(72 days)
NTL-FLOW
Not Found
No
The document describes a dental composite material and its intended uses, with no mention of AI or ML technology.
No
The device is a restorative material for dental use, not a therapeutic device. Its purpose is to physically restore tooth structure or act as a sealant/cement, rather than to treat a disease or medical condition.
No
The device, TESCERAFLO, is described as a restorative and cementing material for dental applications, not as a tool for diagnosing medical conditions. Its uses are for treatment, repair, and restoration of teeth.
No
The device is a composite material supplied in a syringe, clearly indicating it is a physical substance and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of TESCERAFLO is for direct and indirect dental restorations, core buildup, cementation, and repair. These are all procedures performed on the patient's tooth structure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Description: The description details a composite material used for filling and restoring teeth, not for analyzing biological samples.
- Anatomical Site: The anatomical site is the tooth, which is the site of application, not the source of a diagnostic specimen.
The information provided clearly indicates that TESCERAFLO is a dental restorative material used directly in the mouth, not a device for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
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.
- 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.
Product codes
EBF
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NTL-FLOW
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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) barium | |
| glass and silica filled (60%), | ||
| dimethacrylate composite | Dual-cured (light/heat) barium | |
| glass and silica filled (60%), | ||
| dimethacrylate composite | ||
| Mechanical/Physical | ||
| Properties | 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
1
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.
2
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
3
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