(212 days)
No
The device description and performance studies focus on the physical and chemical properties of a root canal sealant, with no mention of AI or ML technologies.
No.
The device is a root canal sealer material, not used for therapy. It facilitates the permanent obturation (filling) of the root canal space, which is a post-treatment procedure.
No
Explanation: The device is described as a "root canal sealer" used for "permanent obturation of the root canal space." Its purpose is to seal or fill the root canal, which is a therapeutic rather than diagnostic function. There is no mention of it being used to detect, identify, or determine the presence or nature of a medical condition.
No
The device description clearly states it is a Zinc Oxide/Eugenol root canal sealant made up of a powder base and a liquid catalyst, indicating it is a physical material, 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 of the root canal space with the aid of obturating points." This describes a procedure performed directly on a patient's tooth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Zinc Oxide/Eugenol root canal sealant." This is a material used in a dental procedure, not a reagent or instrument used for in vitro testing.
- Anatomical Site: The anatomical site is the "root canal space," which is within the patient's body. IVDs typically interact with samples taken from the body (like blood, urine, tissue).
- Performance Studies: The performance studies focus on material properties like Consistency, Solubility, Work/Set Time, Film Thickness, and Biocompatibility. These are relevant to the physical and biological interaction of the material with the tooth and surrounding tissues, not the accuracy of a diagnostic test.
In vitro diagnostics are tests performed on samples outside of the body to provide information about a person's health. This device is a therapeutic material used directly within the body during a dental procedure.
N/A
Intended Use / Indications for Use
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed dental professionals
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: Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485:2012 Medical Devices- Quality Management Systems, and ISO 6876 Dental - Root Canal Sealing Materials, and the results demonstrated substantial equivalence to the predicate. Non-clinical performance data included testing for Consistency, Solubility, Work/Set Time, Film Thickness, and Biocompatibility testing. The data analyzed from the various tests substantiate that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate devices. The following standard was utilized for non-clinical performance testing of the proposed: ISO 6876:2012 Dentistry Root canal sealing materials.
Clinical Performance Data: Clinical performance testing has not been performed for Pulp Canal Sealer and Pulp Canal Sealer EWT.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Consistency: Proposed Pulp Canal Sealer: 28 mm, Proposed Pulp Canal Sealer EWT: 25 mm
Solubility: Proposed Pulp Canal Sealer: 0.34%, Proposed Pulp Canal Sealer EWT: 0.36%
Work/Set Time: Proposed Pulp Canal Sealer: Work Time: > 45 Minutes, Set Time: 6 Hours, Set Time:
§ 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2016
Sybron Dental Specialties Ms. Wendy Garman VP. Regulatory Affairs 1717 W. Collins Ave. Orange, California 92867
Re: K152956
Trade/Device Name: Pulp Canal Sealer and Pulp Canal Sealer EWT Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: March 7, 2016 Received: March 8, 2016
Dear Ms. Garman:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152956
Device Name
Pulp Canal Sealer and Pulp Canal Sealer EWT
Indications for Use (Describe)
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
| 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 comblete 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
Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. The logo is blue and white.
Pulp Canal Sealer and Pulp Canal Sealer EWT
- Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Heather Crilly |
|---|---|
| Telephone Number: | 909-962-5664 |
| Fax Number: | 909-962-5694 |
Date Prepared: May 05, 2016
-
- Device Name:
.
- Device Name:
.
●
- Proprietary Name: Pulp Canal Sealer and Pulp Canal Sealer EWT
- Classification Name: Root Canal Filling Resin 872.3820
- CFR Number: .
- Device Class: II
- Product Code: KIF .
-
- Predicate Device:
The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the legally marketed device Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) cleared on December 29, 1994, product code KIF.
-
- Description of Device:
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.
- Description of Device:
-
- Statement of Indications for Use:
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
- Statement of Indications for Use:
4
- Description of Substantial Equivalence 6.
Technological Characteristics:
The powder base formulation of the Proposed Pulp Canal Sealer and the predicate device, Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244), are very similar. The only difference being the formula range of the ingredient Thymol Iodide in the Pulp Canal Sealer product. The predicate Pulp Canal Sealer contains a higher limit of Thymol Iodide, while the Proposed Pulp Canal Sealer contains a lower formula range. The Proposed Pulp Canal Sealer EWT powder base remains unchanged.
The liquid catalyst is the same formulation used for both the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT and the predicate device, Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244). The liquid catalyst remains unchanged.
Pulp Canal Sealers are intended to fill the microscopic gaps between the root canal filler/obturator product (i.e. Gutta Percha) and the root canal wall. The powder base contains Zinc Oxide and the liquid catalyst contains Eugenol. The base and catalyst are combined and mixed into a homogenous paste which is then placed directly into the root canal as a thin layer. Once the Zinc Oxide and Eugenol are mixed, the Eugenol is consumed and converted into a solid complex. The sealer paste will set due to a chelation reaction between the Zinc Oxide and Eugenol. The hardening of the thin layer occurs within the root canal in the presence of moisture.
Thymol Iodide has no significance within the chemical reaction that takes place in the actual formation of the root canal sealant. The only known effect of the addition of Thymol Iodide is that it may accelerate set times. The difference between the predicate limit and the proposed limit of Thymol Iodide is a minor change, and no effect to the formulation could be measured or recorded.
The formulation utilizing the lowered formulation range of Thymol Iodide has been on the market for a number of years in Europe. Based on post market data and design verification testing, the performance characteristics of this material results are substantially equivalent to those of the predicate. The slight variation in Thymol Iodide does not change the performance characteristics of the device.
-
- Non-Clinical Performance Data:
Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485:2012 Medical Devices- Quality Management Systems, and ISO 6876 Dental - Root Canal Sealing Materials, and the results demonstrated substantial equivalence to the predicate. The Tables 5.1 and 5.2 below depict the modifications associated with Pulp Canal Sealer and Pulp Canal Sealer EWT.
- Non-Clinical Performance Data:
Non-clinical performance data included testing for Consistency, Solubility, Work/Set Time, Film Thickness, and Biocompatibility testing (refer to Table 6.2). The data analyzed from the various tests substantiate that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate devices. The following standard was utilized for non-clinical performance testing of the proposed:
5
- ISO 6876:2012 Dentistry Root canal sealing materials .
Clinical Performance Data:
Clinical performance testing has not been performed for Pulp Canal Sealer and Pulp Canal Sealer EWT.
| Element | Predicate Device-
Pulp Canal Sealer/Pulp Canal
Sealer EWT (K945244) | Proposed Pulp Canal Sealer
and Pulp Canal Sealer EWT
(K152956) |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Pulp Canal Sealer/Pulp Canal
Sealer EWT | Pulp Canal Sealer and Pulp
Canal Sealer EWT |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Device Description | Pulp Canal Sealer and Pulp
Canal Sealer EWT are used for
permanent obturation of the root
canal space with the aid of
obturating points in accordance
with ISO 6876 for Dental Root
Canal Sealing materials. | The Proposed Pulp Canal Sealer
and Pulp Canal Sealer EWT are
used for permanent obturation of
the root canal space with the aid
of obturating points in
accordance with ISO 6876 for
Dental Root Canal Sealing
materials. |
| Common Name | Root Canal Sealer | Root Canal Sealer |
| Classification Name | Root Canal Filling Resin
per 21 CFR § 872.3820 | Root Canal Filling Resin
per 21 CFR § 872.3820 |
| Class | II | II |
| Product Code | KIF | KIF |
| Powder Base Formula
for Pulp Canal Sealer
(PN 24875) Only | Contains:
Thymol Iodide | Contains:
Decreased range of Thymol
Iodide |
| Powder Base Formula
for Pulp Canal Sealer
EWT(PN 24746) Only | Formula per K945244 | No Change from K945244 |
| Catalyst Formula (Same
for both products) | Formula per K945244 | No Change from K945244 |
| Manufacturing Location | Romulus, MI (USA) | Scafati, Italy |
| Legal
Manufacturer/Spec
Developer | Kerr Corporation
Romulus, MI | SybronEndo
Glendora, CA |
| Packaging | Powder:
Cap - Polypropylene
Bottle – Polystyrene
Liquid:
Cap – Low Density Polyethylene
Bottle – Polypropylene | Powder:
Cap - Polypropylene
Bottle – Polystyrene
Liquid:
Cap –Low Density Polyethylene
Bottle – Polypropylene |
Table 5.1: Predicate Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) and Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT Device Comparison Table
6
Table 5.2: Predicate Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) and Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT Physical and Mechanical Properties Comparison
| PHYSICAL & MECHANICAL PROPERTIES COMPARISON | ||||
|---|---|---|---|---|
| Predicate Device (K945244) | Proposed Device (K152956) | |||
| Element | Pulp Canal | |||
| Sealer | Pulp Canal | |||
| Sealer EWT | Pulp Canal | |||
| Sealer | Pulp Canal | |||
| Sealer EWT | ||||
| Chemistry of | ||||
| Setting Reaction | Chelation between zinc oxide & eugenol | Chelation between zinc oxide & eugenol | ||
| Consistency | 29 mm | 28.5 mm | 28 mm | 25 mm |
| Solubility | 0.09% | 0.47% | 0.34% | 0.36% |
| Work/Set Time | Work Time: |
45 Minutes
Set Time:
6 Hours
Set Time:
45 Minutes
Set Time:
6 Hours
Set Time: