(264 days)
No
The device description and performance studies focus on the material properties and biological compatibility of a root canal sealant, with no mention of AI or ML.
No
The device is described as a material for permanent sealing of a root canal, which is a dental procedure. While it is used in a medical context, it functions as a sealer, not a device that generates therapeutic effects such as stimulating a biological response or providing treatment that alleviates a disease.
No
Justification: The device's intended use is for "Permanent sealing of root canal," which is a treatment or therapeutic function, not a diagnostic one. The description also mentions it is a "premixed ready-to-use composition which requires the presence of water to set and harden," indicating it's a material used for treatment rather than diagnosis.
No
The device description clearly states it is a "premixed ready-to use composition" contained in a "plastic syringe" with a "plunger, disposable tips, and a holder," indicating it is a physical substance and delivery system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Permanent sealing of root canal." This is a therapeutic procedure performed directly on a patient's anatomy (the root canal).
- Device Description: The device is a material used to fill and seal the root canal. It is applied directly to the patient.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device is not used for such testing.
- Anatomical Site: The anatomical site is the "root canal," which is part of the patient's body.
IVD devices are used for diagnosis or monitoring, typically by analyzing samples in a laboratory setting. This device is a therapeutic material used in a dental procedure.
N/A
Intended Use / Indications for Use
Permanent sealing of root canal
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder. We offer the following three types of package configuration. The raw materials including chemical composition of the Well-Root ST Type C (E) and Well-Root ST Type F (for sample) are the same. The only difference between the types are the net weight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 201 Subpart D) / Hospital
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)
The following testing was conducted on our subject device:
- Shelf Life: Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)
- ISO 6876: Flow, Film Thickness, Solubility and disintegration, Radio-opacity, Working time
- ISO 10993-5 (Cytotoxicity), 10993-10 (Sensitivity-LLNA, GPMT), 10993-11 (Acute systemic Totoxicity), ISO 10993-3 (Genotoxicity-Bacterial reverse mutation(Ames), In vitro mammalian chromosomal aberration), ISO10993-6 (Implantation)
The subject device is different from the predicate devices in shelf life and raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate devices.
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
December 20, 2017
Vericom Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc 690 Roosevelt Irvine, California 92620
Re: K170950
Trade/Device Name: Well-Root ST Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: November 20, 2017 Received: November 21, 2017
Dear Priscilla Chung:
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.
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 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);
1
Page 2 - Priscilla Chung
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Well-Root™ ST
Indications for Use (Describe)
Permanent sealing of root canal
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ----------------------------------------------------------- | ---------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K170950)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 12/15/2017
1. Applicant / Submitter:
Vericom Co., Ltd. 48,Toegyegongdan 1-Gil, Chuncheon-Si, Gangwon-Do, 200-944, Republic of Korea Tel: +82-31-441-2881 Fax: +82-31-441-2883
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
- Trade Name: Well-Root™ ST
- Classification Name: Root Canal Filling Resin
- Classification regulation: 21CFR 872.3820
- Product Code: KIF
4. Predicate Device:
- Primary Predicate Device: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International
- . Reference Device: iRoot SP (K080917) by Innovative BioCeramix, Inc.
5. Description:
Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder. We offer the following three types of package configuration. The raw materials including chemical composition of the Well-Root ST Type C (E) and Well-Root ST Type F (for sample) are the same. The only difference between the types are the net weight.
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| Package Type Name | Package Contents |
|---|---|
| Well-Root ST Type C | 2g Syringe 1ea, Disposable Tip 20ea, Holder 1ea |
| Well-Root ST Type E | 2g Syringe 1ea, Disposable Tip 15ea, Holder 1ea |
| Well-Root ST Type F(for sample) | 0.5g Syringe 1ea, Disposable Tip 3ea, Holder 1ea |
6. Indications for use:
Permanent sealing of root canal
7. Comparison to the Cleared Device
Well-Root™ ST has the same intended use as the predicate devices: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International and iRoot SP (K080917) by Innovative BioCeramix, Inc. The indication of the statement of the subject device is more simplified than the predicate devices but it does not contain new indications.
All of the devices confirm to ISO 6876 and are provided non-sterile. Both Well-Root™ ST and the iRoot SP (K080917) premixed ready-to-use injectable white hydraulic cement paste.
The difference between the Well-Root™ ST and the primary predicate device (AH PLUS ROOT CANAL SEALER) are delivery form and setting time. However, the differences do not affect to safety and effectiveness of product considerably. Delivery forms are just one of the attributes medical devices have for convenience of use. For the setting time, the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance.
We identified the reference device (iRoot SP) for similar raw materials and delivery form premixed ready-to use injectable paste. Well-Root ST is composed of lubricants, radiopaque agent and thickening agents as the reference device. Main materials, Calcium aluminosilicate compound of Well-Root ST is similar to Calcium silicate of the reference device. Also zirconium oxide as radiopaque agent is contained in both subject device and the reference device.
The results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness. Therefore, it is concluded that Well-Root™ ST is substantially equivalent to the predicate device.
| | Subject Device | Primary Predicate
Device | Reference Device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Well-Root™ ST | AH PLUS ROOT
CANAL SEALER | iRoot SP |
| Manufacturer | VERICOM CO., LTD. | Dentsply International | Innovative BioCeramix,
Inc. |
| 510K Number | K170950 | K960548 | K080917 |
| Product Code | KIF | KIF | KIF |
| | | | |
| Indications for Use | Permanent sealing of
root canal | AH PLUS Root Canal
Sealer is used for
permanent sealing of root
canals following
established endodontic
procedures. | • Permanent obturation of
the root canal following
vital pulp-extirpation
• Permanent obturation of
the root canal following
removal of infected or
necrotic pulp and
placement of intracanal
dressings.
iRoot SP is suitable for use
in the single cone and
lateral condensation
technique. |
| | Insoluble, radiopaque
material based on a
calcium aluminosilicate
compound containing: | Epoxy resin paste(Paste
A) and the amine-
containing paste(Paste B)
containing: | Insoluble, radiopaque
material based on a
calcium silicate compound
containing: |
| Raw materials | Lubricants
Zirconium oxide
Calcium sulfate
dihydrate
Titanium dioxide
Inorganic glass(Calcium
sodium phosphosilicate) | Paste A
Bisphenol-A epoxy resin
Bisphenol-F epoxy resin
Calcium tungstate
Zirconium oxide
Silica
Iron oxide pigments | Thickening agent
Zirconium oxide
Filler |
| | Calcium aluminosilicate
compound | Paste B
Dibenzyldiamine
Aminoadamantane
Tricyclodecane-diamine
Calcium tungstate
Zirconium oxide
Silica
Silicone oil | Calcium phosphate
monobasic
Calcium hydroxide
Calcium
silicates(Tricalcium
silicate, Dicalcium
silicate) |
| Principle of operation | Well-Root™ ST is a
convenient premixed
ready-to-use injectable
white hydraulic cement
paste developed for
permanent root canal
filling and sealing
applications. Well-
Root™ ST is an
insoluble, radiopaque
material which sets and
hardens with moisture
providing from dentin
tubules during hydration
reaction. Well-Root™
ST is packaged in a pre-
loaded syringe and is
supplied with disposable
tips. | AH Plus Root Canal
Sealer consists of two
components, the epoxy
resin paste(Paste A) and
the amine-containing
paste(Paste B) portions
which are mixed prior to
insertion into the root
canal.
AH Plus Root Canal
Sealer is two-component
systems that react via an
epoxide/amine chemical
reaction to cause setting. | iRoot SP is a convenient
premixed ready-to-use
injectable white hydraulic
cement paste developed
for permanent root canal
filling and sealing
applications. iRoot SP is
an insoluble, radiopaque
material which requires
the presence of water to
set and harden. iRoot SP is
packaged in a pre-loaded
syringe and is supplied
with disposable tips. |
| Performance
Standard
Conformance | Conformed to ISO 6876 | Conformed to ISO 6876 | Conformed to ISO 6876 |
| Biocompatibility | Yes | Yes | Yes |
| Use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital |
| Delivery Forms | Single paste | Manual mixing of paste
A and paste B | Single paste |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
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6
8. Performance Data
The following testing was conducted on our subject device:
- . Shelf Life: Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)
- ISO 6876: Flow, Film Thickness, Solubility and disintegration, Radio-opacity, Working time
- ISO 10993-5 (Cytotoxicity), 10993-10 (Sensitivity-LLNA, GPMT), 10993-11 (Acute ● systemic Totoxicity), ISO 10993-3 (Genotoxicity-Bacterial reverse mutation(Ames), In vitro mammalian chromosomal aberration), ISO10993-6 (Implantation)
The subject device is different from the predicate devices in shelf life and raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate devices.
9. Conclusion
Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate devices.