TESCERA U-Bar and Barrel Fiber Reinforcement 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

AI/ML Overview

This 510(k) submission for TESCERA U-Bar and Barrels does not describe specific acceptance criteria beyond "substantially equivalent" to its predicate device, everStick. The study that proves the device meets this "acceptance criteria" is a side-by-side comparison of the applicant device to the predicate device, demonstrating overall substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (everStick)	"Side by side comparisons... clearly demonstrates that the applicant devices are substantially equivalent to the legally marked devices." Additionally, "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."
Biocompatibility	Found to be non-toxic.

Note: The document does not specify quantitative performance metrics or specific thresholds for "substantial equivalence" beyond the general statements provided. This is typical for 510(k) submissions relying on substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Side by side comparisons" and "tested for biocompatibility."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish ground truth for any test set or any qualifications of such experts. The evaluation appears to be based on direct comparison to the predicate device and biocompatibility testing.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a dental material (fiber reinforcement material), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or expected.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a dental material, not an algorithm or software device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not directly applicable to this type of dental material. The "truth" for this device's performance is established by demonstrating its material properties (biocompatibility) and functional equivalence (reinforcement capabilities) to a legally marketed predicate device. The document implies:

Predicate Device Performance as a benchmark: The existing standard of performance set by the everStick device serves as the implicit "ground truth" for what constitutes acceptable "reinforcement material" performance.
Biocompatibility testing results: The "non-toxic" finding from biocompatibility tests represents a measurable "ground truth" for safety.

8. The Sample Size for the Training Set

The document does not mention a "training set." This is a material-based device submission, not a machine learning or AI algorithm.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set mentioned, there is no ground truth established for it.

Summary

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K033472

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, Inc1100 West Irving Park RoadSchaumburg, IL 60193
Contact Person:	Benjamin LichtenwalnerPh. 847-534-6146Fax 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

1. 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.

TechnologicalCharacteristics	TESCERA U-Bar and Barrels	everStick
Intended use	Reinforcement Material	Reinforcement Material
Chemical Composition	Fibers imbedded in resin	Fibers imbedded in resin
Physical/MechanicalProperties	Increases the strength of dentalmaterials	Increases the strength of dentalmaterials

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.

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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.

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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

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33472

Indications for Use

510(k) Number (if known): K033472

Device Name: TESCERA U-Bar and Barrels

Indications For Use:

As reinforcement for:

1. Crown and Bridge (Composite)
- a. Multiple unit bridges
- b. Inlay Bridges
1. Provisional Crown and Bridge
- a. Multiple unit bridge
- b. Inlay bridges
1. Splint Device reinforcement (Bruxism Appliance)
1. Splinting of teeth
1. 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

Regulation Number and Section

§ 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.