(64 days)
Not Found
No
The device description and intended use are for a traditional dental cement with no mention of AI/ML capabilities or related data/performance metrics.
No
The device is a restorative material (glass ionomer cement) used for dental fillings, not a therapeutic device designed for treatment or diagnosis of disease.
No
The device is described as a restorative dental material (glass ionomer cement) used for fillings and core build-ups, not for identifying or investigating diseases or conditions.
No
The device description clearly states it is a "condensable, chemically activated glass ionomer cement," which 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/Indications for Use: The intended uses are for dental restorations (fillings, core build-up, liner). These are procedures performed directly on the patient's teeth.
- Device Description: The description details a dental cement used for filling cavities and building up tooth structure. It hardens via a chemical reaction and is applied directly to the tooth.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is a material used for direct treatment of a dental issue.
N/A
Intended Use / Indications for Use
- . Class I, Class II, Class III and Class V restorations
- Non-bearing Class I and Class II restorations in permanent teeth .
- Intermediate restoration for heavy stress situations in Class I and Class II . cavities
- Core build up .
- Liner .
Product codes
EMA
Device Description
Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fuji IX GP K961448, Ketac-Molar Aplicap K960954
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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. Below "Nova" is the letters "DFL" in a bold, sans-serif font. The logo appears to be for a dental or oral health-related company.
"":"
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be "K123&26". The handwriting is somewhat stylized, with the numbers and ampersand being more rounded. The image is in black and white.
SECTION 7
FEB 1 4 2013
SUMMARY OF SAFETY AND EFFECTIVENESS
Proprietary Name
Vitro Molar
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 TechLink International Consulting 18851 NE 29th 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 | Fuji IX GP K961448 |
| Ketac-Molar Aplicap K960954 |
Description of Proposed Device
Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.
Indications for Use
- . Class I, Class II, Class III and Class V restorations
- Non-bearing Class I and Class II restorations in permanent teeth .
Page 1 of 2 Summary
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 text "Nova DFL" on the right side. The word "Nova" is smaller and placed above the word "DFL". The logo is black and white.
- Intermediate restoration for heavy stress situations in Class I and Class II . cavities
- Core build up .
- Liner .
Substantial Equivalence
All of the components of Vitro Molar are found in legally marketed devices. Vitro Molar 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 Molar and the predicates are the similar.
Conclusion
Based on the information provided in this premarket notification, we can conclude that Vitro Molar is as safe and effective as the predicated devices.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or bird in flight, represented by three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
DFL Industria E Comercio S.A. C/O Ms. Tara Conrad Regulatory Affairs Manager TechLink International 18851 North East 29th Avenue 720 AVENTURA FL 33180
Re: K123826
Trade/Device Name: Vitro Molar 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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
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 Molar
510(k) Number: (Pending) K (23826
Indications for Use:
- Class I, Class II, Class III and Class V restorations .
- Non-bearing Class I and Class II restorations in permanent teeth .
- Intermediate restoration for heavy stress situations in Class I and Class . II cavities
- Core build up .
- Liner o
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, DDS | |
| 2013.02.15 | |
| 10:02:09 -05'00' | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K123826 |