(118 days)
Not Found
No
The description focuses on the chemical composition and intended use of a cold-curing polymer for dental prostheses, with no mention of AI or ML.
No
The device is described as a cold-curing polymer for dental prostheses, used for repairing and rebasing dentures and as a temporary prosthesis. Its function is to fabricate or repair dental devices, not to treat a disease, injury, or condition in a therapeutic manner.
No
Explanation: The device is described as a cold-curing polymer for repairing and rebasing dental prostheses, which is a restorative and manufacturing function, not a diagnostic one.
No
The device is described as a cold-curing polymer (powder and liquid) for dental prosthesis repair and rebasing, 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: The intended use is for repairing and rebasing dental prostheses and for temporary prostheses. This is a direct application to a medical device (dental prosthesis) and not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description confirms it's a cold-curing polymer for dental prostheses, used for repair and rebasing. This aligns with a material used in the fabrication or repair of a medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, Major.Repair is a dental material used in the fabrication and repair of dental prostheses, which are medical devices, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid.
It is used to:
- repair and rebase prosthesis -
- temporary prosthesis -
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Major.repair is a cold-curing polymer for dental prosthesis. For reparing and rebasing dentures. Powder and liquid.
It can be used to:
- repair and rebase prosthesis .
- temporary prosthesis .
Major.repair is a self-curing polymer composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Major.repair is substantially equivalent to predicate denture base system 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.
Polymerized material technical data (test performed by NIOM Laboratory – Norway) are the following:
- . Flexural strength: 66.4 MPa
- Flexural modulus: 2217 MPa .
- Water absorption: 21,2 µg/mm3
- . Water solubility: 1.4 ug/mm3
- Residual monomer: 4,0 % .
Major.repair is inherently safe when used according to the instructions for use. It is for use only by dental practitioners; it is not intended for OTC use.
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)
Nonclinical Testing and Conclusions:
- 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, Properties and Selection, Quintessence Books).
- A large amount of literature has assessed the clinical liability of these product types and their formulation, dedicating special attention to the denture base products (about 12 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.
- The company manufactures and sells these products, under similar formulations and processes, since 1966, without any record of human incompatibility or clinical evidence of adverse effects, having totaled, directly or through connected companies or transferred technologies, more than 200 tons of powders in the last ten years.
Conclusions drawn:
- 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.
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
K082153 510(K) SUMMARY
NOV 2 5 2008
Image /page/0/Picture/2 description: The image shows a logo for Major Dental. The logo consists of a stylized letter "M" in white against a black background. Below the "M" are the words "MAJOR" and "DENTAL" stacked on top of each other. The text is in a simple, sans-serif font.
E.
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 | July 25, 2008 |
NAME OF DEVICE
| Proprietary name | major.repair |
|---|---|
| Common name | Cold cure polymer for dental prosthesis |
| Classification name | Denture relining, reparing, or rebasing resin |
| (21 CFR 872.3760, Product Code EBI) | |
| Predicate Devices | Probase Cold by Ivoclar Vivadent AG .........K913655 |
DESCRIPTION OF THE DEVICE
Major.repair is a cold-curing polymer for dental prosthesis. For reparing and rebasing dentures. Powder and liquid.
It can be used to:
- repair and rebase prosthesis .
- temporary prosthesis .
1
Major.repair is a self-curing polymer composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Major.repair is substantially equivalent to predicate denture base system 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.
Polymerized material technical data (test performed by NIOM Laboratory – Norway) are the following:
- . Flexural strength: 66.4 MPa
- Flexural modulus: 2217 MPa .
- Water absorption: 21,2 µg/mm3 �
- . Water solubility: 1.4 ug/mm3
- Residual monomer: 4,0 % .
Major.repair is inherently safe when used according to the instructions for use. It is for use only by dental practitioners; it is not intended for OTC use.
TECHNOLOGICAL CHARACTERISTICS (compared to the predicate device)
Major.repair has the same technological characteristics as the predicate devices since all the devices are complying with ISO 1567:1999 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, Properties and Selection, Quintessence Books);
- a large amount of literature has assessed the clinical liability of these product types and their formulation, dedicating special attention to the denture base products (about 12 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 similar formulations and processes, since 1966, without any record of human incompatibility or
2
clinical evidence of adverse effects, having totaled, directly or through connected companies or transferred technologies, more than 200 tons of powders in the last ten years;
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.
3
Image /page/3/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 an abstract symbol resembling an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2008
Ms. Monica Funai Ouality and Regulatory Affairs MAJOR Prodotti Dentari S.p.A. Via Luigi Einaudi, 23 I-10024 Moncalieri (Torino) ITALY
Re: K082153
Trade/Device Name: Major.Repair Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 4, 2008 Received: November 6, 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.
4
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 (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.
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 reference to premarket notification" (21CFR 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 vours.
Sultie Y. Maheen Oms
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
5
Image /page/5/Picture/0 description: The image shows the logo for Major Dental. The logo is a black square with a white letter "M" in the center. Below the square, the words "MAJOR DENTAL" are written in a sans-serif font. The word "MAJOR" is on top of the word "DENTAL".
Indications for Use
Ko8 2153 510(k) Number (if known):
Device Name: major.repair
Indications for Use: Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid.
It is used to:
- repair and rebase prosthesis -
- temporary prosthesis -
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Robert Betz DDS for Dr. Saun Lunner
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082153