(60 days)
Not Found
No
The description focuses on the chemical and physical properties of a dental cement and its application as a luting agent. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML.
No
The device is a resin cement used for luting (bonding) dental restorations and orthodontic appliances. Its function is mechanical bonding, not treating a disease or condition.
No
This device is a dental luting cement used for bonding various dental prosthetics; it does not diagnose medical conditions.
No
The device description clearly states that BisCem is a "dual-cured self etching and self adhesive resin 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 uses listed are all related to luting (cementing) various dental restorations and appliances within the patient's mouth. This is a direct application to the body for a therapeutic or restorative purpose.
- Device Description: The description confirms it's a resin cement used for bonding dental materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, BisCem, as described, falls under the category of a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BisCem is a dual-cure radiopaque dental cement designed to be used as a luting cement. Its physical properties and uses are similar to the predicate device.
- 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/fiber posts;
- Luting orthodontic appliances;
- Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
BisCem is a dual-cured self etching and self adhesive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system, BisCem 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. It is intended for use as a luting cement.
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 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.
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
060701
Section 5 510 (k) SUMMARY
"" + 5 more
| Applicant: | Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193 |
|----------------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner
Tel: 847-534-6146
Fax: 847-534-6111 |
| Date Prepared: | March 15, 2006 |
| Trade Name: | BisCem |
| Common Name: | Luting Cement |
| Classification/Name: | Material, Dental Cement
Class II per 21 CFR 872.3275 |
Description of Applicant Device:
BisCem is a dual-cured self etching and self adhesive resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system, BisCem 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. It is intended for use as a luting cement.
Intended uses of Applicant Device:
BisCem is a dual-cure radiopaque dental cement designed to be used as a luting cement. Its physical properties and uses are similar to the predicate device.
Predicate Devices: BisCem GI cleared under (K032597) dated November 4, 2003.
Significant Performance Characteristics:
| BisCem GI | BisCem | |
|---|---|---|
| Intended use | Luting cement | Luting cement |
| Chemical composite | Dual-cured (self/light) dental glass | |
| filled, resin modified glass ionomer | ||
| cement | Dual-cured (self/light) dental | |
| glass filled, resin cement | ||
| Mechanical /physical properties | Low viscosity, dispensable | |
| composite | Low viscosity, dispensable | |
| composite |
Side by side comparisons of BisCem to the predicate device BisCem GI clearly demonstrates that the applicant device is substantially equivalent to the legally marked device. BisCem 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Ser
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2006
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K060701
Trade/Device Name: BisCem Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 02, 2006 Received: May 05, 2006
Dear Mr. Lichtenwalner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levicwed your Section of the device is substantially equivalent (for the indications for releteed above and have decommised are of cated predicate devices marketed in interstate commerce use stated in the encreasure) to regain than of the Medical Device Amendments, or to devices that provision in the provisions in the provisions of the Federal Food, Drug, Drug, and Cosmetic liave been roomsonied in are approval of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, market the do need, basyev remirements for annual registration, listing of devices, good controls provide or assess on prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may or subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
2
Page 2 - Mr. Benjamin Lichtenwalner
Please he 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 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylette Y. Michine Om-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) Number (if known):
BISCEM Device Name:
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;
-
- Luting metal or non-metal/fiber posts;
-
- Luting orthodontic appliances;
-
- Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runo
Sizm-Chi) in of Anesthesiology, General Hospital, tion Control, Dental Devices
00070