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 -

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.

AI/ML Overview

The provided document describes the 510(k) premarket notification for Major.base 20, a denture base material. The submission relies on substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the typical sense of a diagnostic or therapeutic device. Therefore, some of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of an algorithm or diagnostic performance, is not directly applicable or available in the provided text.

However, I can extract information related to the device's technical specifications and how its performance was assessed in the context of demonstrating substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The acceptance criteria for Major.base 20 are implicitly defined by its substantial equivalence to predicate devices (Paladon® 65 and Probase Hot) and compliance with relevant ISO/ADA standards. The "device performance" reported is based on technical data of the polymerized material.

Acceptance Criteria (Standard / Predicate Equivalence)	Reported Device Performance (Major.base 20)
Compliance with ISO 1567:1999 or ADA/ANSI 12:2002 (Adoption of the ISO 1567:1999) for denture relining, repairing, or rebasing resin.	"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)"
Specific Technical Parameters (Implied from Predicate/Standard Compliance):
Flexural strength (no specific numerical criterion given, but implied to be comparable to predicates/standard)	78 MPa
Flexural modulus (no specific numerical criterion given, but implied to be comparable to predicates/standard)	2390 MPa
Water absorption (no specific numerical criterion given, but implied to be comparable to predicates/standard)	22.0 µg/mm³
Water solubility (no specific numerical criterion given, but implied to be comparable to predicates/standard)	1.5 µg/mm³
Residual monomer (no specific numerical criterion given, but implied to be comparable to predicates/standard)	1.8 %
Same intended use as predicate devices.	"Same intended use"
Same polymers composition as predicate devices.	"Same polymers composition"
Same working technique as predicate devices.	"Same working technique"
Historically established safety and effectiveness (demonstrated by widespread use of similar product types over 50 years).	"inherently safe when used according to the instructions for use." "50 years history of clinical research, testing and literature" without records of human incompatibility or adverse effects.

Study Information (Based on the 510(k) Submission)

For this type of device (denture base material), the "study" is primarily a nonclinical testing and comparison to existing, legally marketed predicate devices and reliance on extensive historical data and scientific literature.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a diagnostic AI study. The technical data provided (Flexural strength, modulus, water absorption, solubility, residual monomer) are physical properties measured on the material itself. The document does not specify the number of samples used for these tests.
- Data Provenance: The technical tests were "performed by NIOM Laboratory - Norway." The broader "data" for substantial equivalence relies on a vast body of dental literature and historical clinical experience over 50 years worldwide ("universal in the last fifty years manufacturing and clinical experience").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a material, not one requiring expert human interpretation for ground truth or diagnostic assessment. The "ground truth" for the material's properties would be defined by the standardized testing protocols themselves.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a diagnostic interpretation scenario requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the reported performance metrics (flexural strength, etc.) is the results of standardized laboratory physical property testing.
- For the overall safety and effectiveness claim, the "ground truth" is established through extensive scientific literature, historical clinical experience (over 50 years with similar products), and compliance with international standards (ISO 1567:1999 / ADA/ANSI 12:2002), along with a lack of adverse event records from the manufacturer's long history.
The sample size for the training set
- Not applicable. This is not a machine learning device that requires a "training set."
How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.

Summary

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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, 23I-10024 Moncalieri (TO)ITALY
Facility registrationnumber	4565
Contact person	Monica Funai
Phone number	+39.011.6400.211
Fax number	+39.011.6400.222
e-mail	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. K901789Probase 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

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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);

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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

Regulation Number and Section

§ 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.