(38 days)
Not Found
Not Found
No
The description focuses on the material properties and traditional dental impression techniques, with no mention of AI or ML.
No
The device is a dental impression material used for diagnostic and restorative purposes, not for treating a disease or condition.
No
The device is described as a dental impression material used to reproduce structures and for bite registration, not to diagnose a condition or disease.
No
The device description clearly states it is a "vinyl polymethyl siloxane dental impression material," which is a physical substance, 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 to reproduce the structures of a patient's teeth and gums for dental impressions and bite registration. 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.
- Device Description: The description details a dental impression material used for physical molding techniques. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
Therefore, A-SILICONE is a dental material used for physical impressions and registration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth and gums
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
§ 872.3660 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
Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for A-Silicone Page 12 of 15
JUN 1 7 2004
510(k) SUMMARY
As required by the Safe Medical Devices Act of 1990
A-SILICONE
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES
Bisco TWINZ VPS Heraeus Kulzer FLEXITIME
The two indicated predicate devices are addition reaction silicone impression materials also known as vinyl polysiloxane impression materials. The viscosity range is similar to A-SILICONE in that they contain examples of putty based, heavy body, medium body and light body products intended for identical uses in dentistry, that is, for taking impressions of teeth, prepared teeth, oral soft tissue, and bite registrations.
| | Cosmedent
A-SILICONE | Heraeus Kulzer
FLEXITIME1-2 | Bisco
TWINZ VPS3-4 |
|------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | Auto-mix,
elastomeric dental
impression
material | Auto-mix,
elastomeric dental
impression
material | Auto-mix,
elastomeric dental
impression
material |
| Composition | Addition reaction,
silica filled
polydimethyl
siloxane | Addition reaction,
silica filled
polydimethyl
siloxane | Addition reaction,
silica filled
polydimethyl
siloxane |
| Clinical properties | Multiple
viscosities
permitting dual-
mix, monophase,
and putty-wash
techniques | Multiple
viscosities
permitting dual-
mix, monophase,
and putty-wash
techniques | Multiple
viscosities
permitting dual-
mix, monophase,
and putty-wash
techniques |
| Viscosities or grades
available | Putty, heavy body,
medium body, and
light body | Putty, Heavy
body, medium
body, and
corrective light
body | Putty, heavy
body, medium
body, light body,
and extra light
body |
SUBSTANTIAL EQUIVALENCE Summary
1
A-SILICONE 510(k) SUMMARY (cont)
DESCRIPTION OF THE APPLICANT DEVICE - A-SILICONE
A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.
| PROPERTY | Putty | Heavy Body | Medium
Body | Light
Body |
|--------------------------------------|--------------------------|----------------------|-----------------------|----------------------|
| Consistency, ISO 4823 | heavy body
type 0 | heavy body
type 1 | Medium body
type 2 | Light body
type 3 |
| Color | light green | turquoise | lilac | pink |
| Working time including
mixing | 45 seconds to one minute | | | |
| Time in the mouth | two minutes | | | |
| Total setting time,
minimum | 2 minutes - 45 seconds | | | |
| Strain in compression, % | 99.4 | >99.4 | >99.6 | >99.6 |
| Linear dimensional change,
%, max | 0.2 | 0.15 | 0.15 | 0.15 |
| Hardness Shore A | 70 | 50 | 45 | 40 |
MATERIALS SPECIFICATIONS
INTENDED USES OF THE APPLICANT DEVICE
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
Jami K. Sanchez
James L. Sandrik, Ph.D.
Cosmedent, Inc. Suite 2500 401 N. Michigan Ave. Chicago, Illinois 60611
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized lines representing the wings or body.
JUN 1 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dr. James L. Sandrik Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re: K041229
Trade/Device Name: Multiple (A-Silicone) Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 7, 2004 Received: May 10, 2004
Dear Dr. Sandrik:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becareermined the device is substantially equivalent (for the icitications for use stated in the enclosure) to legally marketed predicate devices marketed in multions for asso states in May 28, 1976, the enactment date of the Medical Device Interstate commerce prior st hat have been reclassified in accordance with the provisions of Amendinents, or to ac nove aller metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rist stion, 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 If your device is classinod (oos aboutional controls. Existing major regulations affecting (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
3
Page 2 -Dr. Sandrik
Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 12 a determination that your device complies with other requirements modi that I Dri may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal states requirements, including, but not limited to: registration r ou must comply Will and 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 CF rear 807), and iity systems (QS) regulation (21 CFR Part 820); and if requirements us set form in artistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse obger finding of substantial equivalence of your device to a premarket notification. - The Pore 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), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 5 of 15
INDICATIONS FOR USE
510(k) Number (if known): KO41229
Device Name: MULTIPLE (A-SILICONE)
Indication For Use:
- A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
- A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Susan Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: KO41083