FIRST FILL R.C.S.

K011748 · Jeneric/Pentron, Inc. · KIF · Aug 3, 2001 · Dental

Device Facts

• Record ID: K011748
• Device Name: FIRST FILL R.C.S.
• Applicant: Jeneric/Pentron, Inc.
• Product Code: KIF · Dental
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.

Device Story

FIRST FILL R.C.S. is a dental root canal sealant used for permanent obturation of root canals in conjunction with root canal points. The device consists of dental methacrylate resins. It is intended for professional use by dental clinicians in a clinical setting. The sealant is applied to the root canal to provide a permanent seal, aiding in the restoration and preservation of the tooth. The device functions as a chemical sealant material.

Clinical Evidence

No clinical data provided. Cytotoxicity results were submitted as part of the safety evaluation.

Technological Characteristics

Dental root canal sealant composed of methacrylate resins. Formulated for use with root canal points for permanent obturation. Class II device (Product Code: KIF).

Indications for Use

Indicated for permanent obturation of root canals of teeth in combination with root canal points.

Regulatory Classification

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.

Predicate Devices

• EndoRez Root Canal Sealant (K992097)

Submission Summary (Full 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: [phone] X619 Contact Fax: [phone] 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

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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 [phone]. Additionally, for questions on Compriance at (501) advertising of your device, please contact the Dromocron and adversions on [phone]. 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 [phone] 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.

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital | 510(k) Number .

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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.