VITALESCENCE

K974282 · Ultradent Products, Inc. · EBF · Jan 29, 1998 · Dental

Device Facts

• Record ID: K974282
• Device Name: VITALESCENCE
• Applicant: Ultradent Products, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vitalescence is used for direct and indirect esthetic restorations in anterior and posterior sections.

Device Story

Vitalescence is a dental restorative material used by dentists for esthetic restorations in anterior and posterior teeth. It is applied directly or used in indirect restorative procedures to restore tooth structure, improve appearance, and provide functional support. The material is placed by a clinician to fill cavities or reconstruct tooth anatomy, hardening to provide a durable, esthetic finish. It benefits patients by restoring dental function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Dental restorative material for anterior and posterior use. Physical and chemical properties consistent with standard dental composite restorative materials.

Indications for Use

Indicated for direct and indirect esthetic restorations in anterior and posterior tooth sections.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1998

Mr. Chester McCoy Regulatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South South Jordan, Utah 84065

K974282 Re: Vitalescence Trade Name : Regulatory Class: II Product Code: 대한민국 공급 및 Dated: November 11, 1997 Received: November 14, 1997

Dear Mr. McCoy:

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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. McCoy

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.

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 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.fida.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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K974282 510(k) Number (if known):

Device Name: _Vitalescence

Indications For Use:

网址

Vitalescence is used for direct and indirect esthetic restorations in anterior and posterior sections.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Rurr

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

Prescription Use _(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)