(28 days)
Not Found
No
The device description and performance studies focus on the chemical formulation and curing properties of a resin, with no mention of AI or ML technologies.
No
This device is a dental sealant used to polish and seal restorations and enamel, which falls under general dental care and not therapeutic intervention.
No
The device description and intended use state that BISCOVER LED is a resin formulation used to seal and polish dental surfaces and restorations. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly states it is a "low-viscosity, light-cured resin formulation," 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 use of BISCOVER LED is to seal and polish dental restorations and enamel. This is a direct treatment or modification of the tooth structure, not a test performed on a sample taken from the body to provide information about a person's health.
- Device Description: The description details a light-cured resin formulation applied directly to the tooth. This aligns with a dental material used for restoration and sealing, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
Therefore, BISCOVER LED is a dental material used for restorative and protective purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
BISCOVER LED 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 (comma separated list FDA assigned to the subject device)
EBD
Device Description
BISCOVER LED is a low viscosity, light-cured resin formulation used to seal restorations and etched cnamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LED cures without any sticky oxygen-inhibited layer. BISCOVER LED may reduce or even eliminate the need for manual polishing. The photo-initiator used by BISCOVER LED allows most LD demal curing lights to achieve polymerization.
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
Prescription Use
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 LED to the predicate device BISCOVER LV clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LED 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 LED.
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.
BISCOVER LV (K043168)
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
AUG 2 2 2005
12051494
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: | July 20, 2005 |
| Trade Name: | BISCOVER LED |
| Common Name: | Surface Sealant |
| Classification/Name: | Tooth Shade Resin Material |
| Class II per 21 CFR 872.3310 |
Description of Applicant Device:
BISCOVER LED is a low viscosity, light-cured resin formulation used to seal restorations and etched cnamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LED cures without any sticky oxygen-inhibited layer. BISCOVER LED may reduce or even eliminate the need for manual polishing. The photo-initiator used by BISCOVER LED allows most LD demal curing lights to achieve polymerization.
Intended uses of Applicant Device:
BISCOVER LED 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, and etched Enamel.
Predicate Devices: BISCOVER LV (K043168) dated February 1, 2005.
Significant Performance Characteristics:
BISCOVER LED to BISCOVER LV
| Property | BISCOVER LV | BISCOVER LED |
|---|---|---|
| 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 LED to the predicate device BISCOVER LV clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device. BISCOVER LED 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 LED.
Page 5-1
1
Image /page/1/Picture/11 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Mr. Benjamin Lichtenwalner _. Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K051999
Trade/Device Name: Biscover LED Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: July 22, 2005 Received: July 25, 2005
Dear Mr. Lichtenwalner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaled in in 1 ( ) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } referenced above and harro to legally marketed predicate devices marketed in interstate commerce use stated in the enoroure) to regist date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nate been roetablics and 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 thereore, manter the act include requirements for annual registration, listing of devices, good economic provision, 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 rr your de how ho easy 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. Benjamin Lichtenwalner
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 (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,
Simon Purre
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):
Device Name: BISCOVER LED
Indications for Use: 「 ~· · · · · ·
$
BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
1105 1999
BISCOVER LED 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)
Ke- Mulay for MSR
Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: K051999