(80 days)
Not Found
No
The device description and intended use clearly define it as a dental restorative material, with no mention of AI or ML capabilities. The performance studies focus on material properties and conformity to ISO standards, not algorithmic performance.
No
MagicFil is a restorative material used for filling teeth, not for treating a disease or condition. While it has a medical purpose, it functions as a material to repair rather than to actively heal or prevent a disease process.
No
The device is described as a restorative material for teeth, not a device used to diagnose a medical condition or disease.
No
The device description clearly states it is a "restorative 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/Indications for Use: The intended use is for the restoration of deciduous teeth. This is a direct treatment or repair of a physical structure within the body.
- Device Description: The description confirms it's a restorative material applied to teeth.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, diagnose a condition, or monitor treatment.
IVDs are used outside the body to examine samples and provide diagnostic information. This device is used inside the mouth to restore teeth.
N/A
Intended Use / Indications for Use
MagicFil is a dual cure compomer restorative material with additional colors and glitter for the restoration of deciduous teeth.
Product codes
EBF
Device Description
MagicFil is a dual cure (chemical and/or light cure) restorative material with an aesthetic glitter effect for use as a semipermanent restorative material (e.g., for deciduous teeth).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
deciduous teeth
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG USA Inc. has provided information to demonstrate conformity with ISO Standard 4049:2000 Dentistry - Polymer-based filling, restorative and luting materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BISCO Resinomer (K924151), Vivadent/Ivoclar Compoglass (K974577)
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
K0135~71
510(k) Summary
| Trade Name: | MagicFil |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Device Generic Name: | Dental restorative material |
| Classification: | According to Section 513 of the Federal Food, Drug, |
| and Cosmetic Act, the device classification is Class II. |
Regulation/Product Code: 21 CFR 872.3690/EBF
Predicate Devices:
The proposed DMG USA MagicFil material is substantially equivalent to other currently marketed dental restorative materials including BISCO Resinomer (K924151) and Vivadent/Ivoclar Compoglass (K974577).
Product Description:
MagicFil is a dual cure (chemical and/or light cure) restorative material with an aesthetic glitter effect for use as a semipermanent restorative material (e.g., for deciduous teeth).
Indications for Use:
MagicFil is a dual cure compomer restorative material with additional colors and glitter for the restoration of deciduous teeth.
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG USA Inc. has provided information to demonstrate conformity with ISO Standard 4049:2000 Dentistry - Polymer-based filling, restorative and luting materials.
Conclusion:
Based on its indications for use, technological characteristics, and comparison to predicate devices, the MagicFil material has been shown to be safe and effective for its intended use.
00031
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a way that resembles a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 7 2002
DMG USA, Incorporated C/O Ms. Pamela Papineau Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K013571
Trade/Device Name: MagicFil Regulation Number: 872.3690 Regulation Name: Dental Resin Based Restorative Material Regulatory Class: II Product Code: EBF Dated: October 22, 2001 Received: October 29, 2001
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Ms. Papineau
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 _ of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ MagicFil
Indications for Use:
MagicFil is a dual cure compomer restorative material with additional colors and glitter for the restoration of deciduous teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / (Per 21 CFR 801.109) OR
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________
Susa Runa
(Division Sign-Off) Division Sign-Only
Division of Dental, Infection Control, and General Hospital and General Hospital Devices
510(k) Number ___________________________________________________________________________________________________________________________________
000008