicon- und Composite Spezialitaeten GmbH Address: Robert-Bosch-Strasse 5, D-25335 Elmshom (Germany) Phone: 0049 4121 483 0 Fax: 0049 4121 483 184 Contact Person: Dr. Christian Boettcher
Date of preparation: July 2008
Device Name:
Trade name: PhoGlass Common Name: PhoGlass (consisting of Fill, Core, Seal, Prime and Protect) Classification Name: Cement Dental, per 21CFR § 872.3275
Devices for which Substantial Equivalence is Claimed:
PhoGlass Fill: Fuji IX GP Extra / PhoGlass Core: Fuji IX GP Extra PhoGlass Seal: Fuji VII / PhoGlass Prime: GC Dentin Conditioner PhoGlass Protect: GC Fuji Varnish
Device description:
PhoGlass is a system consisting of a Glass lonomer restorative dental material suitable for restorative, core build-up-, and sealing-purposes. In addition it contains a dentinel engmel conditioner and a liquid suitable for protective coatings of the restorations
Intended Use of the Device:
System for the restoration of cavities, also suitable for , core-build-up- and sealing applications. Conditioning of dentin and enamel and protecting of restored areas.
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 products marketed by GC.
JAN 1 5 2009
1
PhoGlass Prime:
PhoGlass Prime is intended to be used as a conditioner for dentin and enamel to enhance the bond between the cements and the tooth structure.
PhoGlass Protect:
PhoGlass Protect is intended for protecting PhoGlass restorations from exposure to moisture.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: Yes
ог
Over-The-Counter Use: No
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The text is in all capital letters and is written in a sans-serif font. The logo is black and white.
Public Health Service
od and Drug Administration 00 Corporate Boulevard ockville MD 20850
Di Chistian Boettcher Official Correspondent S & C Polymer GmbH Robert-Bosch- Strasse 5 1)-25335 Elmshorn, Germany
JAN 1 5 2009
Rc: K082115
Trade/Device Name: PhoGlass Fill, Core, Scal, Prime and PhoGlass Protect Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II. Product Code: EBF, EBL, LBH Dated: December 17, 2008 Received: December 18, 2008
Dear Dr Boettcher:
We have reviewed your Section 510(k) premarket notification of intent to market the device I eferenced 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.
It 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.
3
Page 2 - Dr. Boettcher
Please be advised that FDA's issuance of a substantial equivalence determination does not I least 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 I>wision 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) 276-3 1 50 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony V. Martin Jr.
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
4
Statement of Indication for Use 9.
510(k) Number (if known):
K 082115
Device Name:
PhoGlass
Indications for Use:
PhoGlass Fill:
PhoGlass Fill is intended to be used as an insoluble filling cement for uniplanar fillings of class | III and V cavities, for primary tooth fillings, for linings of composite fillings and also for core build-ups.
PhoGlass Core:
PhoGlass Core is intended to be used as an insoluble core build-up cement and for underlinings of composite fillings.
PhoGlass Seal:
PhoGlass Seal is intended to be used as an insoluble sealing cement for hypersensitivity prevention and control, for root surface protection, for fissure protection and for interroediate restorations of lesions.
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
eal Number. k