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 -

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "temporary.cold.v and self-cure dentine" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Standard)	Reported Device Performance (temporary.cold.v)	Reported Device Performance (self-cure dentine)
Flexural strength	Not explicitly stated (implied by ISO 10477:1992 and predicate device comparison)	44N	45N
Water absorption	Not explicitly stated (implied by ISO 10477:1992 and predicate device comparison)	18.2-18.7 µg/mm³	23.1-25 µg/mm³
Water solubility	Not explicitly stated (implied by ISO 10477:1992 and predicate device comparison)	1.3-2.3 µg/mm³	0.2-1.7 µg/mm³

Note: The document explicitly states that "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." This indicates that the acceptance criteria are implicitly defined by compliance with ISO 10477:1992 and the performance of the predicate device (Trim® Plus by Harry J. Bosworth - K961199). The provided values for the device's technical data are presented as a direct comparison against the predicate, implying they meet the necessary performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "tests performed by NIOM Laboratory - Norway," but the specific number of samples tested for each metric (flexural strength, water absorption, water solubility) is not provided.
Data Provenance:
- Country of Origin: Norway (tests performed by NIOM Laboratory).
- Retrospective or Prospective: Not explicitly stated. Given the nature of laboratory material testing, it would generally be considered prospective testing of manufactured product samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is not applicable to this submission. The "ground truth" for the material's physical properties (flexural strength, water absorption, water solubility) is established through standardized laboratory testing following ISO norms, not human expert consensus.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods like "2+1" or "3+1" are relevant for expert review of subjective data (e.g., medical image interpretation), not for standardized laboratory measurements of material properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is relevant for diagnostic devices involving human interpretation, not for material properties.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This is not applicable to this device. This device is a material (temporary crown and bridge resin), not an algorithm or AI system. Its performance is inherent to its physical and chemical properties and how it's used by a dental practitioner.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance metrics (flexural strength, water absorption, water solubility) is based on standardized laboratory measurements according to established protocols (implied by compliance with ISO 10477:1992).

For the broader claim of safety and effectiveness, the document relies heavily on:

Extensive scientific literature: "safety and effectiveness are well documented in the dental literature," "a large amount of literature has assessed the clinical liability of these product – types and their formulation."
Historical clinical experience: "these product types and their formulation are universal in the last fifty years manufacturing and clinical experience," and the company's own 21 years of manufacturing experience "without any record of human incompatibility or clinical evidence of adverse effects."

8. Sample Size for the Training Set

This is not applicable as the device is a material, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is a material, not an AI/ML algorithm.

Summary

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K082700

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, 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	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

E-2

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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.

E-3

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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

Page 1 of 1

D-3

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

.10(k) Number: K05226

Regulation Number and Section

§ 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.