(50 days)
Not Found
No
The summary describes a dental relining material and its biocompatibility testing, with no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is a lining material for dentures, not a device that provides therapy for a disease or condition. Its purpose is to repair or rebase dentures.
No.
The intended use is to serve as a lining material for dentures, which is a treatment or restorative function, not a diagnostic one.
No
The device description is not found, but the intended use and performance studies clearly indicate a material (Mucopren) used for relining dentures, which is a physical product, 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 "as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures." This describes a material used in the mouth to modify a dental prosthesis, not a test performed on a sample taken from the body to diagnose a condition.
- 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.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a material used in the fabrication or modification of a dental device (denture), which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Not Found
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)
Test data for biocompatibility of Mucopren was supplied in accordance with ODE General Program Memorandum #G95-1, using International Standard ISO 10993 for surface devices having prolonged contact with mucosal membrane. Less formal biocompatibility tests from Europe also were made. These data are supplied in Appendix III.
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.
K964040, K953589, K963736, K954810
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
XI. SAFE MEDICAL DEVICES ACT OF 1990 SUM OF SAFETY AND EFFECTIVENESS. Sept. 17, 1998. [Separate Pages]
510(1-15
I. * Submitter: Donald LeRoy, Roydent Dental Products, 1010 West Hamlin Rd., Rochester Hills. MI. 48309. Phone: 248-652-2500.
II. Classification Names and numbers: Denture relining, repairing, rebasing resin, 76EBI
III. Common/Usual Name: Relining, rebasing resin.
IV. Proprietary Names: Mucoderm™ soft reliner system
V. Establishment Registration Number: 2523439
VI. Classification: Denture relining, rebasing resins were classified by the Dental Devices Panel into Class II. They are described under CFR 872.3760.
VII. Substantial Equivalence: Roydent™ is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K964040, Trubyte Soft Reline System, Dentsply Int'l, K953589, Tokuyama Soft Relining, Tokutyama America; K963736, Soft Denture Rebasing Resin. Sybron Dental: K954810, Myerson IR Denture Base, Austenal, Inc.
The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
These products have the same intended use, as a long-term resilient lining material for removable dentures, as the classified device and many cleared by the 510(k) process under K-964040 (Dentsply), K953589 (Tokuyama), K963736 (Sybron) and K954810 (Austenal).
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The technological characteristics for this product are the same as those for the predicate devices and those currently on the market except for differences in methods of cure. The methods of cure of those equivalent products also vary widely including light-cured, heat-cured, and timecured. Their composition also varies widely but has become fairly standard with acrylics or silicone polymeric substances.
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Descriptive information provided shows that the materials from which Mucopren™ is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market.
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The FDA "Decision-Making Process" chart was also used and appears in Appendix VI.
-
Test data for biocompatibility of Mucopren was supplied in accordance with ODE General Program Memorandum #G95-1, using International Standard ISO 10993 for surface devices having prolonged contact with mucosal membrane. Less formal biocompatibility tests from Europe also were made. These data are supplied in Appendix III.
Image /page/0/Picture/16 description: The image shows a black circle on a white background. The circle is solid black and appears to be slightly off-center. The background is plain white, providing a stark contrast to the black circle. There are some small artifacts on the right side of the circle.
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A specific guidance document is not available for relining, rebasing resin materials. However, we followed the general outline, and applicable parts of the recent guidance document, "Dental Impression Materials--Premarket Notification," issued 8/17/98. We believe we have complied fully with guidance documents and usual practices in preparing premarket notifications. If additional information or explanation is needed, please call me at 248-652-2500 or fax me at 248-652-2505. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, who is acting on my behalf, for a local response.
Sincerely yours
Dnzl Ry
Don LeRov President
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Mr. Don Leroy President ROYDENT Dental Products 1010 West Hamlin Road Rochester Hills, Michigan 48309
K983357 Re : Mucopren™ Soft Relining System Trade Name: Requlatory Class: II Product Code: EBI September 23, 1998 Dated: September 24, 1998 Received:
Dear Mr. Leroy:
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. ਉ 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.
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Page 2 -- Mr. Leroy
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) 594-4692. 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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K9833S7
VIII.1 Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: Mucopren™ soft liner system
Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
3
Over-The-Counter Use__
(Optional Format 1-2-96)
Susan Puoser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 19882277