(112 days)
Not Found
No
The summary describes a dental resin and powder system for opaquing and sculpting, with no mention of AI or ML capabilities.
No
The device is described as a resin used as a pre-wetting agent for composites and to opaque/mask metal substrates in dental restorations, which are functional aspects of dental work rather than therapeutic treatments.
No
The device is described as a pre-wetting agent for composites and a material used to opaque/mask metal substrates and other materials in dental restorations. Its function is to facilitate and enhance dental restorative procedures, not to diagnose conditions.
No
The device description clearly indicates it is a physical material (resin and powder) used in dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental restorations, specifically as a pre-wetting agent for composites and for opaquing/masking metal substrates in dental work. This is a direct application within the mouth for restorative purposes.
- Device Description: The description reinforces its use in dental procedures, focusing on its properties as a resin and composite system for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the mouth as part of a dental restoration process.
N/A
Intended Use / Indications for Use
TESCERA Opaquer/Sculpting Resin is intended for wetting instruments to aid in the placement and shaping of composites. TESCERA Opaquer/Sculpting Resin mixed with TESCERA Opaquer Powder is a dual-cured (light and/or heat cured) tooth colored opaquing/masking composite system intended for masking the materials used in dental prostheses.
TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.
When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.
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 TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder.
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
FEB - 1 2005
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: October 8, 2004
| Trade Name: | TESCERA Opaquer/Sculpting Resin and Opaquer Powder |
|---|---|
| Common Name: | Dental Opaquing/Masking Composite and Wetting Resin |
| Classification/Name: | Tooth Shade Resin Material |
| Class II per 21 CFR 872.3690 |
Description of Applicant Device:
TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.
Intended uses of Applicant Device:
TESCERA Opaquer/Sculpting Resin is intended for wetting instruments to aid in the placement and shaping of composites. TESCERA Opaquer/Sculpting Resin mixed with TESCERA Opaquer Powder is a dual-cured (light and/or heat cured) tooth colored opaquing/masking composite system intended for masking the materials used in dental prostheses.
TESCERA Opaquer Powder and Opaquer/Sculpting Resin are optimized for use with the TESCERA ATL (Aqua-Thermal-Light) system.
Predicate Devices:
D/C OPAQUER (a.k.a. Opaquer Resin), cleared under Bisco Porcelain Repair Kit (K874557) dated January 28, 1988.
MODELING RESIN (a.k.a. Sculpting Resin), cleared under Sculpting Resin (K030585) dated May 2, 2003.
1
Section 5 510 (k) SUMMARY (continued)
Significant Performance Characteristics:
D/C OPAQUER to TESCERA Opaquer/Sculpting Resin and Opaquer Powder
| Property | D/C OPAQUER | TESCERA
Opaquer/Sculpting Resin
and Opaquer Powder |
|---------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Intended use | Substrate Opaquer/Masker | Substrate Opaquer/Masker |
| Chemical composition | Dual cure (light and self), filled, dimethacrylate composite | Dual cure (heat and light), filled, dimethacrylate composite |
| Mechanical /physical properties | Low viscosity, tooth colored, paste-to-paste opaquer/masker | Low viscosity, tooth colored, powder-to-resin opaquer/masker |
MODELING RESIN to TESCERA Opaquer/Sculpting Resin
| Property | MODELING RESIN | TESCERA |
|---|---|---|
| Opaquer/Sculpting Resin | ||
| Intended use | Wetting of composite instruments | Wetting of composite instruments |
| Chemical composition | Light cured, filled, dimethacrylate composite | Dual cured (heat/light), unfilled, dimethacrylate resin |
| Mechanical /physical properties | Slightly viscous, straw colored, instrument wetting agent | Low viscosity, light yellow, instrument wetting agent |
Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder.
Page 5-2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The text is in all capital letters and is smaller than the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 1 2005
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco. Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
Re: K042804
Trade/Device Name: TESCERA Opaquer/Sculpting Resin and Opaquer Powder Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 22, 2004 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 the Federal 9 000g, Drag, Drag, 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.
3
Page 2 – Mr. 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 moun that 1 Drima made 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 and listing (21 et read on), equality 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) rins leter notification. The FDA finding of substantial equivalence of your device to a premainer nourseans and in a classification for your device and thus, permits vour 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" (21CFR 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,
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
4
Ko42804 510 (k) Number (if known):
TESCERA Opaquer/Sculpting Resin and Opaquer Powder Device Name:
Indications for Use:
TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.
When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Usc (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 Runge
(Division Sign-Off)
Division of Anesthesiology
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(K) Number K042804