(122 days)
Not Found
No
The 510(k) summary describes a root canal sealer and its physical and biocompatibility testing, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
Yes
The device is a root canal sealer used for the permanent sealing of root canals, which is a therapeutic intervention.
No
Explanation: SimpliSeal is described as a root canal sealer for permanent sealing, which is a therapeutic rather than a diagnostic function. The device description and intended use focus on treatment, not on identifying a disease or condition.
No
The device description clearly states it is a root canal sealer delivered in a dual-barrel syringe, which is a physical product, not software.
Based on the provided information, SimpliSeal is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "permanent sealing of root canals." This is a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: SimpliSeal is a "root canal sealer," a material used to fill and seal the root canal space. This is a physical material used in a treatment procedure.
- Lack of Diagnostic Purpose: There is no mention of SimpliSeal being used to detect, measure, or analyze any substance or characteristic in a sample from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are typically used to perform tests on samples like blood, urine, tissue, etc., to provide information about a patient's health status. SimpliSeal is a material used in a dental treatment procedure.
N/A
Intended Use / Indications for Use
SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
SimpliSeal is intended for use by qualified healthcare personnel trained in its use.
Product codes
KIF
Device Description
SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.
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
qualified healthcare personnel
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 physical tests have been completed on SimpliSeal:
Setting time - per ISO 6876
Flow - per ISO 6876
Film thickness – per ISO 6876
Solubility -- per ISO 6876
Dimensional change following setting - per ISO 6876
The following biocompatibility tests have been completed on SimpliSeal:
Cytotoxicity - ISO 10993-5
Acute Systemic Toxicity (oral) - ISO 10993-11
Irritation - ISO 10993-10
Sensitivity - ISO 10993-10
Genotoxicity - ISO 10993-3
All testing is within specification and the device performs as designed. The results demonstrate that the device is safe, effective and performs as well as or better than products that are already legally marketed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
K 69.3208
FEB 1 2 2010
, 1
510(k) Summary - SimpliSeal
- Contact Person: 1.
B.
Clark D. vonAhsen Associate, Regulatory Affairs Discus Dental, LLC 8550 Higuera Street Culver City, CA 90232 310.845.8216 - phone 310.845.8647 - fax clarkv(@discusdental.com
May 28, 2009 Date of Summary Preparation:
-
- Name of Medical Device
| Proprietary Name: | SimpliSeal |
|---|---|
| Common/Usual Name: | Root Canal Sealer |
| Classification Name: | Resin, Root Canal Filling (KIF) |
- Substantial Equivalence Determination: 3.
Discus Dental, LLC believes that SimpliSeal is substantially equivalent to the following commercially marketed products:
| Predicate Device | Company | 510(k) No. |
|---|---|---|
| Adseal | Meta BioMed Co., LTD | K042769 |
| AH-Plus | Dentsply Intl. | K960548 |
Description of Medical Device: 4.
SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.
1
-
- Intended Use:
SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
- Intended Use:
SimpliSeal is intended for use by qualified healthcare personnel trained in its use.
- Discus Dental, LLC believes that SimpliSeal is substantially equivalent to the 6. following commercially marketed products:
| | Discus Dental
--- | Meta BioMed Co.,
LTD
--- | Dentsply Intl.
--- |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SimpliSeal | Adseal | AH-Plus |
| Labeling | Permanent root canal
sealer | Permanent root
canal sealer | Permanent root
canal sealer |
| Intended Use | SimpliSeal is a root
canal sealer for the
permanent sealing of
root canals following
established
endodontic
procedures and may
be used in
conjunction with the
auxiliary materials in
the root canal (i.e.
gutta percha points).
Intended for use by
qualified healthcare
personnel trained in
its use. | For permanent
sealing of root
canals following
established
endodontic
procedures and
may be used in
conjunction with
the auxiliary
materials in the
root canal (i.e.
gutta-percha
points).
Intended for use by
qualified
healthcare
personnel trained
in its use. | AH PLUS Root
Canal Sealer is
used for permanent
sealing of root
canals following
established
endodontic
procedures.
Intended for use by
qualified
healthcare
personnel trained
in its use. |
| Similar Physical
Properties | ISO 6876 fluidity,
working time, film
thickness,
radiopacity, solubility
& disintegration | ISO 6876 fluidity,
working time, film
thickness,
radiopacity,
solubility &
disintegration | ISO 6876 fluidity,
working time, film
thickness.
radiopacity,
solubility &
disintegration |
| Design,
Construction,
Components | Premixed, two part
paste, packaged in
tow component
plastic syringe ready
to be dispensed and
mixed. | Premixed, two part
paste, packaged in
tow component
plastic syringe
ready to be
dispensed and
mixed. | Premixed, two part
paste, packaged in
tow component
plastic syringe
ready to be
dispensed and
mixed. |
2
The following physical tests have been completed on SimpliSeal:
Setting time - per ISO 6876 Flow - per ISO 6876 Film thickness – per ISO 6876 Solubility -- per ISO 6876 Dimensional change following setting - per ISO 6876
. The following biocompatibility tests have been completed on SimpliSeal:
Cytotoxicity - ISO 10993-5 Acute Systemic Toxicity (oral) - ISO 10993-11 Irritation - ISO 10993-10 . Sensitivity - ISO 10993-10 Genotoxicity - ISO 10993-3
All testing is within specification and the device performs as designed. The results demonstrate that the device is safe, effective and performs as well as or better than products that are already legally marketed.
END OF 510(k) SUMMARY
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or flowing ribbons.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 2 2010
Mr. Clark D. Von Ashsen Associate, Regulatory Affairs Discus Dental, L.L.C. 8550 Higuera Street Culver City, California 90232
Re: K093208
Trade/Device Name: SimpliSeal Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 21, 2010 Received: January 22, 2010
Dear Mr. Von Ashen:
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.
4
Page 2 -- Mr. Von Ashen
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,
hm far
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
E. Indications for Use Statement
510(k) Number (if known): _K0643208
Device Name: SimpliSeal
Indications for Use:
SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
SimpliSeal is intended for use by qualified healthcare personnel trained in its use.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR :
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
\underline{RSBetz Das for Dr. K. P. Mully}
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093208
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