(34 days)
Valplast® Resin Material Pre-1976 Device, Valplast® Resin Material
Not Found
No
The summary describes a physical resin material and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
This device is a material used for fabricating dental appliances, not a therapeutic device itself. Its function is to provide a physical structure for prosthetics, rather than directly treating a medical condition.
No
The device is a material (flexible thermoplastic resin) used for fabricating dental appliances, not for diagnosing medical conditions. Its described use is fabrication, and its performance studies relate to material properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is an injection moldable, flexible thermoplastic resin, 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 use is for the fabrication of dental appliances (dentures, splints, night guards). This is a manufacturing process for a medical device that will be used in the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: It's a resin used for fabricating these appliances.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The performance studies mentioned are related to the biocompatibility and physical properties of the material itself, which are relevant for a medical device intended for use in the mouth, but not for an IVD.
N/A
Intended Use / Indications for Use
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Product codes (comma separated list FDA assigned to the subject device)
872.3760, EBI
Device Description
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection moldable, flexible thermoplastic resin designed for fabricating removable dental appliances.
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)
Physical property testing indicates that LUCITONE® FRS™ FLEXIBLE DENTAL RESIN performs equal to or better than the predicate device.
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN was evaluated as follows:
MEM Elution Test - Non-cytotoxic
Ames Mutagenicity Test - Non-mutagenic
Mucous Membrane Irritation - Non-irritant
Hamster Cheek Pouch Irritation Test, Repeated Dose - Non-irritant
Kligman Maximization Study (NaCI) - Non-sensitizer
Kligman Maximization Study (Cottonseed oil) - Non-sensitizer
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.
Valplast® Resin Material Pre-1976 Device, Valplast® Resin Material
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
510(k) SUMMARY
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 NAME & ADDRESS: (717) 845-7511 × 1717-854-2343
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
August 31, 1999 DATE PREPARED:
TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME: Denture material
Denture relining, repairing or rebasing resin CLASSIFICATION NAME: 872.3760
PREDICATE DEVICE: Valplast® Resin Material Pre-1976 Device
DEVICE DESCRIPTION: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection moldable, flexible thermoplastic resin designed for fabricating removable dental appliances.
Physical property testing indicates that LUCITONE® FRS™ FLEXIBLE DENTAL RESIN performs equal to or better than the predicate device.
INTENDED USE: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in LUCITONE® FRS™ FLEXIBLE DENTAL RESIN have been used in legally marketed devices or have been found to be safe for dental use.
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN was evaluated as follows:
MEM Elution Test Ames Mutagenicity Test Mucous Membrane Irritation Hamster Cheek Pouch Irritation Test, Repeated Dose Kligman Maximization Study (NaCI) Kligman Maximization Study (Cottonseed oil)
Non-cytotoxic Non-mutagenic Non-irritant Non-irritant Non-sensitizer Non-sensitizer
We believe that the similarity in composition of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN to the predicate device, the performance data, and the results of biocompatibility testing support the safety and effectiveness of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN for the indicated uses.
1
Substantial Equivalence Comparison:
ID of Predicate Device:
Valplast® Resin Material, manufactured and distributed by Valplast International, is the predicate device for LUCITONE® FRS™ FLEXIBLE DENTAL RESIN.
Valplast Resin Material was labeled and promoted prior to May 28, 1976. The attached literature indicates the predicate device was marketed in 1954. The FDA establishment registration information for Valplast International is also attached.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1999 ост
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
K992956 Re :
Lucitone® FRS™ Flexibel Dental Resin Trade Name: Requlatory Class: II Product Code: EBI Dated: August 31, 1999 September 2, 1999 Received:
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, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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.
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Page 2 - Mr. Lehn
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
K9929S6
Device Name: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN
Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
510(K) Number:
Over-The-Counter Use __
Susan Renner
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .
000007