(74 days)
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.
- Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
- Luting resin crowns, bridges, inlays, onlays and veneers;
- Luting metal or non-metal posts;
- Luting orthodontic appliances;
- Luting porcelain inlays.
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.
This is a 510(k) summary for a dental luting cement, BisCem GI. It is a submission to demonstrate substantial equivalence to a predicate device, GC FujiCem. In such submissions, the acceptance criteria relates to the equivalence of physical properties and intended uses compared to the predicate device, rather than a clinical study with specific performance metrics like sensitivity/specificity for diagnostic AI devices.
Here's an analysis based on the provided text, structured according to your request, but acknowledging the nature of this particular device and submission type:
Acceptance Criteria and Device Performance (Based on 510(k) Summary for BisCem GI)
Given that this is a 510(k) submission for a dental luting cement, the "acceptance criteria" is primarily the demonstration of "substantial equivalence" to a legally marketed predicate device (GC FujiCem) in terms of intended use, chemical composition, and mechanical/physical properties. Performance here refers to these comparative characteristics rather than statistical metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria for Substantial Equivalence | BisCem GI (Applicant Device) Performance | GC FujiCem (Predicate Device) Performance | Acceptance/Equivalence |
|---|---|---|---|
| Intended Use | Luting cement | Luting cement | Met (Identical) |
| Chemical Composition | Dual-cured (light/self) dental glass filled, resin modified glass ionomer cement | Self-cured dental glass filled, resin modified glass ionomer cement | Met (Similar, with an additional dual-cure feature) |
| Mechanical/Physical Properties | Low viscosity, dispensable composite | Low viscosity, dispensable composite | Met (Similar) |
| Biocompatibility | Found to be non-toxic | Not explicitly detailed for predicate device in summary, but implied acceptable. | Met (Tested and found non-toxic) |
Study Proving Acceptance Criteria:
The document states: "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."
This indicates that a comparative study was performed to assess the physical and chemical characteristics of BisCem GI against GC FujiCem. The specific methodology for these comparisons (e.g., standardized testing protocols for viscosity, bond strength, wear resistance, etc.) is not detailed in this summary.
Regarding the specific points requested for AI/Diagnostic Device Studies:
The provided document describes a 510(k) submission for a dental material (luting cement), not an AI algorithm or a diagnostic device. Therefore, many of the requested points related to AI/diagnostic study design are not applicable to this type of submission.
2. Sample size used for the test set and the data provenance: Not applicable for this type of device. The "test set" would refer to material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a luting cement relates to its physical/chemical properties, established through laboratory testing rather than expert-labeled data.
4. Adjudication method for the test set: Not applicable. Material properties are measured, not adjudicated.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a dental luting cement, the "ground truth" for proving substantial equivalence involves established scientific methods and standards for measuring material properties (e.g., bond strength, setting time, solubility, compressive strength, biocompatibility according to ISO standards). The document mentions "biocompatibility" testing, concluding it was "non-toxic."
8. The sample size for the training set: Not applicable (no "training set" for physical material properties).
9. How the ground truth for the training set was established: Not applicable (no "training set" in this context).
Summary of Device and Acceptance:
BisCem GI is a dual-cured resin modified glass ionomer cement. Its intended use is as a luting cement for various dental restorations (metal/resin crowns, bridges, inlays, onlays, veneers, posts, orthodontic appliances, porcelain inlays).
The device met the acceptance criteria for substantial equivalence to its predicate device, GC FujiCem, by demonstrating similar intended uses, comparable chemical composition (with an additional dual-cure feature), and similar mechanical/physical properties (low viscosity, dispensable composite), as well as being found non-toxic in biocompatibility testing. The submission concludes that this information proves the safety and efficacy of BisCem GI, leading to its clearance by the FDA.
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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) dentalglass filled, resin modified glassionomer cement | Self-cured dental glass filled,resin modified glass ionomercement |
| Mechanical/physicalproperties | Low viscosity, dispensablecomposite | Low viscosity, dispensablecomposite |
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
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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.
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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
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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): <032597
Device Name: BisCem GI
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.
(PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suer Purser
(Division Sign-General Hospital, Division of Anesthesion Infection Control,
510(k) Number
(Optional Format 3-10-98)
§ 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.