TOTALBOND

K990381 · Parkell, Inc. · EMA · May 17, 1999 · Dental

Device Facts

• Record ID: K990381
• Device Name: TOTALBOND
• Applicant: Parkell, Inc.
• Product Code: EMA · Dental
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Indications for Use

Parkell's TOTALBOND is a dual-curing adhesive cement intended for use as a luting material for bonding inlays, onlays, crowns, and bridges to properly prepared teeth. It is also indicated for use as an agent for affecting repairs of tooth-colored veneers bonded to dental alloys, either non-precious or precious. For the latter instance, the supplied kit contains a noble metal-Priming material which significantly increases the bond strength of the repair. The kit also contains a porcelain-primer that is recommended for use in repairing fractured dental porcelains. It mediates an adhesive bond between the porcelain substrate and an overlying composite resin.

Device Story

TOTALBOND is a dual-curing adhesive resin cement system; used by dental professionals for luting dental restorations (inlays, onlays, crowns, bridges, veneers) to prepared teeth; also used for repairing fractured dental porcelains and veneers bonded to dental alloys. Kit includes noble metal primer to enhance bond strength to alloys and porcelain primer to facilitate bonding between porcelain substrates and composite resin. Device functions as a chemical adhesive interface; applied in clinical dental settings. Benefits include secure restoration retention and repair of dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-curing adhesive resin cement; includes noble metal primer and porcelain primer components. Chemical bonding mechanism.

Indications for Use

Indicated for luting inlays, onlays, crowns, bridges, and laminate veneers to prepared teeth; also indicated for repairing tooth-colored veneers bonded to precious or non-precious dental alloys and for repairing fractured dental porcelains by mediating an adhesive bond between porcelain and composite resin.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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## K99038

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## 510(k) SUMMARY

| Submitter: | Parkell Products Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: [phone]<br>FAX: [phone] |
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| Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735 |
| Submission Date: | February 3, 1999 |
| Trade Name: | TOTALBOND |
| Common Name: | Adhesive Resin Cement |
| Classification Name: | Cement, Dental (§872.3275) |
| Equivalence: | |
| Description/Intended Use: | Parkell's TOTALBOND is a dual-curing adhesive cement<br>intended for use as a luting material for bonding inlays, onlays,<br>crowns, and bridges to properly prepared teeth. It is also indicat-<br>ed for use as an agent for affecting repairs of tooth-colored<br>veneers bonded to dental alloys, either non-precious or precious.<br>For the latter instance, the supplied kit contains a noble metal-<br>Priming material which significantly increases the bond strength<br>of the repair. The kit also contains a porcelain-primer that is<br>recommended for use in repairing fractured dental porcelains. It<br>mediates an adhesive bond between the porcelain substrate and an<br>overlying composite resin. |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 1999

Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735

Re : K990381 Trade Name: TOTALBOND Regulatory Class: II Product Code: EMA Dated: April 30, 1999 Received: May 7, 1999

Dear Dr. Gendusa:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Dr. Gendusa

This letter will allow you to beqin 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 for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at [phone]. 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 [phone] or [phone] 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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K990381

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): )< 99038 |

Device Name: JoTAL BOND

Indications For Use:

A BURL. CURING ADHESIVE CEMENT INTENDED FOR USE AS A LUTING MATERIAL FOR BONDING INLAYS, ONLAYS, CROWNS, BRIDGES, LAMINATE VENEERS ETC. TO POSTERLY PERFARED TEETH. ALSO INDICATED AS AN AGENT FOR AFFECTING REPAIRS OF TOOTH . COLORED VENEED VENEERS BUNDED TO ATT ECTING READING FOR FREGOUS OR PRECIOUS . FOR THE LATTER, THE KIT CONTAINS A NOBLE METAL PRIMING MATERIAL WHICH SIGNIFICANTLY INCREASES THE BONS STRENGTH OF THE REPAIR. THE KIT ALSO CONTAINS A PORCELAIN PRIMER OF THE IS RECORITIENDED FOR WE IN REBAIRING FRACTURED DENTAL PORCECAINS. IT MEDIATES AN ADHESINE BOND BETWEEN THE PORCECAIN SUBSCRIPTE AND AN OVERLIANG COMPOSITE PESIN.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use Preserip CFR 801.109)

(Optional Format 3-10-98)

Susan Kummer
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices KAAO3S 510(k) Number -