(98 days)
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No
The document describes a traditional denture base polymer and makes no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a denture base polymer used to create dental prostheses, which replace missing teeth but do not treat a disease.
No
Explanation: The device is described as a denture base polymer used for dental prostheses, particularly for total, partial, and clasp dentures. Its function is to form a physical part of a prosthesis, not to diagnose a medical condition or disease.
No
The device description clearly states it is a denture base polymer, 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 creating dental prostheses (dentures), which are physical devices used in the mouth. This is a mechanical or structural application, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description confirms it's a polymer material used to construct dentures. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, Major.Base 20 is a dental material used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: - dental prosthesis - partial prosthesis - clasp prosthesis -
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Major.base 20 is a denture base, poly(methyl methacrylate)-based polymers for dental prosthesis. It can be used for: - Total prosthesis . - Partial prosthesis . - Clasp dentures e Major base 20 is a heat cure denture base material composed of a poly-methylmethacrylate polymer powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Polymerized material technical data (test performed by NIOM Laboratory - Norway) are the following: - . Flexural strength: 78 MPa - Flexural modulus: 2390 MPa . - Water absorption: 22,0 µg/mm3 . - Water solubility: 1,5 µg/mm3 . - Residual monomer: 1,8 % . Major.base 20 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength: 78 MPa Flexural modulus: 2390 MPa Water absorption: 22,0 µg/mm3 Water solubility: 1,5 µg/mm3 Residual monomer: 1,8 %
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.
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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).
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§ 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
Kof1884
OCT 0 8 2008
510(K) SUMMARY E.
Image /page/0/Picture/3 description: The image is a logo for Major Dental. The logo is a large, stylized letter "M" in white against a black background. Below the "M" are the words "MAJOR" and "DENTAL" stacked on top of each other, also in white.
MAJOR Prodotti Dentari S.p.A. Via Luigi Einaudi, 23, 10024 Moncalieri (TO) - ITALY 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 | June 26, 2008 |
NAME OF DEVICE
| Proprietary name | Major.base 20 |
|---|---|
| Common name | Denture base material |
| Classification name | Denture relining, reparing, or rebasing resin |
| (21 CFR 872.3760, Product Code EBI) | |
| Predicate Devices | Paladon® 65 by Heraeus Kulzer GmbH & Co. K901789 |
| Probase Hot by Ivoclar Vivadent AG K913655 |
DESCRIPTION OF THE DEVICE
Major.base 20 is a denture base, poly(methyl methacrylate)-based polymers for dental prosthesis. It can be used for:
- Total prosthesis .
- Partial prosthesis .
- Clasp dentures e
1
Major base 20 is a heat cure denture base material composed of a poly-methylmethacrylate polymer powder and a liquid consisting of methylmethacrylate and other ingredients solution.
Major.base 20 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: 78 MPa
- Flexural modulus: 2390 MPa .
- Water absorption: 22,0 µg/mm3 .
- Water solubility: 1,5 µg/mm3 .
- Residual monomer: 1,8 % .
Major.base 20 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 base 20 has the same technological characteristics as the predicate devices since all the devices are complying with ISO 1567:1999 or ADA/ANSI 12:2002 (Adoption of the ISO 1567:1999) and have:
- Same intended use .
- Same polymers composition .
- Same working technique .
Finally our laboratory experience in using the listed devices is that you cannot find substantial differences: they are equivalent to major.base 20.
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 the attention to the denture base (see for instance articles registered on MedLine);
2
- these product types and their formulation are universal in the last fifty years manufacturing and clinical experience, counting for almost the totality of the denture bases 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 clinical evidence of adverse effects, having totaled, directly or through connected companies or transferred technologies, more than 150 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 피 clinical research, testing and literature, which is largely sufficient not to request any further clinical research or testing;
- 트 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 logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
Ms. Monica Funai Ouality and Regulatory Affairs MAJOR Prodotti Dentari S.p.A. Via Luigi Einaudi 23, Moncalieri (Torino) ITALY I-10024
Re: K081884
Trade/Device Name: Major.Base 20 Regulation Number: 21 CFR 872.3760 Regulation Name: Denture, Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI 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 Eederal 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 (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 yours,
Klemule Lendner forll
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/1 description: The image shows a logo with a stylized letter "M" at the top, which appears to be a graphical representation. Below the "M", the word "MAJOR" is printed in a bold, sans-serif font. The word "DENTAL" is printed below "MAJOR", also in a bold, sans-serif font. The logo is set against a black background, with the letter and text appearing in white.
Indications for Use
510(k) Number (if known):
Device Name: major.base 20
Indications for Use: Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid.
It is used for:
- dental prosthesis -
- partial prosthesis
- clasp 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
Susan Reese
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K051884