ASTRALIS 10, MODELS # 559588, 561859

K013275 · Ivoclar Vivadent, Inc. · EBZ · Oct 19, 2001 · Dental

Device Facts

• Record ID: K013275
• Device Name: ASTRALIS 10, MODELS # 559588, 561859
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBZ · Dental
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Astralis 10 is a hand held polymerization unit used to cure dental composites

Device Story

Astralis 10 is a handheld dental polymerization unit. Device emits light to cure light-activated dental composite materials. Operated by dental professionals in clinical settings. Provides controlled light output to initiate polymerization process, hardening restorative materials. Benefits include efficient, reliable curing of dental composites during restorative procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Handheld polymerization unit; light-based curing; electrical power source; Class II device (21 CFR 872.6070).

Indications for Use

Indicated for use by dental professionals to cure dental composite materials.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Submission Summary (Full Text)

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OCT 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K013275

Trade/Device Name: Astralis 10, Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 21, 2001 Received: October 1, 2001

Dear Ms. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Hartnett

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/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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| 510(k) Number (if known): | Pending K013275 |
|---------------------------|-----------------|
| Device Name: | Astralis 10 |

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Indications For Use:

Astralis 10 is a hand held polymerization unit used to cure dental composites

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Robert Shatz DDS for Dr. Susan Kummer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -4