(426 days)
Not Found
No
The summary describes a chemical root canal sealer and its performance based on standard material property tests, with no mention of AI/ML, image processing, or data-driven algorithms.
No.
This device is a root canal sealer used for permanent sealing of root canals, which is a restorative material used during a dental procedure, not a therapeutic device.
No
The device, DIA-PROSEAL, is described as a permanent sealing material for root canals. Its intended use is to treat a condition by sealing and not to diagnose a condition. The performance studies also focus on material properties like setting time, solubility, and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a "two-component system that react via an epoxide/amine chemical reaction to case setting," indicating it is a physical substance, not software. The performance studies also focus on material properties like setting time, solubility, and flow, which are relevant to a physical sealer.
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 sealing of root canals in secondary dentition with gutta percha points." This is a therapeutic procedure performed directly on the patient's body (in the root canal).
- Device Description: It's a "two-component systems that react via an epoxide/amine chemical reaction to case setting." This describes a material used for sealing, not for analyzing a sample from the body.
- Anatomical Site: The anatomical site is "root canals in secondary dentition," which is within the patient's body.
- Performance Studies: The performance studies listed (ISO 7405, ISO 10993 series, ISO 6876) are related to the biocompatibility and physical properties of a material intended for implantation or contact with tissue, not for diagnostic testing of a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals in secondary dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) / Prescription/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)
Non-Clinical Performance Data: This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following standards:
ISO 7405:2008
ISO 10993-1:2009
ISO 10993-3:2014 (Relevant Tests: Bacterial Reverse mutation)
ISO 10993-5:2009 (Relevant Tests: Cytotoxicity)
ISO 10993-10:2010 (Relevant Tests: Sensitization, Irritation/Intracutaneous reactivity)
ISO 10993-11:2017 (Relevant Tests: Acute systemic toxicity)
ISO 6876:2012 (Relevant Tests: Setting time, Film Thickness, Radio-opacity, Solubility, Flow)
Clinical Performance Data: No clinical data was collected or provided to support substantial equivalence between the subject and 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains 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.
September 26, 2019
Diadent Group International Myung Sub Kim Quality Assurance Manager 16. Osongsaengmyeong 4-ro. Osong-eup, Heungdeok-gu Cheongji-si, 28161 KOREA
Re: K182009
Trade/Device Name: DIA-PROSEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 30, 2019 Received: August 30, 2019
Dear Myung Sub Kim:
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Srinivas Nandkumar, PhD Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DIA-PROSEAL
Indications for Use (Describe)
DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.
Type of Use (Select one or both, as applicable) > 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
510(k) Summary
5.0 Application Information
| Date Prepared: | 26th Sep, 2019 |
|---|---|
| Company Name and | |
| Address: | DiaDent Group International |
| 16, Osongsaengmyeong 4-ro, Osong-eup, Heundeok-gu, Cheongju- | |
| si, Chungcheongbuk-do, 28161, Republic of Korea | |
| Contact Person: | Myung Sub Kim |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
5.1 Device Information
| Device Type: | Root Canal Filling Resin |
|---|---|
| Regulation Description: | Root Canal Filling Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
| Device Name: | DIA-PROSEAL |
5.2 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| 510(k) Number: | K960548 |
|---|---|
| Applicant: | Dentsply International |
| Device Name: | AH Plus Root Canal Sealer |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
5.3 Device Description
DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting.
5.4 Intended Use/Indications for Use
- DIA-PROSEAL is used for permanent sealing of root canals in secondary dentition with gutta percha points.
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5.5 Technological Characteristics
This device compares to the legally marketed devices as follows:
| Subject Device | Primary Predicate Device | Discuss | |
|---|---|---|---|
| Product name | Dia-ProSeal | AH Plus | |
| Manufacturer | DiaDent Group International | Dentsply | |
| 510K Number | K182009 | K960548 | |
| Product Code | KIF | KIF | |
| Intended use | DIA-PROSEAL is used for permanent | ||
| sealing of root canals in secondary | |||
| dentition with gutta percha points. | AH Plus Root Canal Sealer is used for | ||
| permanent sealing of root canals | |||
| following established endodontic | |||
| procedures. | Equivalent | ||
| Image | Image: Dia-Proseal product packaging | Image: AH Plus product packaging | |
| Main | |||
| ingredient | Base | ||
| Bisphenol A epoxy resin | |||
| Bisphenol F epoxy resin | |||
| Zirconium dioxide | |||
| Iron oxide | |||
| silica | |||
| Calcium tungstate |
Catalyst
amine-containing paste | Paste A
Bisphenol A epoxy resin
Bisphenol F epoxy resin
zirconium oxide
Iron oxide Pigments
silica
Calcium tungstate
Paste B
amine-containing paste | The main
ingredients
of AH Plus
and of Dia-
Proseal
are similar.
They are
both two-
component
system
that use
epoxide/
amine
reaction to
cause
setting. |
| Resin Sealer
Type | Epoxy resin based sealers | Epoxy resin based sealers | equivalent |
| Device
description | DiaProSeal Root Canal Sealer consists
of two components, the epoxy resin
paste(Base) and the amine-containing
paste(Catalyst) portions which are
mixed prior to insertion into the root
canal.
DiaProSeal Root Canal Sealer is two-
component systems that react via an
epoxide/amine chemical reaction to
cause setting. | AH Plus Root Canal sealer is a two-
component paste: paste root canal
sealer based on epoxy-amine rein
chemistry. This is easy-to-mix sealer
adapts closely to the walls of the
prepared root canal and provides
outstanding long-term dimensional
stability with minimal shrinkage upon
setting.
The final product consists of two
components, the epoxy resin
paste(PasteA) and the amine-
containing paste(PasteB) portions
which are mixed prior to insertion into
the root canal | equivalent |
| Direction
for | Application Method | Preparation | equivalent |
| | | | |
| Use | 1. Isolate the site with rubber dam.
Prepare and shape the root canal. | 1. Prior to the application of the | |
| | 2. Remove any debris inside the root
canal. Disinfect and clean the root canal
thoroughly with Sodium Hypochlorite or
EDTA solution and dry it completely. | material prepare, clean, and dry the
root canals to be filled using state-of-
the-art endodontic techniques. | |
| | 3) Open the safety cap of DIAPROSEAL
and squeeze out the vase material
(yellow) and the catalyst material(white)
in 1:1 ratio from the dual syringe onto a
mixing pad. (Due to the different
viscosity of the vase material and the
catalyst material, they may be dispensed
at a different speed). | Dosage and mixing | |
| | 4. Using a mixing stick or metal spatula,
mix the base material (yellow) and the
catalyst material(white) for 10-20
seconds until they are completely mixed
together and have turned into an ivory
color. | 1. Using a metal spatula 2, mix equal
volume units (1:1) of paste A (amber
color) and paste B (white color) of AH
Plus® root canal sealer on a glass slab
or the mixing pad supplied with the
package. Mix to a homogeneous
consistency. | |
| | 5. Measure the length of the root canal
by using an electronic apex locator or a
file. Select a gutta percha point
accordingly. Apply and coat a small
amount of the mixture to the gutta
percha point and insert the point towards
the apex slowly. alternatively, dentists
may choose to apply the mixture with a
paper point, a reamer, or Dia-Spiral Filler
(Lentulo spiral). In order to Prevent the
formation and entrapment of air bubbles
and overfilling the canal, the mixture-
coated points must be inserted very
slowly in a clockwise direction during
obturation and withdrawn in a counter
clock wise direction. If Lentulo spiral is
used, advance and withdraw the Lentulo
spiral slowly to the apex at very low
speed. | 2. Tightly close tubes after use.
3. Do not exchange caps of tubes. The
white cap belongs to paste A; the grey
сар
belongs to paste B.
Master-Point-Technique
- Select a gutta-percha point (or
alternatively a paper point or a reamer)
of the size of the last instrument used
during apical preparation. - Wet the canal walls with the material
through a pumping or simultaneously
rotating movement in a counter-
clockwise direction of the
point/reamer. Alternatively, apply the
material onto the tip of a Lentulo spiral. - Advance the Lentulo spiral slowly to
the apex running at very low speed.
Avoid the
formation of air bubbles in the material
and overfilling of the canal. - Withdraw Lentulo very slowly still
running at low speed. - Dip disinfected and dry master point
into the material and insert it into the
canal with
a slow pumping motion. | |
| | 6. Once the procedure is done, take an
X-Ray to check the seal. | | |
5
6
| Chemical
reaction
| mechanism | equivalent | ||
|---|---|---|---|
| Performance | |||
| Standard | |||
| Conformance | ISO6876 | ISO6876 | equivalent |
| Physical and | |||
| Mechanical | |||
| Properties | -. setting time | ||
| -. Film thickness | |||
| -. radiopacity | |||
| -. solubility | |||
| -. Flow | -. Working time | ||
| -. film thickness | |||
| -. radiopacity | |||
| -. Solubility | equivalent | ||
| Biocompatibility | Yes | Yes | equivalent |
| Use | Prescription/Hospital | Prescription/Hospital | equivalent |
| Delivery forms | |||
| (Design) | Manual mixing of Base and Catalyst | Manual mixing of paste A and Paste B | equivalent |
As demonstrated in the above comparison table, the subject and predicate devices have similar indication for uses, main ingredients, contents, biocompatibility, and conformance with standards. Also, the subject and predicate devices are using the same chemical reaction and classified as the same resin type (Epoxy resin based sealers) as a two part mixture design.
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5.6 Non-Clinical Performance Data
This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following standards:
| Standards | Contents | Relevant Tests
(Performed) |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| ISO 7405:2008 | Dentistry—Evaluation of biocompatibility of
medical devices used in dentistry | - |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk
management process | - |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part
3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity | •Bacterial Reverse
mutation |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part
5: Tests for in vitro cytotoxicity | •Cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part
10: Tests for irritation and skin sensitization | •Sensitization
•Irritation/Intracutaneous
reactivity |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part
11: Tests for systemic toxicity | •Acute systemic toxicity |
| ISO 6876:2012 | Dentistry — Root canal sealing materials | •Setting time
•Film Thickness
•Radio-opacity
•Solubility
•Flow |
5.7 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
5.8 Conclusions
Based on conclusions drawn from the testing results, the substantially equivalent to our legally marketed predicate device.