(70 days)
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder and liquid) root canal sealer that is capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder/liquid) root canal sealer capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.
The provided text is a 510(k) summary for a root canal sealer, not a study evaluating acceptance criteria for a device's performance. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device's intended use and classification but offers no performance data or study results.
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K060946 p.1gl/
510(k) SUMMARY
| Submitter: | Parkell, Inc.155 Schmitt Blvd.Box 376JUN 16 2006Farmingdale, NY 11735TEL: 631-249-1134FAX: 631-249-1242 |
|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 |
| Submission Date: | 31 March 2006 |
| Trade Name: | Currently Not Available |
| Common Name: | Root Canal Sealer |
| Classification Name: | Root Canal Sealing Resin |
| Equivalence: | ADSEAL, ENDOREZ, FIRST FILL and SEALAPEX |
| Description/Intended Use: | A biocompatible, radiopaque, resin-based, self-etching,dual-cure, two-part (powder/liquid) root canal sealercapable of bonding with gutta percha or resinous pointsas well as the surrounding walls of a properly reamedand filed root canal to affect a durable seal of that canal. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 2006
Nelson J. Gendusa, D.D.S. Director of Research PARKELL, Incorporated 300 Executive Drive Edgewood, New York 11717
Re: K060946 Trade/Device Name: CZ-S2000 Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Medium large Regulatory Class: II Product Code: KIF Dated: March 31, 2006 Received: April 6, 2006
Dear Dr. Gendusa:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Dr. Gendusa
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ciris
Shia-Jing, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K060946 510(k) Number (if known):
Device Name: Not yet available.
Indications for Use:
A biocompatible, radiopaque, resin-based, self-etching, dual-cure, two-part (powder and liquid) root canal sealer that is capable of bonding with gutta percha or resinous points as well as the surrounding walls of a properly reamed and filed root canal to affect a durable seal of that canal.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runiz
: ( :r) of Anasthesiology, General Hospital Control, Dental Devic
Page 1 of 1
Kolacny
§ 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.