(507 days)
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.
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.
This submission is for a root canal sealer, MM-SEAL, a medical device, and therefore does not have acceptance criteria or study data of the type requested in the prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC study, standalone algorithm performance, or ground truth types related to AI/ML device performance). The document provided is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device, not a study report for an AI/ML system.
The performance section of the document states:
- "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..."
- "...the biological evaluation has been done following ISO 10993-1 Biological evaluation of medical devices."
The submission concludes that MM-SEAL is substantially equivalent to its predicate device (ADSEAL K042769) based on identical manufacturer, intended use, chemical composition, physical properties, manufacturing process, method of application, and similar user manual and packaging.
Since this device is not an AI/ML product, the questions regarding acceptance criteria, study details, and data provenance for such technologies are not applicable here.
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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 : +33 (0)3 81 54 42 42 Fax : +33 (0)3 81 54 42 49
Contact Person
Philippe Conche 5-12 rue du tunnel 25006 BESANCON CEDEX FRANCE Tel : +33 (0)3 81 54 42 29 Fax : +33 (0)3 81 54 42 49 Email : philippe.conche@micro-mega.com
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 184 199-100- | 17908 | Manufacturer |
|---|---|---|
| K042769 | ADSEALMENSELERA 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 করMHICO.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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Document A103 Page A103.2
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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'
Document Al02 Page Al02.1
§ 872.3820 Root canal filling resin.
(a)
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.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.