(41 days)
AELITEFIL
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a dental composite, with no mention of AI or ML technologies.
No.
This device is a dental restorative material used to replace missing tooth structure and for aesthetic veneers, not for treating or diagnosing a disease or condition.
No.
The device is a restorative material (composite) used for dental fillings, veneers, and core build-ups, not for diagnosing conditions.
No
The device description clearly states it is a "highly filled (74% w/w), light-cured radiopaque hybrid composite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are all related to direct dental restorations and repairs within the mouth (in vivo). IVDs are used to examine specimens taken from the human body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a dental composite material used for filling cavities and repairing teeth. This is a therapeutic device, not a diagnostic one.
- Anatomical Site: The anatomical site is "Tooth structure," which is part of the living body.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the material (tensile strength, flexural modulus) and biocompatibility, which are relevant for a dental restorative material, not an IVD.
The device is clearly a dental restorative material intended for use directly on the patient's teeth.
N/A
Intended Use / Indications for Use
RENEW is indicated for: Class I, III, IV, V and VI restorations, direct aesthetic veneers for masking stains and developmental anomalies, core build ups to replace missing tooth structure and composite/ porcelain repairs.
Product codes
EBF
Device Description
RENEW, universal hybrid composite, is a highly filled (74% w/w), light-cured radiopaque hybrid composite. Its physical/mechanical properties are similar to the predicate device and uses are identical. Like the predicate device, RENEW is barium glass and silica filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light activated initiators. Both devices are designed to be used with high quality dentin/ enamel adhesive systems.
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)
Non-clinical tests were performed similar to those specified in ISO 4049 and American Dental Association §27 for dental resin-based filling materials. Diametral tensile testing (DTS) was used to characterize tensile strength, and flexural modulus test addressed strength in three-point loading. DTS values were 45 MPa for the predicate (AELITEFIL) and 50 MPa for RENEW. Biocompatibility, specifically cytotoxicity, of RENEW was tested in conformance with good laboratory practice and EN 45001 (ISO 10993-5) 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 45 and 50 MPa for AELITEFIL and RENEW 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.
AELITEFIL
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
SEP 15 1998
510(k) Submission for RENEW™M BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 22 of 25
As Required by 21
APPLICANT DEVICE Trade Name: RENEW™M Common Name: Composite Restorative Material Classification Name: Tooth Shade Resin Material, Class II, 21 CFR 872.3690
LEGALLY MARKETED PREDICATE DEVICE: AELITEFIL™
PREDICATE DEVICE AELITEFIL
AELITEFIL, universal hybrid composite, is a highly filled (75% by wt.), light cured hybrid composite restorative material is radiopaque and indicated for all types of cavity preparations. The hybrid blend of ultra fine primary filler (averaging 0.7 µm with tightly controlled distribution) and submicron silica results in superior optical qualities and physical/mechanical properties. The material bonds micromechanically and chemically to dental primers/bonding resin adhesives through co-polymerization of the former's air inhibited layer. AELITEFIL is designed to be marketed as a stand alone product.
DESCRIPTION OF APPLICANT DEVICE RENEW
RENEW, universal hybrid composite, is a highly filled (74% w/w), light-cured radiopaque hybrid composite. Its physical/mechanical properties are similar to the predicate device and uses are identical. Like the predicate device, RENEW is barium glass and silica filled dimethacrylate composite. It hardens by light cure polymerization mechanism employing light activated initiators. Both devices are designed to be used with high quality dentin/ enamel adhesive systems.
INTENDED USES OF APPLICANT DEVICE RENEW
RENEW is indicated for: Class I, III, IV, V and VI restorations, direct aesthetic veneers for masking stains and developmental anomalies, core build ups to replace missing tooth structure and composite/ porcelain repairs.
1
510(k) Submission for RENEW™M BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 23 of 25
510(k) SUMMARY (cont.)
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
AELITEFIL and RENEW are very similar with regard to chemical composition and selected physical/mechanical properties. Significantly, AELITEFIL and RENEW have been designed to achieve 'Non-Sticky' handling before cured as well as high polishability and strength when cured. These properties are desired of restoratives to be indicated for all types of cavity preparations. The hybrid blend of ultra fine primary filler (averaging 0.7 µm with tightly controlled distribution) barium glass, and silica results in high strength and polishability of cured AELITEFIL and RENEW. The Bis-GMA and UDMA monomers of AELITEFIL are balanced to achieve 'Non-Sticky' handling. RENEW is based on the the ethoxylated version of Bis-GMA resulting in reduction of 'stickiness' even more.
The chemical compositions of AELITEFIL and RENEW are quite similar. Both are barium glass and silled methacrylate hybrid composites. Both are light cured, and radiopaque for easy radiographic identification and evaluation.
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association $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 45 and 50 MPa for AELITEFIL and RENEW respectively.
Biocompatability of RENEW, Cytotoxicity, was tested in conformance with good laboratory practice and EN 45001 (ISO 10993-5) by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.
Side by side comparisons of RENEW to the predicate device provided in this submission clearly demonstrated that the applicant device, RENEW, is substantially equivalent to the legally marketed predicate device, AELITEFIL, in terms of effectiveness or suitability to the intended uses.
K. Joung
Dr. Joung, Ph.D.
Kathy Jour QA/QC Manager 1-800-BIS-DENT or 847-534-6106 Fax: 847-891-6865 August 3, 1998
2
510(k) Submission for RENEW™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 24 of 25
REFERENCES
- Craig, R. G. (ed), Restorative Dental Materials, eighth edition, C. V. 1. Mosby Co., St. Louis, 1989, p 277.
-
- International Standards Organization, ISO 4049:1988/Cor. 1:1992 (E), Resin Based Filling Materials, 1992.
- Bisco, Inc. Quality Control Testing Procedure, QC-0004, 1987. 3.
- ibid. QC-003, 1998 4.
- ibid. QC-006, 1997 5.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged around the top and left side of the profile graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Kathy Jounq, Ph.D. QA/QC Manager BISCO. Incorporated 1100 W. Irving Park Road Schaumburg, Illinois 60193
K982729 Re : RENEW™ Trade Name: Requlatory Class: II Product Code: EBF Dated: August 3, 1998 Received: Auqust 5, 1998
Dear Dr. Joung:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
4
Page 2 - Dr. Joung
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Submission for RENEW™ BISCO, INC., 1100 W. Irving Park Road Schaumburg, IL 60193
SH 10 of 25
INDICATIONS for USE
510(k) Number (if known):______ K982729
Device Name: _RENEW™
Indications for Use:
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- Class I, II, III, IV, V and VI restorations.
-
- Direct aesthetic veneers for masking stains and developmental anomalies.
-
- Core build ups to replace missing tooth structure.
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- Composite and porcelain repairs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982729
OR