(89 days)
No
The summary describes a material and associated tools for root canal obturation, with no mention of AI or ML capabilities.
Yes
The device is used for permanent obturation of root canals after treatment of pulpal gangrene, which is a therapeutic intervention.
No
Explanation: The device is described as a material for permanent obturation of root canals, meaning it is used for filling and sealing, not for diagnosis.
No
The device description explicitly states it is a paste and includes physical components like a syringe, tips, spatula, and mixing pads, indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for permanent obturation and temporary filling of root canals. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a material (paste) for filling root canals. It is applied directly to the anatomical site (root canals).
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes.
IVD devices are used to test samples (like blood, urine, tissue) taken from the body to diagnose or monitor a medical condition. This device is used within the body for treatment.
N/A
Intended Use / Indications for Use
GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.
GuttaSil is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
Product codes (comma separated list FDA assigned to the subject device)
KIF, EKM
Device Description
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Performance tests such as Appearance, Weight, Packaging, Flow, Working Time, Setting Time, Film Thickness, Solubility, Radio-opacity according to ISO 6876:2012.
- Shelf Life test: ISO 6876 tests (appearance, package, flow, setting time, and Solubility)
Key Results: Conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2019
Meta Biomed Co., Ltd. April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K190510
Trade/Device Name: GuttaSil Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EKM Dated: February 20, 2019 Received: March 1, 2019
Dear April Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190510
Device Name GuttaSil
Indications for Use (Describe)
GuttaSil is a material for permanent obturation of root canals after treatment of pulpal gangrene and temporary filling of the canal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Submitter
META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983
Device Information
- Trade Name: GuttaSil ●
- . Classification Name: resin, root canal filling
- Primary Product Code: KIF
- . Secondary Product Code: EKM
- Panel: Dental
- Regulation Number: 21 CFR 872.3820
- Device Class: Class II
- Date prepared: 05/09/2019
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
K032662, GUTTAFLOW manufactured by COLTENE/WHALEDENT GMBH & CO. KG ●
Reference Devices -
K042769, ADSEAL ROOT CANAL SEALER manufactured by META BIOMED CO., LTD. ●
-
K171449, METACEM manufactured by META BIOMED CO., LTD.
Device Description
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
4
Indication for Use
GuttaSil is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
Non-clinical Testing
The following testing was conducted on our subject device:
- Biocompatibility Tests according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, . ISO 10993-11:2006.
- . Performance tests such as Appearance, Weight, Packaging, Flow, Working Time, Setting Time, Film Thickness, Solubility, Radio-opacity according to ISO 6876:2012.
- Shelf Life test: ISO 6876 tests (appearance, package, flow, setting time, and Solubility) ●
Summary of Technological Characteristics:
The subject device and the predicate device have the same intended use and have the similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.
The subject device is different from the predicate devices in raw materials, however, both devices are silicone based and the test results provided in this submission supports that it is substantially equivalent to the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | Meta Biomed Co., Ltd. | GuttaFlow |
| Device Name | GuttaSil | Coltene/Whaledent GMbH & Company KG |
| 510(k) Number | NA | K032662 |
| Classification Name | resin, root canal filling | resin, root canal filling |
| Product Code | KIF, EKM | KIF, EKM |
| Regulation Number | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications for use | GuttaSil is a material for permanent | |
| obturation of root canals after vital | ||
| extirpation and after treatment of pulpal | ||
| gangrene and temporary filling of the | ||
| canal. | GuttaFlow is a material for permanent | |
| obturation of root canals after vital | ||
| extirpation and after treatment of pulpal | ||
| gangrene and temporary filling of the canal. |
5
| Raw Material | Gutta-percha powder
polydimethylsiloxane
platinum catalyst
zirconium dioxide
micro-silver (preservative)
colouring. | Gutta-percha powder
polydimethylsiloxane
platinum catalyst
zirconium dioxide
micro-silver(preservative)
colouring |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | a cold flowable filling system for root canals. | a cold flowable filling system for root canals |
| Performance Standard
Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes |
| Delivery Forms | Single Paste | Single Paste |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 2 years |
Conclusion:
Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.