(92 days)
Not Found
Not Found
No
The device description details a conventional heat cure denture base material made of standard chemical components, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a material used for fabricating dentures, which are prosthetic devices, not therapeutic devices.
No
The intended use statement indicates that the device is "intended for use in the fabrication of full and partial dentures," which describes a manufacturing or restorative function, not a diagnostic one. Diagnostic devices are used to identify a condition or disease.
No
The device description clearly states it is a "conventional dough pack heat cure denture base material" consisting of physical components like polymer powder and monomer, indicating it 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 full and partial dentures." This is a manufacturing process for a medical device (dentures), not a diagnostic test performed on a sample taken from the human body.
- Device Description: The description details the chemical composition of a material used to create dentures. It does not describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
In summary, the Myerson Economy Denture Base Material is a material used to construct a medical device (dentures), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Myerson Economy Denture Base Material is a conventional dough pack heat cure denture base material that consists of a polymethyl methacrylate polymer powder with a heat cure monomer consisting of methyl methacrylate, crosslinker (either EGDMA or TEGDMA), 0-1% UV Light Absorber.
The polymer is shaded to simulate the color of gum tissue using pigments that appear on the FDA list of approved products.
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.
Not Found
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
.
4101 W. 51ST STREET
CHICAGO, IL 60632-4287
TEL 312.735.0600
800.621.0381
FAX 312.735.3940
MAY 1 4 1997
510(k) Notification Summary-Myerson Economy Denture Base Material
Myerson Economy Denture Base Material is intended for use in the fabrication of full and partial dentures.
The Myerson Economy Denture Base Material is a conventional dough pack heat cure denture base material that consists of a polymethyl methacrylate polymer powder with a heat cure monomer consisting of methyl methacrylate, crosslinker (either EGDMA or TEGDMA), 0-1% UV Light Absorber.
The polymer is shaded to simulate the color of gum tissue using pigments that appear on the FDA list of approved products.
This product is substantially equivalent to predicate denture base systems currently on the market which are either pre-amendment devices marketed via 510(K) notification.
The safety and effectiveness of these systems are well documented in the dental literature and the subject products have been formulated to comply with the applicable American Dental Association Standards for denture base materials and repair denture base materials.