(34 days)
Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection moldable, flexible thermoplastic resin designed for fabricating removable dental appliances.
The subject device is LUCITONE® FRS™ FLEXIBLE DENTAL RESIN, a dental material. The supporting document is a 510(k) summary (K992956) for this device.
Acceptance Criteria and Device Performance Study for K992956
This 510(k) summary provides information on the substantial equivalence of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN to a predicate device, rather than detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of AI/software performance. The device is a dental material, not an AI or software-driven medical device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission.
The "acceptance criteria" for a dental material are typically defined by a set of physical, chemical, and biocompatibility properties that demonstrate it is safe and effective for its intended use and performs at least as well as a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Property | Predicate Device Information (Implicit Standard: "equal to or better than") | Reported Device Performance (LUCITONE® FRS™ FLEXIBLE DENTAL RESIN) |
|---|---|---|---|
| Physical Properties | (Not specified in detail, but implied as critical for dental resins) | Performance of Valplast® Resin Material (Pre-1976 device) | "performs equal to or better than the predicate device." |
| Biocompatibility | MEM Elution Test | Non-cytotoxic (expected for safe dental materials) | Non-cytotoxic |
| Biocompatibility | Ames Mutagenicity Test | Non-mutagenic (expected for safe dental materials) | Non-mutagenic |
| Biocompatibility | Mucous Membrane Irritation Test | Non-irritant (expected for safe dental materials) | Non-irritant |
| Biocompatibility | Hamster Cheek Pouch Irritation Test, Repeated Dose | Non-irritant (expected for safe dental materials) | Non-irritant |
| Biocompatibility | Kligman Maximization Study (NaCl) | Non-sensitizer (expected for safe dental materials) | Non-sensitizer |
| Biocompatibility | Kligman Maximization Study (Cottonseed oil) | Non-sensitizer (expected for safe dental materials) | Non-sensitizer |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. For physical property testing and biocompatibility, sample sizes are typically determined by relevant ISO or ASTM standards for materials testing.
- Data Provenance: Not specified, but generally refers to laboratory testing results conducted by or for DENTSPLY International. Given the nature of materials testing, it would be laboratory-controlled (neither prospective nor retrospective in the clinical sense).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of device performance for a dental material, is established through standardized laboratory testing and accepted chemical/biological assays, not by expert interpretation in the way it is for imaging or diagnostic AI. The tests themselves are the "ground truth."
4. Adjudication method for the test set
- Not applicable. See point 3. Testing results are objective measurements from laboratory instruments and assays.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a dental material, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental material.
7. The type of ground truth used
- Laboratory Testing Results: The ground truth for this device is based on the objective results of standardized physical property tests and biocompatibility assays (e.g., cytotoxicity, mutagenicity, irritation, sensitization).
- Predicate Device Performance: Implicitly, the performance and safety profile of the legally marketed predicate device (Valplast® Resin Material) serves as a benchmark for substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a dental material, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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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.
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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
§ 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.