(74 days)
GC FujiCem
Not Found
No
The summary describes a dental cement with physical and chemical properties, and its intended use for luting dental restorations. There is no mention of any computational analysis, image processing, or learning algorithms.
No
The device is a dental cement used for luting various dental prosthetics. Its function is to bond these devices to tooth structures, which is a structural and restorative function, not a therapeutic one aimed at treating or preventing a disease or condition.
No
The device is a dental luting cement used for bonding dental restorations and appliances, not for diagnosing medical conditions.
No
The device is a dental cement, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BisCem GI's Intended Use: The intended use of BisCem GI is clearly described as a luting cement for dental restorations and appliances. This involves physically bonding materials within the mouth.
- Lack of Biological Sample Analysis: The description of BisCem GI and its intended use does not involve the analysis of any biological samples from the patient. It is a material used for a physical process (cementing).
Therefore, based on the provided information, BisCem GI is a dental material used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-tometal and composite-to-metal varieties;
- Luting resin crowns, bridges, inlays, onlays and veneers; 2.
-
- Luting metal or non-metal posts;
-
- Luting orthodontic appliances;
-
- Luting porcelain inlays.
Product codes (comma separated list FDA assigned to the subject device)
EMA, KLE, and DYH
Device Description
BisCem GI is a dual-cured resin modified glass ionomer cement. It is a self-adhesion cement bonding to composite, metal, silanated porcelain and tooth structure without applying any adhesive. For bonding to dentin and enamel, no etching step is required. With its dual syringe system, BisCem GI can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly.
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)
BisCem GI was tested for biocompatibility and it was found to be non-toxic.
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.
GC FujiCem
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
510 (k) submission for BisCem GI BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193
CONFIDENTIAL
Page 5-1
Section 5
NOV - 4 2003
510 (k) SUMMARY
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
Trade Name: BisCem GI
Common Name: Luting cement
Classification/Name: Material, Dental Cement Class II per 21 CFR 872.3275
Description of Application Device:
BisCem GI is a dual-cured resin modified glass ionomer cement. It is a self-adhesion cement bonding to composite, metal, silanated porcelain and tooth structure without applying any adhesive. For bonding to dentin and enamel, no etching step is required. With its dual syringe system, BisCem GI can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly.
Intended uses of Applicant Device:
BisCem GI is a dual-cure radiopaque dental cement designed to be used as a luting cement. Its physical properties are similar to the predicate device and uses are identical.
Predicate Device: GC FujiCem
| BisCem GI | GC FUJICEM | |
|---|---|---|
| Intended use | Luting cement | Luting cement |
| Chemical composite | Dual-cured (light/self) dental | |
| glass filled, resin modified glass | ||
| ionomer cement | Self-cured dental glass filled, | |
| resin modified glass ionomer | ||
| cement | ||
| Mechanical/physical | ||
| properties | Low viscosity, dispensable | |
| composite | Low viscosity, dispensable | |
| composite |
Significant Performance Characteristics:
Side by side comparisons of BisCem GI to the predicate device GC FujiCem clearly demonstrates that the applicant device is substantially equivalent to the legally marked devices. BisCem GI was tested for biocompatibility and it was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BisCem GI.
Kathy Joung, Ph.D. Director of Quality Systems Telephone: 847-534-6106 Fax: 847-534-6111
1
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus with three lines representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2003
Dr. Kathy Joung Director of Quality Systems Bisco. Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K032597
Trade/Device Name: BisCem™ GI Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA, KLE, and DYH Dated: August 21, 2003 Received: August 29, 2003
Dear Dr. Joung:
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 – Kathy Joung, PhD
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 yours,
Susan Punnis
for Chris S. Liem, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) submission for BisCem Gl BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193
CONFIDENTIAL
Page 2-2
510(k) Number (if known):