(85 days)
Not Found
No
The document describes a chemically activated acrylic resin for temporary dental prostheses and does not mention any computational or data-driven components.
No
The devices are materials for constructing temporary dental prostheses, which are restorative rather than therapeutic. They are used for repair and fabrication, not for treating diseases or conditions.
No
The device is described as materials for the construction and repair of temporary dental prostheses, not for diagnosing medical conditions.
No
The device is described as a material (powder and liquid) used for constructing temporary dental prostheses, which are physical objects, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this material is used for constructing temporary dental prostheses (crowns and bridges) and repairing existing ones. This is a material applied to the patient, not used to analyze samples from the patient.
- The intended use is for dental restoration. The listed uses are all related to creating or repairing dental devices that are placed in the mouth.
- There is no mention of analyzing biological samples. The description focuses on the chemical composition and how the material is used in a dental setting.
Therefore, this device falls under the category of a dental material or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
temporary.cold.v and self-cure dentine are temporary cold-curing indirect crowns & bridges materials, Poly-methyImethacrylate based. Powder and liquid.
Intended use:
- Construction of temporary crowns and bridges -
- Immediate crown brush-modeling
- For gypsum or silicone key pouring technique -
- For rapidly repairing acrylic crowns and bridges -
Product codes
EBG
Device Description
Temporary.cold.v and self-cure dentine are chemically activated poly(methylmethacrylate) based, crown and bridge materials for temporary dental prosthesis.
They can be used for:
- Construction of temporary crowns and bridges .
- . Immediate crown brush-modeling
- . For gypsum or silicone key pouring technique
- . For rapidly repairing acrylic crowns and bridges
Temporary.cold.v and self-cure dentine are self-curing acrylic resins composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
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
dental practitioners
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)
The materials technical data (tests performed by NIOM Laboratory - Norway) are the following:
| Temporary.cold.v | Self-cure.dentine | |
|---|---|---|
| Flexural strength | 44N | 45N |
| Water absorption | 18,2-18,7 µg/mm³ | 23,1-25 µg/mm³ |
| Water solubility | 1,3-2,3 µg/mm³ | 0,2-1,7 µg/mm³ |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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510(K) SUMMARY
Image /page/0/Picture/3 description: The image shows a logo for Major Dental. The logo features a stylized letter "M" at the top, which is large and bold. Below the "M", the word "MAJOR" is written in a sans-serif font, with the letters spaced slightly apart. Underneath "MAJOR", the word "DENTAL" is written in a smaller font, also sans-serif, and with similar letter spacing.
MAJOR Prodotti Dentari S.p.A. Via Luigi Einaudi, 23, 10024 Moncalieri (TO) - ITAL Y Tel +39.011.6400.211 - Fax +39.011.6400.222 E-mail: info@majordental.com - Internet: www.majordental.com
SUBMITTER
| Name | MAJOR Prodotti Dentari S.p.A. |
|---|---|
| Address | Via Luigi Einaudi, 23 |
| I-10024 Moncalieri (TO) | |
| ITALY | |
| Facility registration | |
| number | 4565 |
| Contact person | Monica Funai |
| Phone number | +39.011.6400.211 |
| Fax number | +39.011.6400.222 |
| m.funai@majordental.com | |
| Document issued on | September 10, 2008 |
NAME OF DEVICE
| Proprietary name | temporary.cold.v and self-cure dentine |
|---|---|
| Common name | Temporary crown & bridge resin |
| Classification name | Crown and Bridges, Temporary, Resin |
| (21 CFR 872.3770, Product Code EBG) | |
| Predicate Devices | Trim® Plus by Harry J. Bosworth ......................K961199 |
DESCRIPTION OF THE DEVICE
Temporary.cold.v and self-cure dentine are chemically activated poly(methylmethacrylate) based, crown and bridge materials for temporary dental prosthesis.
They can be used for:
- Construction of temporary crowns and bridges .
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- . Immediate crown brush-modeling
- . For gypsum or silicone key pouring technique
- . For rapidly repairing acrylic crowns and bridges
Temporary.cold.v and self-cure dentine are self-curing acrylic resins composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Temporary.cold.v and self-cure dentine are substantially equivalent to predicate devices presently on the USA market and safety and effectiveness are well documented in the dental literature.
All pigments used are approved for alimentary or similar use and are Cadmium free.
The materials technical data (tests performed by NIOM Laboratory - Norway) are the following:
| Temporary.cold.v | Self-cure.dentine | |
|---|---|---|
| Flexural strength | 44N | 45N |
| Water absorption | 18,2-18,7 µg/mm³ | 23,1-25 µg/mm³ |
| Water solubility | 1,3-2,3 µg/mm³ | 0,2-1,7 µg/mm³ |
Temporary.cold.v and self-cure dentine are inherently safe when used according to the instructions for use.
Thev are for use only by dental practitioners; they are not intended for OTC use.
TECHNOLOGICAL CHARACTERISTICS (compared to the predicate device)
Temporary.cold.v and self-cure dentine have the same technological characteristics as the predicate devices since all the devices are complying with ISO 10477:1992 and have:
- . Same intended use
- Same polymers composition ●
- . Same working technique
NONCLINICAL TESTING AND CONCLUSIONS
Taking in account that:
- the products and their formulation and use are widely described and totally accepted in dentistry (McKabe, J., Applied Dental Materials, 7th, Blackwell Scientif. Publ .; Phillips, J., Skinner's Science of Dental Materials, Saunders Co .; Graig and Oth., Dental Materials, Properties and Manipulation, 6th, Mosby Publ.; O' Brien. W. J., Dental Materials, Proverties and Selection, Ouintessence Books):
- a large amount of literature has assessed the clinical liability of these product – types and their formulation, dedicating the attention to the denture base products
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but comprehending forcedly PMMA crown and bridges materials (about 10 articles registered on MedLine last year);
- these product types and their formulation are universal in the last fifty years manufacturing and clinical experience, counting for almost the totality of the not pre-formed temporary crowns and bridges in the world;
- the composition and philosophy of the evaluated products are exactly within what is described in most general literature;
- our company manufactures and sells these products, under these formulations and processes, since 1987 (last change) without any change, without any record of human incompatibility or clinical evidence of adverse effects, having totaled, directly or through connected companies or transferred technologies, about 8 tons of powders, corresponding to about :
we can assess these statements:
- the materials with which the products are manufactured, own a 50 years history of clinical research, testing and literature, which is largely sufficient not to request any further clinical research or testing;
- the products can then be considered clinically tested to be safe; -
- the clinical monitoring is effected independently by the general literature and it is largely sufficient not to request any further research or testing.
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem that resembles a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Monica Funai Quality and Regulatory Affairs MAJOR Prodotti Dentari S.p.A. Via Luigi Einaudi, 23, I-10024 Moncalieri (Torino) ITALY
DEC 0 9 2008
Re: K082700
Trade/Device Name: Temporary.Cold.V and Self-Cure Dentine Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: September 10, 2008 Received: September 15, 2008
Dear Ms. Funai:
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.
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Page 2 - Ms. Funai
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by i reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Smitee Y. Mclain Ons.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image is a logo for Major Dental. The logo is a black square with a white letter "M" inside. Below the letter "M" is the text "MAJOR DENTAL" in white letters. The word "MAJOR" is on the top line, and the word "DENTAL" is on the bottom line.
Indications for Use 11092700
510(k) Number (if known):
Device Name: temporary.cold.v and self-cure dentine
Indications for Use: temporary.cold.v and self-cure dentine are temporary cold-curing indirect crowns & bridges materials, Poly-methyImethacrylate based. Powder and liquid.
Intended use:
- Construction of temporary crowns and bridges -
- Immediate crown brush-modeling
- For gypsum or silicone key pouring technique -
- For rapidly repairing acrylic crowns and bridges -
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sua Russe
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
.10(k) Number: K05226