(77 days)
Not Found
No
The summary describes a light-cured resin formulation and its intended use for sealing and polishing. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The focus is on the chemical properties and performance of the resin itself.
No
This device is a resin formulation used to seal and polish dental surfaces and restorations, which is a restorative and protective function, not a therapeutic one that treats disease or medical conditions.
No
The device, BISCOVER LV, is a resin formulation used to seal and polish dental restorations and enamel. Its intended use is to provide a smooth, polished surface and it does not perform any diagnostic function such as detecting, identifying, or monitoring disease.
No
The device description clearly states it is a "low-viscosity, light-cured resin formulation," indicating it 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 use of BISCOVER LV is to seal and polish dental restorations and enamel. This is a direct application to a patient's teeth for a physical effect (sealing and polishing).
- Device Description: The description reinforces its use as a resin formulation applied to surfaces.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
- Anatomical Site: The anatomical site is enamel, which is part of the patient's body, not a sample taken from the body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. BISCOVER LV does not fit this description.
N/A
Intended Use / Indications for Use
BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
BISCOVER LV is used to Seal and Polish:
-
- Direct composites (cured)
-
- Indirect composites
-
- Provisionals
-
- Acrylic appliances
-
- Resin-modified Glass Ionomers
-
- Enamel before or after orthodontic bracket placement
-
- Etched Enamel
Product codes
EBD
Device Description
BISCOVER LV is a low viscosity, light-cured resin formulation used to seal restorations and etched enamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LV cures without any sticky oxygen-inhibited layer. BISCOVER LV may reduce or even eliminate the need for manual polishing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Enamel, Dental restorations (composites, provisionals, resin-modified glass ionomers)
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 LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LV was tested for biocompatibility and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the date "FEB - 1 2005" at the top. Below the date is a handwritten number, "K043168". The date is printed in a simple, sans-serif font, while the number is written in a cursive style. The image appears to be a scan or photocopy of a document.
Page 5-1
Section 5 510 (k) SUMMARY
| 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: | November 15, 2004 |
| Trade Name: | BISCOVER LV |
| Common Name: | Surface Sealant |
| Classification/Name: | Coating Material for Resin Fillings
Class II per 21 CFR 872.3310 |
Description of Applicant Device:
BISCOVER LV is a low viscosity, light-cured resin formulation used to seal restorations and etched enamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LV cures without any sticky oxygen-inhibited layer. BISCOVER LV may reduce or even eliminate the need for manual polishing.
Intended uses of Applicant Device:
BISCOVER LV is used to seal and polish direct composites (cured), indirect composites, provisionals, acrylig appliances, Resin-Modified Glass Ionomers, Enamel before or after orthodontic bracement, and etched Enamel.
Predicate Devices: BISCOVER Liquid Polish (K030354) dated February 19, 2003.
Significant Performance Characteristics:
BISCOVER LV to BISCOVER Liquid Polish
| Property | BISCOVER | BISCOVER LV |
|---|---|---|
| Intended use | Resin sealant | Resin sealant |
| Chemical composition | Light-Cured, Multifunctional | |
| Acrylate Resin | Light-Cured, Multifunctional | |
| Acrylate Resin | ||
| Mechanical /physical | ||
| properties | Low viscosity clear resin liquid | |
| light cured to smooth polish | ||
| surface | Low viscosity clear resin liquid | |
| light cured to smooth polish | ||
| surface |
Side by side comparisons of BISCOVER LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LV was tested for biocompatibility and was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of BISCOVER LV.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, stacked on top of each other.
Public Health Service
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K043168
Trade/Device Name: BISCOVER LV Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: January 24, 2005 Received: January 25, 2005
Dear Mr. Lichtenwalner:
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 approvisions 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 (1 Nr.), It may of buryer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear roublish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Lichtenwalner
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act FDA has made a determination that your device complies with other requirements moan that I Dr I has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bakes and squirements, including, but not limited to: registration 1 ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirences as bet ferin in all of 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) I mis letter will and in Jorde FDA finding of substantial equivalence of your device to a premarket notification - I s 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), If you desire specific at no a compliance at (240) 276-0115. 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 from the may obtain other generational 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,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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):
BISCOVER LV Device Name:
Indications for Use:
BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
BISCOVER LV is used to Seal and Polish:
-
- Direct composites (cured)
-
- Indirect composites
-
- Provisionals
-
- Acrylic appliances
-
- Resin-modified Glass Ionomers
-
- Enamel before or after orthodontic bracket placement
-
- Etched Enamel
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)
Super Ruma
Offision Sign-Off) ്സടിന്ന Sign-Only
Olvision of Anesthesiology, General Hospital, Inrection Control. Dental Devices
310(k) Number K043161