VITRO FIL LC

K123824 · Dfl Industria E Comercio SA · EMA · Feb 21, 2013 · Dental

Device Facts

• Record ID: K123824
• Device Name: VITRO FIL LC
• Applicant: Dfl Industria E Comercio SA
• Product Code: EMA · Dental
• Decision Date: Feb 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Vitro Fil LC is a resin-modified glass ionomer dental cement. It functions as a temporary tooth filling, base cement for temporary fillings, cement for dental devices (crowns/bridges), or pulp protection. The material provides chemical adhesion to tooth structure, fluoride release, and biocompatibility. It is applied by dental professionals in a clinical setting. The device is used to restore tooth structure or affix dental prosthetics, benefiting the patient through structural reinforcement and protection of the tooth pulp.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-modified glass ionomer dental cement. Features include chemical adhesion to tooth structure, fluoride release, and biocompatibility. Formulated as a non-zinc oxide-eugenol cement. Intended for permanent cementation and restorative applications.

Indications for Use

Indicated for patients requiring Class III, Class V, or small Class I restorations, restoration of root surface caries, cervical erosion repair, primary teeth restoration, core build-up, and use as a liner.

Regulatory Classification

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. 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.

Predicate Devices

• Vitremer (K925032)
• ProGlass Two LC (K101869)
• Fuji II LC (K913884)

Submission Summary (Full Text)

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K123824

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- [phone] FAX- [phone]

| 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<br>(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.

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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.

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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.

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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 [phone] or [phone] 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

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#### 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:**