(72 days)
TESCERAFLO is a dual-cure (heat/light) composite designed to be used for direct or indirect restorations. Its physical properties are similar to the predicate device and uses are identical.
Indications For Use:
- l. Esthetic restorative material for Class III, IV, and V.
- Conservative Class I and Class II not involving opposing occlusal contact for 2. direct or indirect use.
- Direct Esthetic veneer restorative for masking stains and developmental 3. anomalies.
- Pit and fissure sealant. 4.
- న్. Core buildup material to replace missing tooth structure.
- Direct cement/luting agent and dental liner. 6.
- Indirect cement for use with reinforcement materials to fabricate crowns and 7. bridges.
-
- Composite/porcelain repair material.
TESCERAFLO is a dual-cured (light/heat), moderately filled (60% by weight) low modulus flowable composite. It can be light cured by conventional means or processed in a dedicated curing device such as TESCERA ATL that employs heat and light in an oxygen-free environment. It is supplied in a syringe.
The provided text describes a 510(k) submission for a dental composite restorative material named TESCERAFLO. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, NTL-FLOW. Since this is a submission for a medical device and not an AI/ML algorithm, most of the requested information regarding AI performance criteria and studies is not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The core of the submission is to demonstrate "substantial equivalence" of TESCERAFLO to the predicate device, NTL-FLOW. The acceptance criteria are implicitly that the new device shares the same intended use, fundamental technological characteristics, and similar mechanical/physical properties as the predicate device, and is found to be non-toxic.
| Acceptance Criteria / Comparison Point | Reported Device Performance (TESCERAFLO) |
|---|---|
| Intended Use | Flowable composite; for direct or indirect restorations. |
| Chemical Composition | Dual-cured (light/heat) barium glass and silica filled (60%), dimethacrylate composite. |
| Mechanical/Physical Properties | Relatively low viscosity, syringable composite. Physical properties are similar to the predicate device. |
| Biocompatibility | Found to be non-toxic. |
The document states: "Side by side comparisons of TESCERAFLO to the predicate device NTL-FLOW clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices." It further concludes, "It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERAFLO."
Study Information (Not Applicable for AI/ML device)
The submission is for a material (composite restorative), not an AI/ML diagnostic or assistive device. Therefore, the following information is not applicable and not found in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a material science submission, not an AI/ML and human reading performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would relate to material properties, likely measured by standardized lab tests, not expert human assessment of images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For material properties, the "ground truth" would be established through laboratory testing following recognized standards for dental materials (e.g., ISO standards for composite resins) to measure properties like strength, viscosity, cure depth, etc. The document does not specify the exact type of tests or standards used, only that "significant performance characteristics" were compared.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided document focuses on demonstrating the substantial equivalence of a dental material (TESCERAFLO) to a predicate device based on its intended use, properties, and biocompatibility, rather than evaluating an AI/ML algorithm's performance.
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Page 41 of 42
JUN - 6 2003
Section 5
Contact: Stephen D. Smith
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 190 and 21 CFR par 807.92
| Trade Name: | TESCERAFLO |
|---|---|
| Common Name: | Composite Restorative Material |
| Classification name: | Material, Tooth Shade, Resin |
| Class II per 21 CFR 872.3690 |
Description of Applicant Device:
TESCERAFLO is a dual-cured (light/heat), moderately filled (60% by weight) low modulus flowable composite. It can be light cured by conventional means or processed in a dedicated curing device such as TESCERA ATL that employs heat and light in an oxygen-free environment. It is supplied in a syringe.
Intended uses of Applicant Device:
TESCERAFLO is a dual-cure (heat/light) composite designed to be used for direct or indirect restorations. Its physical properties are similar to the predicate device and uses are identical.
Predicate Devices: NTL-FLOW
| NTL-FLOW | TESCERAFLO | |
|---|---|---|
| Intended use | Flowable composite | Flowable composite |
| Chemical composite | Dual-cured (light/heat) bariumglass and silica filled (60%),dimethacrylate composite | Dual-cured (light/heat) bariumglass and silica filled (60%),dimethacrylate composite |
| Mechanical/PhysicalProperties | Relatively low viscosity,syringable composite | Relatively low viscosity,syringable composite |
Significant Performance Characteristics:
Side by side comparisons of TESCERAFLO to the predicate device NTL-FLOW clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. TESCERAFLO was tested for biocompatibility and were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERAFLO.
Stephen D. Smith Manager Regulatory Affairs Telephone: 847 534-6146 Fax: 847-534-6396
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.
Public Health Service
JUN - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy Joung, Ph.D. Director of Quality Systems Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K030951
Trade/Device Name: TESCERAFLO™ Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 24, 2003 Received: March 26, 2003
Dear Dr. Joung:
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 – Kathy Joung, Ph.D.
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 (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) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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,
Susan Russe
Susan Runner, DDS, MA Interim 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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510(k) Submission for TESCERAFLO BISCO INC., I 100 West Irving Park Road Schaumburg, IL 60193
CONFIDENTIAL
510(k) Number (if known): K030951
Device Name: TESCERAFLO
Indications For Use:
- l. Esthetic restorative material for Class III, IV, and V.
- Conservative Class I and Class II not involving opposing occlusal contact for 2. direct or indirect use.
- Direct Esthetic veneer restorative for masking stains and developmental 3. anomalies.
- Pit and fissure sealant. 4.
- న్. Core buildup material to replace missing tooth structure.
- Direct cement/luting agent and dental liner. 6.
- Indirect cement for use with reinforcement materials to fabricate crowns and 7. bridges.
-
- Composite/porcelain repair material.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Marley for MSR
(Optional Format 3-10-98)
(Division Sign-C Division of Anesthesiology, General Hospital, Int-raion Control, Dental Device
510(k) Number: K030951
Page 10 of 40
§ 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.