(90 days)
Not Found
No
The description is for a physical dental impression material and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
The device is a dental impression material used to reproduce the structure of teeth and gums for creating restorations, not to treat or cure a disease or condition.
No
The device is described as an impression material used to reproduce the structure of teeth and gums for creating dental restorations, not for diagnosing medical conditions.
No
The device is a physical dental impression material, not a software-only medical device. The description clearly states it is a "vinyl polysiloxane dental impression material" and an "addition-reaction silicone impression material."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reproduce the structure of a patient's teeth and gums for the production of dental restorations. This is a physical process for creating a mold, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition or provide information about a physiological state.
- Device Description: The description confirms it's a dental impression material, a physical substance used to create a mold.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVDs are typically used to test blood, urine, tissue, or other bodily fluids to detect diseases, infections, or other health conditions. This device is used to create a physical replica of a patient's oral anatomy.
N/A
Intended Use / Indications for Use
This VPS impression material is intended to be placed on an impression tray and used to reproduce the structure of a patient's teeth and gums in order to produce crowns, bridges, implants and other dental restorations. This product is for professional use only by or on the order of a licensed dentist.
Range of Indications:
System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.
Product codes
ELW
Device Description
System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.
| PROPERTY | MEDIUM BODY | LIGHT BODY |
|---|---|---|
| Consistency, ISO 4823 | Medium Body, Type 2 | Light Body, Type 3 |
| Color | yellow | blue |
| Working Time (Including Mixing) | 30-60 seconds | 30-60 seconds |
| Time in Mouth | three minutes | three minutes |
| Total Setting Time (Including Mixing) | four minutes | four minutes |
| Strain in Compression % | 4.7% | 4.7% |
| Shrinkage after 24hr |
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
K 073475
Summary of Safety and Effectiveness
MAR 1 0 2008
System Plus Impression Material
| 1. | Date of Summary
Preparation: | June 22, 2007 |
|----|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitting Firm: | Continental Dental Laboratory |
| 3. | Contact Person: | Jerry Doviack, CDT
President
Continental Dental Laboratory
1873 Western Way
Torrance, CA 90501
T: (310) 618-8821
F: (310) 618-1238 |
| 4. | Name of Medical Device
Proprietary Name: | System Plus Impression Material |
| | Common Name: | Dental Impression Material |
| | Classification Name: | Impression Material |
-
- Description of Medical Device:
System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.
- Description of Medical Device:
| PROPERTY | MEDIUM BODY | LIGHT BODY |
|---|---|---|
| Consistency, ISO 4823 | Medium Body, Type 2 | Light Body, Type 3 |
| Color | yellow | blue |
| Working Time | ||
| (Including Mixing) | 30-60 seconds | 30-60 seconds |
| Time in Mouth | three minutes | three minutes |
| Total Setting Time | ||
| (Including Mixing) | four minutes | four minutes |
| Strain in Compression % | 4.7% | 4.7% |
| Shrinkage after 24hr |