Removable dentures
Crown and bridge (Composite)
a. single units
b. multiple unit bridges
c. inlay bridges
d. Maryland Bridges
Provisional Crown and Bridge
a. single units
b. inlay bridges
c. multiple unit bridges
d. Maryland Bridges
Splint device reinforcement (Bruxism Appliance)
Splinting of teeth
Orthodontic Appliances

Device Description

TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are glass fiber reinforcement materials for composite and acrylic dental restorative materials. The TESCERA Fiber Bundles are loose fiber bundles. The TESCERA Fiber Mesh is a plain woven mesh. The TESCERA Fiber Cylinders are woven cylinders (sleeves) that come in several 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 is for a medical device called TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders. This device falls under the category of a Class II medical device, specifically 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin. The submission demonstrates substantial equivalence to "Ribbond-Triaxial from Ribbond, Inc, cleared under K013881".

The submission focuses primarily on claiming substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria based on pre-defined performance metrics. The data presented is purely descriptive and does not include numerical performance results, statistical analyses, or the detailed study design typically associated with a clinical or non-clinical performance study.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit, quantifiable acceptance criteria or reported device performance metrics given in a tabular format as would be expected for a detailed performance study. The submission relies on a qualitative comparison to a predicate device.

The "Technological Characteristics" section attempts to draw a parallel:

Technological Characteristics	TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders	Ribbond-Triaxial
Intended use	Reinforcing Material	Reinforcing Material
Form	Fiber bundles, woven fiber mesh and woven fiber cylinders	Woven fiber ribbon
Physical/Mechanical Properties	Increases the Flexural Strength of dental materials	Increases the Flexural Strength of dental materials

However, this table does not present acceptance criteria or specific performance values. It merely states that both the applicant device and the predicate device "increase the flexural strength of dental materials" without quantifying the increase, setting a minimum threshold, or comparing them numerically. The conclusion of substantial equivalence is drawn from "side by side comparisons" and "biocompatibility" testing, without detailing the results of these comparisons or tests.

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

This information is not provided in the document. There is no mention of a specific "test set" in the context of performance evaluation, sample sizes used for any mechanical testing (e.g., flexural strength), or the provenance (country of origin, retrospective/prospective) of such data.

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

This information is not applicable/not provided. The submission does not describe a study involving expert assessment to establish a "ground truth" for a test set. This type of assessment is typically relevant for diagnostic devices that rely on expert interpretation. This device is a material used for reinforcement.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable/not done as per the provided text. MRMC studies are typically used for diagnostic imaging devices to assess the performance of humans with and without AI assistance. This device is a dental reinforcement material.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable/not done. This device is a physical material, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For this type of material device, the "truth" would be established through physical and mechanical testing (e.g., flexural strength, biocompatibility) rather than expert consensus on diagnostic images or pathology. The document indicates that the device was "tested for biocompatibility and they were found to be non-toxic" and that it "increases the Flexural Strength of dental materials," which implies these properties were measured, but the specific methodologies, results, and thresholds are not detailed.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" mentioned or implied, as this is a physical device, not an AI/ML algorithm.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

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034024

510 (k) submission for TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders BISCO INC., 1100 West Irving Park Road Schaumburg, IL 60193

MAR 1 9 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:	December 23, 2003
2. Device Trade Name:	TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders
Common/Usual Name:	Fiber Reinforcement material
Classification/Name:	Class II per 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin

1. Predicate Device: Ribbond-Triaxial from Ribbond, Inc, cleared under K013881 dated 01/25/2002

4. Description of Application Device:

5. Intended Uses of Applicant Device:

TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are designed to be incorporated into devices as reinforcement in clinical situations where added strength is suggested or required. These situations include removable 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 Fiber Bundles, FiberMesh, and Fiber Cylinders	Ribbond-Triaxial
Intended use	Reinforcing Material	Reinforcing Material
Form	Fiber bundles, woven fiber meshand woven fiber cylinders	Woven fiber ribbon
Physical/Mechanical	Increases the Flexural Strength of	Increases the Flexural Strength of
Properties	dental materials	dental materials

6. Technological Characteristics:

Side by side comparisons of TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders to the predicate device Ribbond-Triaxial from Ribbond, Inc clearly demonstrates that the applicant devices are substantially equivalent to the legally marked devices. TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders 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 Fiber Bundles, Fiber Mesh, and Fiber Cylinders.

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Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2004

Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K034024

Trade/Device Name: TESCERA Fiber Bundles, Mash, and Fiber Cylinder Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 24, 2003 Received: January 7, 2004

Dear 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 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.

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Page 2 - Ms. Rivkowich

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 (301) 594-5618. 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,

Clus

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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Indications for Use

510(k) Number (if known): Ko 340 24

Device Name: TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders

Indications For Use:

As reinforcement for:

1. Removable dentures
1. Crown and bridge (Composite)
- a. single units
- b. multiple unit bridges
- inlay bridges C.
- Maryland Bridges ರ.
1. Provisional Crown and Bridge
- a. single units
- b. inlay bridges
- c. multiple unit bridges
- d. Maryland Bridges
1. Splint device reinforcement (Bruxism Appliance)
1. Splinting of teeth
1. Orthodontic Appliances

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)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

AND/OR

Page 1 of 1

510(k) Number:__

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.