(73 days)
Not Found
No
The device description and intended use focus on material properties and structural reinforcement, with no mention of AI/ML terms or functionalities.
No
The device is a reinforcement material for dental composites and acrylics, primarily used for structural support in dental restorations and appliances, not for treating diseases or medical conditions.
No
The device description and intended use indicate it is a reinforcement material for dental restorations and appliances, not a tool for diagnosing medical conditions.
No
The device description clearly states that the device is a physical material (epoxy resin impregnated quartz fibers) used for reinforcement, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this product is a reinforcement material for dental restorations (crowns, bridges, splints, orthodontic appliances). It is used in the mouth, not to test samples taken from the body.
- The description focuses on the material properties and intended applications within dentistry. There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
Therefore, this device falls under the category of a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
TESCERA U-Bar and Barrels are designed to be incorporated into devices as reinforcement in clinical situations where added strength is suggested or required. These situations include rcrnovable prosthetic devices such as dentures, splints, and orthodontic appliances as well as fixed prosthetic devices such as inlays, crowns, bridges, and splints. The intended uses of the applicant device are the same as the predicate device.
Indications For Use:
As reinforcement for:
-
- Crown and Bridge (Composite)
- a. Multiple unit bridges
- b. Inlay Bridges
-
- Provisional Crown and Bridge
- a. Multiple unit bridge
- b. Inlay bridges
-
- Splint Device reinforcement (Bruxism Appliance)
-
- Splinting of teeth
-
- Orthodontic Appliances
Product codes
EBI
Device Description
TESCERA U-Bar and Barrel Fiber Reinforccment Materials are epoxy resin impregnated quartz fibers for reinforcing dental composite and acrylic restorative materials. The TESCERA U-Bar comes in a U Bar shape, and the TESCERA Barrels come in rod shapes with different size diameters They are designed to be used with the TESCERA indirect composite system but should be effective with other indirect and direct systems
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)
TESCERA U-Bar and Barrels were tested for biocompatibility and they was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA U-Bar and Barrels.
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
510 (k) submission for TESCERA U-Bar and Barrels BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193
CONFIDENTIAL
JAN 1 5 2004
Section 5
Page 5-1
510 (k) SUMMARY
| 1. Applicant: | Bisco, Inc
1100 West Irving Park Road
Schaumburg, IL 60193 |
|-----------------------|-----------------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner
Ph. 847-534-6146
Fax 847-534-6111 |
| Prepared Date: | October 31, 2003 |
| 2. Device Trade Name: | TESCERA U-Bar and Barrels |
| Common/Usual Name: | Fiber reinforcement material |
| Classification/Name: | Class II per 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin |
-
- Predicate Device: everStick from Stick Tech Ltd, cleared under K011788 dated 11/5/2001
4. Description of Application Device:
TESCERA U-Bar and Barrel Fiber Reinforccment Materials are epoxy resin impregnated quartz fibers for reinforcing dental composite and acrylic restorative materials. The TESCERA U-Bar comes in a U Bar shape, and the TESCERA Barrels come in rod shapes with different size diameters They are designed to be used with the TESCERA indirect composite system but should be effective with other indirect and direct systems
5. Intended Uses of Applicant Device:
TESCERA U-Bar and Barrels are designed to be incorporated into devices as reinforcement in clinical situations where added strength is suggested or required. These situations include rcrnovable prosthetic devices such as dentures, splints, and orthodontic appliances as well as fixed prosthetic devices such as inlays, crowns, bridges, and splints. The intended uses of the applicant device are the same as the predicate device.
| Technological
| Characteristics | TESCERA U-Bar and Barrels | everStick |
|---|---|---|
| Intended use | Reinforcement Material | Reinforcement Material |
| Chemical Composition | Fibers imbedded in resin | Fibers imbedded in resin |
| Physical/Mechanical | ||
| Properties | Increases the strength of dental | |
| materials | Increases the strength of dental | |
| materials |
6. Technological Characteristics:
Side by side comparisons of TESCERA U-Bar and Barrels to the predicate device everStick from Stick Tcch, Inc clearly demonstrates that the applicant devices are substantially equivalent to the legally marked devices. TESCERA U-Bar and Barrels were tested for biocompatibility and they was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA U-Bar and Barrels.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K033472
Trade/Device Name: Tescera U-Bar and Barrels Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: October 31, 2003 Received: November 3, 2003
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 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 (1112 ), it inch 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. 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 mount that I Dr may Federal statutes and regulations administered by other Federal agencies. or mo receir any a 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 instille (- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 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) Find reter 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you acontact the Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Oil
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
33472
Indications for Use
510(k) Number (if known): K033472
Device Name: TESCERA U-Bar and Barrels
Indications For Use:
As reinforcement for:
-
- Crown and Bridge (Composite)
- a. Multiple unit bridges
- b. Inlay Bridges
-
- Provisional Crown and Bridge
- a. Multiple unit bridge
- b. Inlay bridges
-
- Splint Device reinforcement (Bruxism Appliance)
-
- Splinting of teeth
-
- Orthodontic Appliances
AND/OR Prescription Use ✓ (Part 21 CFR 801 Subpart D)
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)
Suzer Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control Dental Devices
Page 1 of 1
510(k) Number: K033472