ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)

K982201 · Foremost Dental Mfg., Inc. · EBF · Aug 10, 1998 · Dental

Device Facts

• Record ID: K982201
• Device Name: ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
• Applicant: Foremost Dental Mfg., Inc.
• Product Code: EBF · Dental
• Decision Date: Aug 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.

Device Story

Zenith LuxaCore Automix is a dental core build-up material. It is used by dentists in a clinical setting to restore fractured, endodontically treated teeth. The material is applied around a cemented post to create a core foundation, allowing for the subsequent placement of a final dental restoration (e.g., crown). The device is supplied in an automix delivery system, facilitating consistent mixing and direct application to the tooth structure. It functions as a restorative material to rebuild tooth anatomy, enabling the patient to regain dental function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench-level assessment of the material's intended use and characteristics.

Technological Characteristics

Dental core build-up material; automix delivery system; chemical composition typical of dental restorative resins; intended for intraoral use.

Indications for Use

Indicated for use as a core material in endodontically treated teeth that are fractured, to build up the tooth structure around a cemented post to support a finished dental appliance.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1998

Mr. D. Tim Wolf ·Vice President Foremost Dental Manufacturing, Incorporated 242 South Dean Street Englewood, New Jersey 07631

Re : K982201 Zenith LuxaCore Automix Core Material Trade Name: (Multiple) Requlatory Class: I Product Code: EBF Dated: June 22, 1998 Received: June 22, 1998

Dear Mr. Wolf:

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 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 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 Reqister. 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. Wolf

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 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 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 the Office of Compliance at [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 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/dsma/dsmamain.html".

Sincerely yours,

S. Autman for

Timothy A. Ulatowski 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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FDA/ODE/DDIGD

S10(k) Number (if known): K982201

Device Name: Luxe core

Indications For Use:
- Core material-

when a tooth is fractured a Technique called
Post and core is used to restore functum.
A post is cemented into the endo dentically
Treated tooth. A core material is used to
build up around the tooth and post so
that a finished appliance can be placed.

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

Concurrence of CDRH, Office of Device Evaluation (ODB)

Susan Rumm

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

escription Use 2er 21 CFR 801.109)

O

O

OR

Over-The-Counter Use

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