(59 days)
Not Found
No
The device description and intended use are for a physical impression material, and there is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is used for making dental impressions and as a matrix for temporary crowns and bridges, which are diagnostic and restorative functions rather than therapeutic.
No
The device is described as an impression material used to record the occlusal relationship of dental arches and as a matrix for fabricating temporary crowns and bridges. Its purpose is to create models or matrices, not to diagnose a medical condition.
No
The device description clearly states it is a "two-part vinyl polysiloxane paste" and is extruded from "dual-barrel cartridges," 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 making impressions of the occlusal relationship of dental arches and as a matrix for temporary crowns and bridges. This is a mechanical/physical function within the mouth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a material used for creating physical impressions and matrices. It doesn't mention any analysis of biological samples or diagnostic procedures.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the teeth and oral structures.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
3MTM M.G. Material is designed for making impressions that record the occlusal relationship of the upper and lower dental arches. It is also intended to be used as a matrix when fabricating temporary crowns and bridges.
Product codes
ELW
Device Description
3MTM M.G. Material is designed to make fast, accurate, and rigid interocclusal records. The material has a consistency which resists slumping and offers minimal resistance to closure to ensure proper occlusion. 3M™ M.G. Material may also be used as a matrix material when fabricating custom temporary crowns and bridges. It is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the occlusal surfaces of the teeth. The material quickly cures into a rigid impression.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K981325: 3MTM ImprintTM II Vinyl Impression Material System, 3MTM Fast Set Bite Registration Material, Heraeus Kulzer MemoregTM C.D. Bite Registration Material, Parkell Blu-Mousse® AutoMix Cartridges
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
3M Dental Products Laboratory
3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 612 733 3149
Jun | | 1998
K98 1325
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Name: | Amy E. Fowler |
|---|---|
| Address: | 3M Dental Products Laboratory |
| 3M Center, Building 260-2B-12 | |
| St. Paul, MN 55144-1000 | |
| Phone: | (612) 736-1590 |
| Fax: | (612) 736-0990 |
| E-mail: | aefowler@mmm.com |
| Date: | April 10, 1998 |
| Trade Name: | 3MTM M.G. Material |
| Common Names: | Bite registration material, occlusal registration material |
| Classification Name: | Impression material |
| (21 CFR 872.3660) Class II | |
| Predicate devices: | 3MTM ImprintTM II Vinyl Impression Material System |
| 3MTM Fast Set Bite Registration Material | |
| Heraeus Kulzer MemoregTM C.D. Bite Registration Material | |
| Parkell Blu-Mousse® AutoMix Cartridges |
3MTM M.G. Material is designed to make fast, accurate, and rigid interocclusal records. The material has a consistency which resists slumping and offers minimal resistance to closure to ensure proper occlusion. 3M™ M.G. Material may also be used as a matrix material when fabricating custom temporary crowns and bridges. It is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the occlusal surfaces of the teeth. The material quickly cures into a rigid impression.
3MTM M.G. Material is designed for making impressions that record the occlusal relationship of the upper and lower dental arches. It is also intended to be used as a matrix when fabricating temporary crowns and bridges. The predicate devices do not specifically say they are intended for use as matrices. However, the labeling for temporary crown and bridge materials has indirectly indicated the predicate devices for this use for many years. This use does not present any new issues of safety or efficacy.
3MTM M.G. Material and the predicate devices have similar technological characteristics as indicated by their vinyl polysiloxane addition-cure chemistry. This is further validated by the comparative results of the bench tests conducted, including strain in compression, detail reproduction, mixed consistency, and linear dimensional change.
Based on the safety analysis and the bench tests, 3MTM M.G. Material is safe, effective, and performs as well or better than the predicate devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected and appear to be part of a single, flowing shape. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | | 1998
Ms. Amy E. Fowler · Regulatory Affairs 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000
Re : K981325 3M M.G. Material Trade Name: Regulatory Class: II Product Code: ELW Dated: April 10, 1998 Received: April 13, 1998
Dear Ms. Fowler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual registration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Fowler
through 542 of the Act for devices under the Electronic Chrough 542 of the not al provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia wi puivalence of your device to a legally marketed predicate device results in a classification for your marketed produces ormits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ......
3
510(k) Number:
Device Name: 3M™ M.G. Material
Indications For Use:
Indications I or Ose. material when fabricating custom temporary crowns and bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runver | |
|---|---|
| (Division Sign-Off) | |
| Division of | |
| and General Hospital Devices | |
| 510(k) Number | K98 825 |
| Prescription Use | (Per 21CFR 801.109) |
|---|---|
| ------------------ | ----------------------------------------- |
OR
Over-the Counter Use