(65 days)
Premise, Premise Flowable, Optibond Solo Plus 2
Not Applicable
No
The document describes a dental restorative material and its intended uses, with no mention of AI or ML technology.
No
This device is a dental restorative material used for direct restorations and repairs, which is structural rather than therapeutic in nature.
No
The device is a restorative material for dental use and does not perform any diagnostic function. Its intended uses are for direct restorations, repairs, and sealants.
No
The device description clearly states it is a "self-adhesive, light cured resin based composite dental restorative," 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 clearly describes the device as a material for direct dental restorations and repairs within the mouth. This is a therapeutic and restorative application, not a diagnostic one.
- Device Description: The description confirms it's a "resin based composite dental restorative designed for direct placement." This further reinforces its use as a material for treating dental issues, not for diagnosing them.
- Lack of Diagnostic Elements: 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 specifically designed for these purposes.
Therefore, DMC Composite 2 is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries.
DMC Composite 2 Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal buildups in non-stress bearing areas, incisal abrasions, small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.
Product codes
EBF, EBC
Device Description
DMC Composite 2 is a self-adhesive, light cured resin based composite dental restorative designed for direct placement. DMC Composite 2 is offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-Clinical Test Data: Because the addition of the new indications would not result in any formula changes to DMC Composite 2, there is no reason to suspect that the safety and biocompatibility of DMC Composite 2 would be adversely affected.
Clinical Testing: Clinical testing has not been conducted on this product.
Key Metrics
Not Found
Predicate Device(s)
Premise, Premise Flowable, Optibond Solo Plus 2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
X AND/OR Over-The-Counter Use ______ |
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| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices Page 1 of 1
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