3M AURORA SYSTEM

K972355 · 3M Company · EBZ · Aug 29, 1997 · Dental

Device Facts

• Record ID: K972355
• Device Name: 3M AURORA SYSTEM
• Applicant: 3M Company
• Product Code: EBZ · Dental
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

The 3M™ Aurora System is indicated to activate a photochemical polymerization reaction in light cure dental materials.

Device Story

3M Aurora System is a dental curing light. It functions by emitting light to trigger photochemical polymerization in light-cure dental materials. Used in dental clinics by dental professionals to harden restorative materials. The device provides a light source to facilitate the setting of dental composites, adhesives, or cements, thereby enabling dental restorations. No complex software or AI algorithms are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing device for dental materials. Operates via light emission to initiate polymerization. Class II device.

Indications for Use

Indicated for the activation of photochemical polymerization in light-cure dental materials. Intended for professional dental use.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa A. Weik Requlatory Affairs 3M Company Dental Products 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000

AUG 2 9 1997

Re : K972355 3M Aurora System Trade Name: Requlatory Class: II Product Code: EBZ Dated: June 25, 1997 Received: June 25, 1997

Dear Ms. Weik:

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 Requlation (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 requlation 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 - Ms. Weik

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 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 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.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 Radioloqical Health

Enclosure

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## 972355 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: 3M™ Aurora System _______________________________________________________________________________________________________________________________________________

Indications For Use:
The 3M™ Aurora System is indicated to activate a photochemical polymerization

reaction in light cure dental materials.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | KA7235 |
|---------------|--------|
|---------------|--------|

| Prescription Use<br>(Per 21CFR 801.109) | |
|-----------------------------------------|--|
|-----------------------------------------|--|

OR

| Over-the Counter Use | |
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