K Number
K974483
Device Name
NTL-FLOW
Manufacturer
Date Cleared
1998-02-09

(75 days)

Product Code
Regulation Number
872.3690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NTL-FLOW is indicated for: anterior esthetic restorative material for Class III, IV, and V as well as conservative Class I restorations not involving opposing occlusal wear for direct or indirect use. Direct Esthetic veneer restorative for masking stains and developmental anomalies. Pit and fissure sealant. core build-up material to replace missing tooth structure. Dental cement/luting agent and dental liner. Composite/porcelain repair material.
Device Description
NTL-FLOW is a dual-cure (light or heat and light) moderately filled (60%), radiopaque low modulus flowable composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, NTL-FLOW is a glass frit filled dimethacrylate composite. It hardens by a light or heat and light cure polymerization mechanism employing a light initiator, and a tertiary amine activator and peroxide initiator. Both devices are designed to be used with high quality dentin / enamel adhesive systems. The material can be used in a conventional fashion or it can be processed in a dedicated curing device that employs light, and a substantially oxygen free atmosphere created by flushing the device with an inert gas such as nitrogen. The heat is supplied by the lamp providing the light. The comparative low modulus facilitates the use of the material as a first increment liner that is intended to bond to the dental adhesive as well as the next increment composite.
More Information

Not Found

No
The device description focuses on the material composition and curing mechanism of a dental composite, with no mention of AI or ML capabilities. The performance studies are based on standard material property tests.

No.
The device is a dental restorative material used to replace missing tooth structure, repair composites/porcelains, or for pit and fissure sealing, rather than to treat or cure a disease or condition.

No

The device is a restorative dental material used for repairing and restoring teeth, not for diagnosing medical conditions.

No

The device description clearly indicates NTL-FLOW is a physical material (flowable composite) used for dental restorations, not a software program.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the material as a restorative material, sealant, core build-up, cement, liner, and repair material for teeth. These are all applications directly within the patient's mouth for treatment and restoration.
  • Device Description: The description details the composition and properties of a dental composite material used for filling cavities and other dental procedures.
  • Anatomical Site: The anatomical site is "Teeth," which is a part of the human body.
  • Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the body.

IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is applied directly to the patient's teeth for therapeutic and restorative purposes.

N/A

Intended Use / Indications for Use

NTL-FLOW is indicated for: anterior esthetic restorative material for Class III and IV as well as conservative Class I restorations not involving opposing occlusal wear, direct esthetic veneer restorative for masking stains and developmental anomalies, pit and fissure sealant, core buildup material to replace missing tooth structure, dental cement/luting agent, composite repair, and a liner/base material.

  1. Anterior esthetic restorative material for Class III, IV, and V as well as conservative Class I restorations not involving opposing occlusal wear for direct or indirect use.
  2. Direct Esthetic veneer restorative for masking stains and developmental anomalies.
  3. Pit and fissure sealant.
  4. Core build-up material to replace missing tooth structure.
  5. Dental cement/luting agent and dental liner.
  6. Composite/porcelain repair material.

Product codes (comma separated list FDA assigned to the subject device)

33EYP

Device Description

NTL-FLOW is a dual-cure (light or heat and light) moderately filled (60%), radiopaque low modulus flowable composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, NTL-FLOW is a glass frit filled dimethacrylate composite. It hardens by a light or heat and light cure polymerization mechanism employing a light initiator, and a tertiary amine activator and peroxide initiator. Both devices are designed to be used with high quality dentin / enamel adhesive systems. The material can be used in a conventional fashion or it can be processed in a dedicated curing device that employs light, and a substantially oxygen free atmosphere created by flushing the device with an inert gas such as nitrogen. The heat is supplied by the lamp providing the light. The comparative low modulus facilitates the use of the material as a first increment liner that is intended to bond to the dental adhesive as well as the next increment composite.

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)

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association Specification #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively. Cytotoxicity of NTL-FLOW was performed by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K945604

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 K974483 510(k) submission for NTL-FLOW

510(k) SUMMARY

As Required by the Safe Medical Devices Act of 1990

IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

PREDICATE DEVICE AELITEFLO™

AELITEFLO is a low viscosity, light-cure hybrid composite restorative material. It is a moderately filled (59% w/w), radiopague, flowable composite designed primarily for restoration of shallow defects such as incipient Class V lesions. It functions well as an anterior esthetic material to reshape and esthetically restore stained or otherwise developmentally compromised anterior teeth. AELITEFLO bonds micromechanically and chemically to dental primers/bonding resin adhesives through co-polymerization of the former's air inhibited laver. AELITEFLO is designed to be marketed as a stand alone product but can be made available in kit form including semi-gel etchant [K945604] and COMPOSITE PRIMER.

DESCRIPTION OF APPLICANT DEVICE

NTL-FLOW

NTL-FLOW is a dual-cure (light or heat and light) moderately filled (60%), radiopaque low modulus flowable composite. Its physical properties are similar to the predicate device and uses are identical. Like the predicate device, NTL-FLOW is a glass frit filled dimethacrylate composite. It hardens by a light or heat and light cure polymerization mechanism employing a light initiator, and a tertiary amine activator and peroxide initiator. Both devices are designed to be used with high quality dentin / enamel adhesive systems. The material can be used in a conventional fashion or it can be processed in a dedicated curing device that employs light, and a substantially oxygen free atmosphere created by flushing the device with an inert gas such as nitrogen. The heat is supplied by the lamp providing the light. The comparative low modulus facilitates the use of the material as a first increment liner that is intended to bond to the dental adhesive as well as the next increment composite.

INTENDED USES OF APPLICANT DEVICE NTL-FLOW

NTL-FLOW is indicated for: anterior esthetic restorative material for Class III and IV as well as conservative Class I restorations not involving opposing occlusal wear, direct esthetic veneer restorative for masking stains and developmental anomalies, pit and fissure sealant, core buildup material to replace missing tooth structure, dental cement/luting agent, composite repair, and a liner/base material.

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1

SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS

AELITEFLO and Bisco NTL-FLOW are very similar with regard to chemical composition and selected physical/mechanical properties. Significantly, AELITEFLO and NTL-FLOW, following curing, have been designed to be more flexible than conventional dental composites. Also, the flow characteristics or so-called syringability of these materials are superior to more highly filled materials. The viscoelastic properties of conventional microfil composites are dependent on the interaction of submicron silica fillers and the design resin. Because of the enormous surface area of submicron silica, a much smaller amount of filler can be incorporated into a composite compared with a larger filler such as 0.7 µm barium glass as used in NTL-FLOW and AELITEFLO. The flowability of NTL-FLOW, therefore, is achieved by a careful balance of resin viscosities and filler loading. Submicron filler is also used in NTL-FLOW but to a much lesser extent than conventional microfil composites.

The flexibility of cured NTL-FLOW is achieved by an imaginative balance of polymerizable resins. These resins in concert with the fillers noted above achieve the properties described in this application, namely high service strength, flexibility, and ease of manipulation or syringability. Relative reduction of filler content typically reduces surface hardness of composites and that is evident with NTL-FLOW which has approximately 10% lower Barcol hardness than conventional composites.

The chemical composition of NTL-FLOW and AELITEFLO are quite similar. Both are silica and /or glass filled dimethacrylate light-cure composites. NTL-FLOW is based on the ethoxylated version of Bis-GMA whereas AELITEFLO is primarily a Bis-GMA triethyleneglycol dimethacrylate combination.

The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association Specification #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively. Cytotoxicity of NTL-FLOW was performed by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.

Comparison of NTL-FLOW to the predicate device shows both are very similar with the major difference being the methods of final cure of the product. The proposed new product cures using visible light or heat (125°C) and light. The predicate device can cures using visible light exclusively.

James L. Sandvik

James L. Sandrik, Ph.D. BISCO, Inc. Schaumburg, IL 60193 November 25, 1997

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1998 FEB

James L. Sandrik, Ph.D. Director of Technical Affairs Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193

K974483 Re : NTL-FLOWTM Trade Name: Requlatory Class: II Product Code: 33F Dated: November 25, 1997 Received: November 26, 1997

Dear Dr. Dandrik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with ....... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

3

Page 2 - Dr. Sandrik

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timot A. Ulatowski Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BISCO, INC., 1100 W. Irving Park Road, Schaumburg, IL 60193 510(k) submission for NTL-FLOW

INDICATIONS for USE

510(k) Number (if known):K974483
Device Name:NTL-FLOW
Indications for Use:Anterior esthetic restorative material for Class III, IV, and V as well as conservative Class I restorations not involving opposing occlusal wear for direct or indirect use.
  • Direct Esthetic veneer restorative for masking stains and developmental anomalies. 2.
  • ૩. Pit and fissure sealant.
  • core build-up material to replace missing tooth structure. 4.
    1. Dental cement/luting agent and dental liner.
    1. Composite/porcelain repair material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRL, Office of Device Evaluation (ODE)
Infection Control,
Hospital DevicesK974483
Prescription Use X
(Per 21 CFR 801.109)OR
Over-The-Counter Use No
(Optional Format 1-2-96)