(16 days)
Not Found
No
The device description and performance studies focus on the chemical composition and sealing properties of a liquid polish, with no mention of AI or ML.
No
The device is described as a liquid polish used to seal surfaces of restorations and appliances, which is a structural or protective function, not a therapeutic one. It does not treat a disease or condition.
No
This device is a surface sealant for various dental restorations and prostheses, not a tool for diagnosing medical conditions.
No
The device description clearly states the device is a liquid polish composed of chemical ingredients and supplied in a bottle, applied with a brush. This indicates a physical product, 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 states that the device is used to "SEAL THE SURFACE OF" various dental and prosthetic materials. This is a direct application to materials outside of the body, not for testing or analyzing samples taken from the body.
- Device Description: The description details the chemical composition and how it is applied to seal surfaces. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Measuring analytes or biomarkers
- Use in a laboratory setting for testing
The device is a dental material used for sealing and polishing, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TO SEAL THE SURFACE OF:
DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLINTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS
Product codes (comma separated list FDA assigned to the subject device)
EBD
Device Description
BISCOVER LIQUID POLISH contains Hexafunctional Urethane Acrylate (30%), Polyethylene Glycol Diacrylate (26%), Ethoxylated Bisphenol A Diacrylate (34%), Trifunctional Acid Ester (3%), TPO (7%), MEHQ (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration. BISCOVER VISCOSITY MODIFIER is acetone and is used to reduce the thickness of the BISCOVER LIQUID POLISH.
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)
Side by side comparisons of BISCOVER LIQUID POLISH to the predicate device FORTIFY clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of BISCOVER LIQUID POLISH were tested for biocompatibility and were found to be nontoxic.
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.
Fortify K882915
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
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
FEB 1 9 2003
Image /page/0/Picture/1 description: The image shows the logo for BISCO, a company specializing in adhesive and composite technology. The logo consists of six hexagons arranged in a row, with the letters "B", "I", "S", "C", and "O" inside the first five hexagons. Below the hexagons, the text "Specialist In Adhesive and Composite Technology" is printed in a smaller font.
Bisco, Inc.
1100 W. Irving Park Road, Schaumburg, IL. 60193 U.S.A. Telephone: (847) 534-6000 or 1-800-BIS-DENT Fax: (847) 534-6396 WEB SITE http://www.bisco.com
Contact: Stephen D. Smith
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:
BISCOVER LIQUID POLISH KIT, AND BISCOVER VISCOSITY MODIFIER Surface Sealant
Common Name: Classification name:
Material, Tooth Shade, Resin Class II per 21 CFR 872.3690
Description of Applicant Device:
BISCOVER LIQUID POLISH contains Hexafunctional Urethane Acrylate (30%), Polyethylene Glycol Diacrylate (26%), Ethoxylated Bisphenol A Diacrylate (34%), Trifunctional Acid Ester (3%), TPO (7%), MEHQ (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration. BISCOVER VISCOSITY MODIFIER is acetone and is used to reduce the thickness of the BISCOVER LIQUID POLISH.
Intended uses of Applicant Device:
To seal the surface of: direct and indirect composite restorations, provisional restorations, and amalgam restorations.
Predicate Devices: Fortify K882915 cleared by FDA on 08/12/88
Significant Performance Characteristics:
| UNINHIBITED | FORTIFY | |
|---|---|---|
| Intended Use | Resin sealant. | Resin sealant. |
| Product | ||
| Description | Clear solution. | Clear solution. |
| Delivery System | Brush | Brush |
Side by side comparisons of BISCOVER LIQUID POLISH to the predicate device FORTIFY clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. The ingredients of BISCOVER LIQUID POLISH were tested for biocompatibility and were found to be nontoxic.
It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LIQUID POLISH.
Stephen D. Smith Manager Regulatory Affairs 847 534-6146
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them that resemble hair or a stylized representation of the human spirit.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2003
Mr. Steve Smith Manager of Regulatory Affairs Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K030354
Trade/Device Name: BIScover™ Liquid Polish Kit, BIScover Liquid Polish, And BIScover Viscosity Modifier Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 31, 2003 Received: February 03, 2003
Dear Mr. Smith:
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 -- Mr. Steve Smith
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 Runer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page of
510(k) Number (if known): K030354
BISCOVER LIQUID POLISH KIT, Device Name:__________________________________________________________________________________________________________________________________________________________________ BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER Indications For Use:
TO SEAL THE SURFACE OF:
DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLINTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Kein Muly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: X 030354