(304 days)
Not Found
No
The summary describes dental cements and does not mention any AI or ML capabilities.
No
The device is a dental cement used for the permanent adhesion of various dental restorations, which is not considered a therapeutic function.
No
The devices described (TotalCem and DentoCem) are dental cements used for bonding or luting dental restorations. Their intended use is for "cementation" and "permanent cementation" of items like crowns, bridges, and inlays, which are restorative functions, not diagnostic ones. There is no mention of these devices being used to identify or analyze diseases or conditions.
No
The device descriptions clearly indicate that TotalCem and DentoCem are physical resin cements, not software.
Based on the provided information, neither TotalCem nor DentoCem are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use for both devices is the cementation of various dental restorations (posts, crowns, bridges, etc.). This is a direct application within the body (or on structures that will be placed in the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The descriptions confirm they are resin cements used for bonding dental materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, these devices fall under the category of dental materials used for restorative procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Device Name: TotalCem
The device is intended for the cementation of posts, crowns, bridges, inlays and onlays.
Device Name: DentoCem
The device is intended for permanent cementation of:
- crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers;
- . implant prosthesis:
- orthodontic attachments:
- amalgam restorations:
- veneering of alloys: and ●
- composite restorations. .
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement. The technological characteristics for this subject device are as follows:
Matrix: UDMA and BIS-GMA
Fillers: Barium glass and Fumed Silica, TiO2
Delivery: Automix
Curing Method: Dual Cure
Radiopacity (% Al): Yes
DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components. The technological characteristics for this subject device are as follows:
Matrix: UDMA and BIS-GMA
Fillers: Barium glass and Fumed Silica TiO2
Delivery: Automix
Curing Method: Dual Cure
Radiopacity (% Al): Yes
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)
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, Itena Clinical has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.
Conclusion Drawn: Based on their indications for use, technological characteristics and comparison to predicate devices, the subject devices have been shown to be safe and effective for their intended use. Further, combined with biocompatibility testing and based on a comparison of intended use and indications for use, physical properties and composition, Itena Clinical concludes that the subject devices are substantially equivalent to their respective predicates (respectively, Ivoclar Vivadent MultiLink (K032470) and 3M ESPE's predicate device, RelyXim Luting Plus Cement (K02247) and DMG, USA Permacem (K012316).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
KIZI 804
Abbreviated 510(k) Summary
Fax:
(514) 397-8515
Email: Ipmarin@bcf.ca
APR 1 9 2013
| 1. | Name/Address of Submitter: | Itena Clinical |
|---|---|---|
| 83 avenue Foch | ||
| 75116 Paris | ||
| FRANCE | ||
| 2. | Contact Person: | Louis-Paul Marin |
| Co-President, BCF Certification inc. | ||
| Phone: (514) 397-5546 |
- Date Summary Prepared: April 25 , 2012
-
- Devices Names: TotalCem, DentoCem
- ડ. Device Classification: II
-
- Common name: Dental Cement
-
- Classification Product Code: EMA
-
- Predicate Devices:
| TotalCem | MultiLink | |
|---|---|---|
| K032470 | ||
| DentoCem | RelyX Luting Plus Cement | PremaCem |
| K022476 | K012316 |
0. Devices Description:
TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement. The technological characteristics for this subject device are as follows:
| Technological
Characteristics | Subject Device | MultiLink
K032470 |
|----------------------------------|----------------------------------------|-------------------------------------------------------------------|
| Matrix | UDMA and BIS-GMA | UDMA and BIS-GMA |
| Fillers | Barium glass and Fumed
Silica, TiO2 | Barium glass, ytterbium
trifluoride and spheroid
mixedoxide |
| Delivery | Automix | Automix |
1
| Curing Method | Dual Cure | Dual Cure |
|---|---|---|
| Radiopacity (% Al) | Yes | Yes |
- DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components. The technological characteristics for this subject device are as follows:
| · Technological Characteristics | Subject Device | PremaCem
K012316 |
|---------------------------------|---------------------------------------|-------------------------|
| Matrix | UDMA and BIS-GMA | UDMA and Bis-GMA |
| Fillers | Barium glass and Fumed Silica
TiO2 | Barium glass and Silica |
| Delivery | Automix | Automix |
| Curing Method | Dual Cure | Dual Cure |
| Radiopacity (% Al) | Yes | Yes |
10. Statement of Intended Use:
Device Name: TotalCem
The device is intended for the cementation of posts, crowns, bridges, inlays and onlays.
Device Name: DentoCem
The device is intended for permanent cementation of:
- crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers;
- . implant prosthesis:
- orthodontic attachments: �
- amalgam restorations:
- veneering of alloys: and ●
- composite restorations. .
- Brief Description of Clinical and Non-clinical Testing: 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, Itena Clinical has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.
Conclusion Drawn: Based on their indications for use, technological characteristics and comparison to predicate devices, the subject devices have been shown to be safe and effective for
2
their intended use. Further, combined with biocompatibility testing and based on a comparison of intended use and indications for use, physical properties and composition, Itena Clinical concludes that the subject devices are substantially equivalent to their respective predicates (respectively, Ivoclar Vivadent MultiLink (K032470) and 3M ESPE's predicate device, RelyXim Luting Plus Cement (K02247) and DMG, USA Permacem (K012316).
3
Image /page/3/Picture/0 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 image of an eagle or other bird-like figure, with its wings spread and head turned to the side.
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
April 19, 2013
Itena Clinical C/O Mr. Louis-Paul Marin Co-President BCF Certification, Incorporated 500 Boul Cartier West Laval, Canada H7V 5B7
Re: K121804
Trade/Device Name: TotalCem, DentoCem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 27, 2013 Received: April 3, 2013
Dear Mr. Marin:
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.
4
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Kwame O.
Ulmer-S
for
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
5
K121804 Indication for Use
Device Name: TotalCem
Indication for Use: It is intended for the cementation of posts, crowns, bridges, inlays and onlays.
Device Name: DentoCem
Indication for Use: It is intended for permanent cementation of:
- crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, � Maryland bridges and veneers;
- implant prosthesis; ●
- orthodontic attachments; ●
- . amalgam restorations;
- . veneering of alloys; and
- composite restorations.
Concurrence of CDRH Office of Device Evaluation
l - l
OR
Prescription Use X 801.109)
| Over-the-counter Use | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| ---------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mary S. Runner - S | |
|---|---|
| Susan Runner, DDS, MA | |
| 2013.04.17 | |
| 10:36:45 -04'00' |
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: