(58 days)
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points. The resins used in First Fill RCS are the common dental methacrylate resins.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental root canal sealant (FIRST FILL R.C.S.) seeking substantial equivalence to a predicate device.
Specifically, the document states:
- No acceptance criteria: The document does not define any specific performance metrics or thresholds that the device needed to meet.
- No performance study: There is no description of a study conducted to assess the performance of FIRST FILL R.C.S. against any criteria. The basis for clearance is substantial equivalence.
- Substantial Equivalence: The primary information provided is that Jeneric/Pentron, Inc. believes FIRST FILL R.C.S. is "substantially equivalent to Ultradent's EndoRez Root Canal Sealant, K992097" and that the FDA concurred with this determination based on the premarket notification. The materials are noted as "common dental methacrylate resins" and "Cytotoxicity results have been submitted in Section 15.0" (though Section 15.0 is not provided).
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.
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AUG = 3 2001
KO11748
21.0 510(K) SUMMARY
Jeneric/Pentron, Inc. Submitter: 53 North Plains Industrial Road Address: Wallingford, Connecticut 06492 Contact Tel: 203-265-7397 X619 Contact Fax: 203-265-7662 Contact Person: Annmarie Tenero
Date Summary Prepared: June 5, 2001
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in I ITED I ILD with root canal points. Despite minor differences in the materials, we believe FIRST FILL R.C.S. is substantially equivalent to Ultradent's EndoRez Root Canal Sealant, K992097. The resins used in First Fill RCS are the common dental methacrylate resins. The 1372071. The resimblation used ones for various dental applications. Cytotoxicity results have been submitted in Section 15.0.
Jeneric/Pentron, Inc. 510K Submission - FIRST FILL R.C.S.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2001
Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724
K011748 Re : First Fill R.C.S Trade/Device Name: Regulation Number: 872.3820 Requlatory Class: II Product Code: KIF Dated: June 5, 2001 Received: June 6, 2001
Dear Ms. Tenero:
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Tenero
concerning your device in the Federal Register. Please note: concerning your acour premarket notification submission does chis response to your for you might have under sections 531 through 542 of the Act for devices under the Electronic Chrough 542 or the nec re- consisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Info recei wire 510 (k) premarket notification. The FDA described in your sie (i) privalence of your device to a legally rinding of bubbandasice results in a classification for your marketed predicate acvice your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpcorrie additionally 809.10 for in regulacion (i' devices) , please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) advertising of your device, please contact the Dromocron and adversions on (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other general information on your responsibilities under the Act may be Information on your in Journal Manufacturers Assistance obcathed from the Divisesson) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Victorl
Ulatowski Timothy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): K011748
DEVICE NAME: FIRST FILL R.C.S.
INDICATION FOR USE: FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.
SwarupRuma
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital | 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over -The-Counter-Use 5.0 (Optional Format 1-2-96)
Jeneric/Pentron, Inc. 510K Submission - FIRST FILL R.C.S.
§ 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.