(40 days)
Not Found
No
The device description and intended use are for a dental restorative material, and there is no mention of AI or ML in the provided text.
No
This device is a dental restorative material used for filling defects and restoring teeth, which is not considered a therapeutic device in the medical device context. It primarily functions as a restorative or prosthetic material.
No
The device description and intended use indicate that DYRACT® FLOW RESTORATIVE is a dental composite material used for filling and repairing dental defects, and not for diagnosing medical conditions.
No
The device description clearly states it is a "dental composite restorative material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the direct restoration and repair of teeth. This involves physically interacting with the tooth structure and filling defects, which is a therapeutic or restorative function, not a diagnostic one.
- Device Description: The description clearly states it is a "dental composite restorative material" and a "low viscosity, esthetic material for use as a composite restorative." This further reinforces its role in restoring tooth structure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition. IVDs are designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening.
Therefore, DYRACT® FLOW RESTORATIVE is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; Liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III, V restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material.
DYRACT® FLOW RESTORATIVE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions.
The physical properties of DYRACT® FLOW RESTORATIVE meet ISO Standard 4049.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
AUG 18 1998
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax 17171 854-2343
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
JUL 0 8 1998 DATE PREPARED:
TRADE OR PROPRIETARY NAME:DYRACT® FLOW RESTORATIVE
COMMON OR USUAL NAME: Dental restorative material
| CLASSIFICATION NAME: | Tooth shade resin material | 872.3690 |
|---|---|---|
| PREDICATE DEVICE: | Dyract® AP™ Restorative | |
| Aeliteflo Composite | K973235 | |
| K955292 |
DEVICE DESCRIPTION: DYRACT® FLOW RESTORATIVE is a one-component, moderately filled, visible light cured dental composite restorative material.
DYRACT® FLOW RESTORATIVE is a low viscosity, esthetic material for use as a composite restorative. It is a moderately filled, radiopaque, fluoride-releasing composite, primarily designed for restoration of shallow defects such as incipient Class V lesions.
The physical properties of DYRACT® FLOW RESTORATIVE meet ISO Standard 4049. 117 2017
INTENDED USE: DYRACT® FLOW RESTORATIVE is used for: Filling of defects and undercuts in crowns, inlays; Liner under direct restorative materials and under inlay restorations-Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III, V restorative Class I restorations; and Margin correction/adjustment of composite crowns for indirect laboratory use.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in DYRACT® FLOW RESTORATIVE have either been used in predicate dental devices or have been found safe for dental use.
We believe that the prior use of the components of DYRACT® FLOW RESTORATIVE in legally marketed predicate devices, the performance data, and the biocompatibility data provided support the safety and effectiveness of DYRACT® FLOW RESTORATIVE for the indicated uses.
000015
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K982395 Trade Name: Dyract® Flow Restorative Requlatory Class: II Product Code: EBF Dated: July 8, 1998 Received: July 9, 1998
Dear Mr. Lehn:
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, labelinq, 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. ਚੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Lehn
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" (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,
S. Putman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Image /page/3/Picture/4 description: The image shows a sequence of handwritten characters. The characters are 'K982395'. The characters are written in a simple, clear style, and they are all connected by a line underneath.
Device Name:
DYRACT® FLOW RESTORATIVE
- Filling of defects and undercuts in crowns, inlays and onlays; ●
- Liner under direct restorative materials and under inlay restorations--Class II box liner;
- . Tunnel preparations;
- Pit and fissure sealants; ●
- Amalgam margin repair; Improving margins of acrylic temporaries;
- . Small class IV repairs;
- . Intraoral porcelain repair;
- . Cementing porcelain veneers, crowns, inlays/onlays;
- Refacing acrylic temporaries;
- . Blockouts:
- . Covering incisal edge stains;
- Repair of small enamel defects; .
- . Provisional occlusal changes;
- Class III, V restorations; ●
- . Conservative Class I restorations;
- . Margin correction/adjustment of composite crowns for indirect laboratory use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Surya Raoor
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device KK 510(k) Number
000007