(51 days)
No
The summary describes a root canal filling material and its performance based on ISO standards, with no mention of AI or ML.
Yes
The device is a root canal sealer, which is used in conjunction with gutta percha or silver endodontic points to fill root canals, thereby treating dental conditions.
No
This device is a root canal sealer, filling the root canal in conjunction with gutta percha or silver endodontic points. Its purpose is to seal, not to diagnose a condition.
No
The device description clearly states it is a "two-paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material," which is a physical substance, 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 to be a root canal sealer used in conjunction with gutta percha or silver endodontic points. This is a material used within the body (specifically, the root canal) to fill and seal it.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: The description confirms it's a root canal filling material, not a device for analyzing biological samples.
- Anatomical Site: The anatomical site is the root canal, which is an internal part of the body.
Therefore, the Kerr Modified Sealapex Root Canal Sealer is a medical device, but it falls under the category of a dental device used for treatment within the body, not an IVD.
N/A
Intended Use / Indications for Use
Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
Modified Sealapex is a root canal sealing material. The modified formulation involves two changes: 1) Substitution of poly(methylene methyl salicylate) resin with NPG-TMP Salicylate resin. 2) The addition of bismuth trioxide to increase the radiopacity of the set sealant. It is a two-paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal / periapical area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental profession
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)
Safety: The safety of the modified Sealapex formulation has been demonstrated in extensive animal histopathology studies.
Efficacy: The effectiveness of the modified Sealapex formulation has been demonstrated by comparison testing of several predicate devices to the requirements of ISO International Standard 6876 for Dental root canal sealing materials.
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
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Page 1 of 2
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510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr Modified Sealapex Root Canal Sealer
BACKGROUND
Sealapex is a root canal sealing material which has been used successfully by the dental profession since 1984. The original Sealapex formulation received market clearance from the Food and Drug Administration in July of 1984 ( 510 ( k ) Reference Number K841910 ).Another 510 ( k ) application was submitted in September, 1994 for minor formulation changes to extend the working time ( 510 ( k ) Reference Number K944480 ). This submission addresses two anticipated formulation modifications which will, when implemented, make the manufacturing process for synthesizing one of the polymeric resins safer to the employees, and increase the radiopacity by fifty per cent.
Current Sealapex formulations utilize Poly(methylene methyl salicylate) resin in the catalyst paste component. It is synthesized in-house using formaldehyde as one of the reactants. Formaldehyde is considered to be carcinogenic and presents a serious hazard in the workplace. If Neopentyl glycol disalicylate/ trimethylol propane trisalicylate ( NPG-TMP salicylate ) resin is substituted for the current resin, the use of formaldehyde is eliminated. The second modification consists of the addition of bismuth trioxide to the catalyst component to increase the radiopacity of the mixed sealant.
Modified Sealapex
The two formulation changes described above do not alter the safety and efficacy of the product to the extent that the new formulation is not significantly equivalent to products currently on the market and under the jurisdiction of FDA. This is demonstrated below:
Change Number 1: Substitution of poly(methylene methyl salicylate) resin with NPG-TMP Salicylate resin. NPG-TMP Salicylate has been used successfully and safely since 1996 in Kerr's Life Cavity Base/Liner ( 510 ( k ) Reference Number K961708 ). And, in fact, that resin change was made for exactly the same reasons described in this submission and was based on extensive animal histopathology studies which demonstrated both the biocompatibility of the resin and the ability of the calcium hydroxide ingredient to stimulate the formation of hard tissue both in the periapical area and along the canal walls as well.
Change Number 2: The addition of bismuth trioxide to increase the radiopacity of the set sealant. Bismuth trioxide has been used previously in root canal sealers. Procosol. Grossman's Sealer, Wach's Paste, Diaket and AH-26 all use bismuth compounds as radiopaquing agents. In the case of AH-26, it has 60 % by weight bismuth trioxide All of these products are currently on the market under the jurisdiction of FDA.
A table of comparative ingredient lists for the modified Sealapex formulation along with predicate device compositions, where known is included elsewhere in this submission in order to contrast and compare the various devices.
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Page 2 of 2
Safety
The safety of the modified Sealapex formulation has been demonstrated in extensive animal histopathology studies. Copies of reports of these studies are included elsewhere in this submission.
Efficacy
The effectiveness of the modified Sealapex formulation has been demonstrated by comparison testing of several predicate devices to the requirements of ISO International Standard 6876 for Dental root canal sealing materials. A copy of this standard as well as a table of comparative results can be found elsewhere in this submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Mr. William R. Pike Regulatory Affairs Specialist Sybron Dental Specialities, Incorporated 2717 W. Collins Avenue -Orange, California 92667
Re: K972369 Trade Name: Sealapex Regulatory Class: II Product Code: KIF June 6, 1997 Dated: Received: June 25, 1997
Dear Mr. Pike:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಥ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Pike
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification focument device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 ( k ) Number :
Device Name : Kerr Modified Sealapex Root Canal Sealer
Indications For Use : Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.
Susan Runsey
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ Jeg 72369
Prescription Use
(Per 21 CFR 801.109)