MM-SEAL

K123276 · Micro-Mega Societe Anonyme · KIF · Mar 10, 2014 · Dental

Device Facts

• Record ID: K123276
• Device Name: MM-SEAL
• Applicant: Micro-Mega Societe Anonyme
• Product Code: KIF · Dental
• Decision Date: Mar 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments. MM-SEAL is intended for use by qualified healthcare personnel trained in its use.

Device Story

MM-SEAL is a biocompatible root canal sealer supplied in a dual-syringe delivery system. It is used by dental professionals during endodontic procedures to fill root canals. The clinician mixes the two components on a mixing plate for 15-20 seconds until a creamy, homogeneous consistency is achieved. The sealer is applied to dried canal walls, ensuring no air bubbles are formed, and used to coat gutta-percha points. These points are then inserted into the canal and condensed. The device is compatible with thermoplasticized gutta-percha or gutta-percha coated obturator techniques. By sealing the root canal space, the device aids in the obturation process, supporting successful endodontic treatment outcomes.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 6876 (Dental root canal sealing materials). Biological safety evaluated per ISO 10993-1. Risk analysis conducted per ISO 14971.

Technological Characteristics

Dual-syringe delivery system. Biocompatible root canal sealing resin. Complies with ISO 6876 for sealing materials, ISO 10993-1 for biological evaluation, and ISO 14971 for risk management.

Indications for Use

Indicated for filling root canals in conjunction with gutta percha points during endodontic treatments. Intended for use by trained healthcare personnel.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• ADSEAL (K042769)

Submission Summary (Full Text)

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# MAR 1 0 2014

## SECTION 5: 510(k) Summary

### Submitter

Micro-Mega Société Anonyme 5 - 12 rue du tunnel 25006 BESANCON CEDEX FRANCE Tel : [phone] Fax : [phone]

### Contact Person

Philippe Conche 5-12 rue du tunnel 25006 BESANCON CEDEX FRANCE Tel : [phone] Fax : [phone] Email : [e-mail]

### Date Prepared

September, 2012, corrected for additional information in November 2013

### Device Information

Trade name: MM-SEAL Common name: Root canal sealer Classification Name: Root Canal Filling Resin Review Panel: Dental Product Code: KIF Device Class: II

### Devices to which substantial equivalence is claimed:

| 1974, PA 184 199<br>-100- | 17908 | Manufacturer |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K042769 | ADSEAL<br>MENSELERA FLORICAL STERNETA A CONSULAR CONSULTATION CONSULTATION CONSULTATION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTI | বিশ্ববিদ্যালয় বিশ্ববিদ্যালয় প্রতিষ্ঠান করে তার প্রকল্প করে পারে পারে পারে পারে। এরপর পর পর পর পর পর পর পর পর পর পর পর পর পর পর পর পর পর করে আর করে পারে করে পারে করে আর কর<br>MHI<br>CO.ITT |

### Indications for Use:

The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.

MM-SEAL is intended for use by qualified healthcare personnel trained in its use.

Image /page/0/Picture/16 description: The image shows a logo with the letters "MM" in a bold, blocky font. The word "MICRO" is written below the left "M", and the word "MEGA" is written below the right "M". There is a registered trademark symbol to the right of the top right corner of the right "M". The logo appears to be for a company or product called "Micro Mega".

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### Device Description

The MM-SEAL is a biocompatible root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.

The device consists of two component (dual syringe) which are mixed before the use in the dental canal, onto a mixing plate with a spatula for 15-20 seconds or until the mixture become creamy and homogeneous.

Application: Thoroughly dry canals walls and apply MM-SEAL, avoiding the formation of air bubbles. Do not exceed the apical limit. Dip the tips of dry, disinfected Gutta-percha points in MM-SEAL. Insert one or more points in the root canal and condense the Gutta-percha. MM-SEAL can be used with thermoplasticized gutta-percha or gutta-percha coated obturator techniques.

MM-SEAL should not be used expiry date.

MM-SEAL is intended for use by qualified healthcare personnel trained in it use.

### Performance

The performance of MM-SEAL has been evaluated following the standard ISO 6876, Dental root canal sealing materials, the risk analysis has been conducted following ISO 14971 (see appendix 4), the biological evaluation has been done following ISO 10993-1 Biological evaluation of medical devices.

### Compararison with the predicate device

The MM-SEAL has the same manufacturer (META BIOMED CO) than its predicate device (ADSEAL K042769) and the same intended use, the same chemical composition, the same physical properties, the same manufacturing process, the same method of application, a very similar user manal and a similar packaging as its predicate device ADSEAL (META BIOMED CO). The detailed comparison is done is section 12.

### Conclusion

The MM-SEAL was compared against its predicate, and was found to be substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2014

Micro-Mega Societe Anonyme Mr. Philippe Conche Regulatory Affairs Manager 5 - 12 rue du tunnel 25006 Besancon Cedex FRANCE

Re: K123276

Trade/Device Name: MM-SEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 6, 2014 Received: February 10, 2014

### Dear Mr. Conche:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Conche

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Image /page/3/Picture/8 description: The image shows the text "Erin - 80th -S". The text is written in a bold, sans-serif font. The word "Erin" is followed by a hyphen, then the number "80th", and finally another hyphen followed by the letter "S".

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows a logo with the letters "MM" stacked on top of each other. Below the letters, the words "MICRO MEGA" are written. A circled "R" trademark symbol is located in the upper right corner of the logo. The logo appears to be a company or brand identifier.

## SECTION 4: Indications for Use

510(k) Number: K123276

Device Name:

MM-SEAL - Root Canal Sealer

Indications for Use:

The MM-SEAL is a root canal seater packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments.

MM-SEAL is intended for use by qualified healthcare personnel trained in its use.

. AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

のお気になると、その他のお店になる。

Mary S. Runner -S
Susan Run DDS, MA 2014.03.10
16:03:20-04'00'

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