(95 days)
No
The description focuses solely on the chemical composition and physical properties of dental impression materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to take dental impressions, which is a diagnostic or procedural step, not a therapeutic intervention to treat a disease or condition.
No
Explanation: The device is a dental impression material used to take dental impressions, which is a method of capturing the physical shape of teeth and surrounding tissues. This process is for fabrication purposes (e.g., creating a dental prosthetic) and not for diagnosing a medical condition or disease.
No
The device description clearly states it is a line of dental impression materials, which are physical substances used to take impressions. It discusses the chemical composition and physical properties of these materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To take dental impressions." This is a physical process of creating a mold of a patient's teeth and surrounding structures.
- Device Description: The description details the composition and properties of a dental impression material (vinyl polysiloxane). It focuses on its physical characteristics and how it is used to create an impression.
- Lack of Diagnostic Purpose: The text does not mention any diagnostic purpose for the device or the resulting impression. It is used for creating a physical replica, not for analyzing biological samples or providing diagnostic information.
- No Mention of In Vitro Testing: The description does not involve any testing of samples in vitro (outside the body) for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental impression material does not fit that definition.
N/A
Intended Use / Indications for Use
To take dental impressions.
Product codes
Not Found
Device Description
This 510(k) application is for a line of dental impression materials. Vinyl polysiloxane impression materials have been used in the dental field since 1973. There are presently at least twelve manufacturers worldwide of this type impression material and more than 30 companies selling impression products under private label. Based upon the total impression market, which would include all types of impression materials used, the vinyl addition products have gained the majority share according to current trade reports.
Clinical studies as well as scientific evaluations have shown that the handling characteristics and the physical properties of the vinyl polysiloxane impression materials are superior to all previous impression materials. With the many impression techniques that are used in dentistry today, the vinyl addition system manufacturers have developed a great variety of different materials to satisfy these diverse requirements.
To create these various viscosities and rheological changes in the vinyl system, the type of filler used is changed. Radiopacity can be added by using a small percentage of barium sulfate in the filler addition (K872745, July 1987). Thixotropy to overcome the uncontrolled flow of impression materials which can cause gagging can be accomplished by altering the filler system. Instead of using extending fillers, bulking fillers are used. Aeorsil is an example of such a filler.
Fillers generally are not involved in the chemical reaction between the polymer, crosslinker and platinum complex. The filler particles interspersed between the silicone rubber matrix can alter the viscosity and durometer as well as the elasticity and tear strength of the set material. The efficacy and safety of the product is not altered since the addition silicone reaction is not dependent on the fillers used. The excellent dimensional stability of the vinyl system is also unaffected.
The available fillers that can be used in formulating vinyl polysiloxane impression systems are numerous and each one has a specific characteristic For example, silica is available in several forms. The crystalline type, the amorphous type, the fumed type or the diatomaceous type all have different characteristics when used in system design. When more than one silica is used in a system the change in rheology can be as a result of the properties imparted by each filler.
A further filler that can be used is combining the fumed silica with magnesum silicate, creating a rheologically altered impression material that is very thixotropic, yet fluffy and nonflowing except when some external force is applied. The resultant material can be used for impressions without the inconvenience of uncontrolled flow, which in many instances cause gagging.
Vinyl addition silicone products are used in other health related fields such as rehabilitation and occupational therapy for scar control after primary wound healing and in hearing restoration with externally worn hearing aids by the use of impressions of the outer and part of the middle ear. To our knowledge no reports have been published indicating any untoward reactions when vinyl polysiloxane materials are used in any application including the high volume usage in the dental field.
When used intraorally in dentistry, the impression is contaminated with saliva and blood. Vinyl addition impressions can be disinfected with any hospital level disinfectant or aqueous sterilant to prevent the spread of pathogens from the dental office environment to the dental laboratory technician, thus eliminating possible cross contamination.
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)
K930248, K871409, K781083, K872745, K801380
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FLU 25 1997
Image /page/0/Picture/2 description: The image shows the logo for J. Morita USA. The text "J. MORITA" is in large, bold, sans-serif font. Below this, "USA" is written in a smaller, sans-serif font, set against a black rectangular background. The logo is simple and uses a monochromatic color scheme.
510(k) Summary
The following summary regarding 510(k) safety and effectiveness information for the Perfectim dental impression materials device, regulated under 21 C.F.R. Section 872.3660, was prepared November 4, 1996 and is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 and 21 C.F.R. Section 807.92.
Applicant:
J.Morita USA, Inc. 14712 Bentley Circle Tustin, California 92680
Contact Person: Terry G. Mahn Fish & Richardson 601 13th Street, N.W. . . . . . . . . . . . . . . . . . . . . Suite 500 North Washington, D.C. 20005 Phone: (202) 783-5070 Fax: (202) 783-2331
Classification Name:
Impression material
Usual Name:
Dental impression material
Proprietary Name:
Perfectim
CORPORATION
1
Predicate Devices
The Perfectim line of dental impression materials have the same technological, safety, and effectiveness characteristics, and are substantially equivalent to, the following predicate devices:
| PERFECTIM PRODUCT | PREDICATE DEVICE |
|---|---|
| Blue Velvet | K930248; K871409; K781083 |
| 30 Second Blue Velvet | K930248; K871409; K781083 |
| Flexi-Velvet | K930248; K871409; K781083 |
| Single Phase Body | K872745; K871409; K781083 |
| Final Wash | K801380; K871409; K781083 |
| Preliminary Phase | K930248; K871409; K781083 |
| Secondary Wash | K801380; K871409; K781083 |
| Putty | K801380; K781083 |
Intended Use
To take dental impressions.
Description of Device
This 510(k) application is for a line of dental impression materials. Vinyl polysiloxane impression materials have been used in the dental field since 1973. There are presently at least twelve manufacturers worldwide of this type impression material and more than 30 companies selling impression products under private label. Based upon the total impression market, which would include all types of impression materials used, the vinyl addition products have gained the majority share according to current trade reports.
Clinical studies as well as scientific evaluations have shown that the handling characteristics and the physical properties of the vinyl polysiloxane impression materials are superior to all previous impression materials. With the many impression techniques that are used in dentistry today, the vinyl addition system manufacturers have developed a great variety of different materials to satisfy these diverse requirements.
To create these various viscosities and rheological changes in the vinyl system, the type of filler used is changed. Radiopacity can be added by using a small percentage of barium sulfate in the filler addition (K872745, July 1987). Thixotropy to overcome the uncontrolled flow of impression materials which can cause gagging can be accomplished by altering the filler system. Instead of using extending fillers, bulking fillers are used. Aeorsil is an example of such a filler.
Fillers generally are not involved in the chemical reaction between the polymer, crosslinker and platinum complex. The filler particles interspersed between the silicone rubber matrix can alter the viscosity and durometer as well as the elasticity and tear strength of the set material. The efficacy and safety of the product is not altered since the addition silicone reaction is not dependent on the fillers used. The excellent dimensional stability of the vinyl system is also unaffected.
2
The available fillers that can be used in formulating vinyl polysiloxane impression systems are numerous and each one has a specific characteristic For example, silica is available in several forms. The crystalline type, the amorphous type, the fumed type or the diatomaceous type all have different characteristics when used in system design. When more than one silica is used in a system the change in rheology can be as a result of the properties imparted by each filler.
A further filler that can be used is combining the fumed silica with magnesum silicate, creating a rheologically altered impression material that is very thixotropic, yet fluffy and nonflowing except when some external force is applied. The resultant material can be used for impressions without the inconvenience of uncontrolled flow, which in many instances cause gagging.
Vinyl addition silicone products are used in other health related fields such as rehabilitation and occupational therapy for scar control after primary wound healing and in hearing restoration with externally worn hearing aids by the use of impressions of the outer and part of the middle ear. To our knowledge no reports have been published indicating any untoward reactions when vinyl polysiloxane materials are used in any application including the high volume usage in the dental field.
When used intraorally in dentistry, the impression is contaminated with saliva and blood. Vinyl addition impressions can be disinfected with any hospital level disinfectant or aqueous sterilant to prevent the spread of pathogens from the dental office environment to the dental laboratory technician, thus eliminating possible cross contamination.