(71 days)
No
The device description and the absence of mentions of AI, DNN, or ML, along with the lack of information on training/test sets and performance metrics, indicate that this is a traditional dental cement without AI/ML components.
No
The device, Vitro Fil LC, is a dental cement used for restorations and as a base cement, which focuses on repairing and reinforcing teeth rather than treating a disease or disorder.
No
The device is described as a dental cement used for restorations, fillings, and affixing dental devices. Its function is to structurally reinforce and bond, not to diagnose a condition.
No
The device description clearly states it is a dental cement composed of various materials, indicating it 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 uses are all related to the direct treatment and restoration of teeth within the patient's mouth (in vivo). This includes filling cavities, restoring root surfaces, core build-ups, and acting as a liner or cement.
- Device Description: The description clearly states it's a "dental cement" used for "temporary tooth filling," "base cement to affix a temporary tooth filling," "affix dental devices," and "applied to a tooth to protect the tooth pulp." These are all applications within the oral cavity.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to diagnose a condition or disease.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the living body).
N/A
Intended Use / Indications for Use
- Class III and Class V restorations .
- Restoration of root surface caries .
- Restorations of cervical erosions .
- Small Class I restorations .
- Primary teeth restoration .
- . Core build up
- Liner .
Product codes
EMA-21 CFR §872.3275
Device Description
Virto Fil LC is a dental cement that is composed of varoius materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges or to be applied to a tooth to protect the tooth pulp. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.
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)
Vitremer (K925032), ProGlass Two LC (K101869) and Fuji II LC (K913884)
Reference Device(s)
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a logo for Nova DFL. The logo consists of two teeth on the left side. To the right of the teeth is the word "Nova" in a stylized font, above the letters "DFL" in a larger, bold font.
FEB 2 1 2013
. . . . . . . .
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
Proprietary Name Vitro Fil LC
Date Prepared December 4, 2012
Submitter
DFL Industria E Comercio S.A. Estrada do Guerengue, 2059- Jacarepagua Rio de Janerio-RJ-Brazil CEP 22713-002
Official Contact
Tara Conrad and Lilian Llufl TechLink International Consulting 18851 NE 29" Avenue Suite 720 Aventura, FL 33180 TEL- (305) 377-0077 FAX- (305) 377-0088
| Common Name | Dental Cement |
|---|---|
| Regulation Number & Product Codes | EMA-21 CFR §872.3275 |
| Proposed Regulatory Class | Class II |
| Predicate Device Identification | Vitremer (K925032), ProGlass Two LC |
| (K101869) and Fuji II LC (K913884) |
Description of Proposed Device
Virto Fil LC is a dental cement that is composed of varoius materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges or to be applied to a tooth to protect the tooth pulp. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.
1
Image /page/1/Picture/0 description: The image shows a logo for Nova DFL. The logo consists of two teeth on the left side, followed by the word "Nova" in a stylized font. To the right of "Nova" is the abbreviation "DFL" in a bold, sans-serif font. The logo appears to be for a dental or oral health-related business.
Indications for Use
- Class III and Class V restorations .
- Restoration of root surface caries .
- Restorations of cervical erosions .
- Small Class I restorations .
- Primary teeth restoration .
- . Core build up
- Liner .
Substantial Equivalence
All of the components of Vitro Fil LC are found in legally marketed devices. Vitro Fil LC has the same intended use and similar technical characteristics as the above mentioned predicate devices. The indications for use, materials, form factor, performance and safety characteristics between Vitro Fil LC and the predicates are the similar.
Conclusion
Based on the information provided in this premarket notification, we can conclude that Vitro Fil LC is as safe and effective as the predicated devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized, curved lines that resemble a triple helix or a stylized representation of human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
DFL Industria E Comercio S.A. C/O Ms. Tara Conrad Regulatory Affairs Manager TechLink International Consulting 18851 NE 29th Avenue, Suite 720 AVENTURE FL 33180
Re: K123824
Trade/Device Name: Vitro Fil LC Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 4, 2012 Received: December 12, 2012
Dear Ms. Conrad:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Ms. Conrad
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner
Susan Runner, DOSMA 2013.02.21
00
12:43:48-05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Device Name: Vitro Fil LC
510(k) Number: (Pending) KICS BUY
Indications for Use:
- As a structural reinforcement for fabricating and/or repairing Class III ● and Class V restorations
- Restoration of root surface caries .
- Restorations of cervical erosions �
- Small Class I restorations .
- Primary teeth restoration �
- Core build up ●
- Liner
Prescription Use_(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
| Mary S. Runner | |
|---|---|
| Susan Runner, DDSMA | 2013.02.20 10:43:04 |
| 00 | |
| -05'00 |
thesiology, General Hosp
510(k) Number: