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 -

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the major.repair device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for major.repair are implicitly derived from the ISO 1567:1999 standard for "Dentistry – Polymer-based restorative materials," as the device is stated to comply with this standard. The reported performance data points from the NIOM Laboratory (Norway) are presented as direct measurements against relevant physical properties.

Acceptance Criteria (Derived from ISO 1567:1999 Compliance)	Reported Device Performance (major.repair)
Flexural strength: (ISO 1567:1999 standard value)	66.4 MPa
Flexural modulus: (ISO 1567:1999 standard value)	2217 MPa
Water absorption: (ISO 1567:1999 standard value)	21.2 µg/mm³
Water solubility: (ISO 1567:1999 standard value)	1.4 µg/mm³
Residual monomer: (ISO 1567:1999 standard value)	4.0 %

Note: The exact numerical acceptance values from ISO 1567:1999 are not explicitly stated in the document, but the fact that the device complies with the standard implies its performance meets or exceeds those values. The reported performance data for major.repair are the values determined from testing.

Study Information

The 510(k) summary for major.repair does not describe a new, standalone clinical study or comparative effectiveness study in the traditional sense, but rather relies on a literature review and historical data.

Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of a new, standalone study. The "test set" here refers to the samples used in the physical properties testing, but the sample size for those tests is not specified.
- Data provenance: For the physical properties data, the testing was performed by NIOM Laboratory – Norway. For clinical aspects, the provenance is a vast body of existing dental literature, clinical experience with similar products, and the manufacturer's own historical sales data since 1966. This is a retrospective approach based on existing information and general scientific acceptance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the "ground truth" for the physical properties was established through standardized laboratory testing (NIOM). For the broader clinical "ground truth," it relies on the consensus and findings published in the extensive dental literature cited (e.g., McKabe, Phillips, Graig, O' Brien) and decades of clinical experience. No specific individual experts are identified as establishing a ground truth for a new test set.
Adjudication method for the test set:
- Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the nature of the evidence provided for this dental material.
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:
- No MRMC comparative effectiveness study was mentioned or performed. This device is a dental material, not an AI-assisted diagnostic or treatment planning tool.
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 physical property tests are standalone measurements of the material itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical properties: Standardized laboratory measurements and compliance with ISO 1567:1999.
- For clinical safety and effectiveness: Broad expert consensus from extensive dental literature, historical clinical experience with similar product types, and the manufacturer's long-term sales history with no reported adverse effects. This is a combination of expert consensus derived from literature and real-world outcomes data over a long period.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm. The product's formulation and performance are based on established dental science and manufacturing processes.
How the ground truth for the training set was established:
- Not applicable due to the absence of a "training set." The understanding of the material's properties and clinical behavior is derived from scientific principles, material characterization, and historical data as described above.

Summary

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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.

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, 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	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 .

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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

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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.

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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.

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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 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

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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

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.