GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

K973495 · Glenroe · ECI · Dec 1, 1997 · Dental

Device Facts

• Record ID: K973495
• Device Name: GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
• Applicant: Glenroe
• Product Code: ECI · Dental
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5410
• Device Class: Class 1

Intended Use

Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 4 to 6 weeks when they are replaced with new ties.

Device Story

Glenroe Glow In Dark Elastomeric Ligatures are orthodontic accessories used to secure archwires within brackets. Applied by orthodontists during routine treatment; ligatures hold archwire in place for 4-6 week intervals before replacement. Device provides aesthetic/functional benefit via glow-in-the-dark properties. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Elastomeric material; glow-in-the-dark additive; form factor is a small ligature tie for orthodontic brackets.

Indications for Use

Indicated for patients undergoing orthodontic treatment to secure archwires within orthodontic brackets.

Regulatory Classification

Identification

An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/0/Picture/3 description: The image shows the text "DEC - 1 1997". The text appears to be a date, with "DEC" representing the month of December, "1" representing the day, and "1997" representing the year. The text is written in a simple, sans-serif font and is easy to read. The text is black on a white background.

Mr. John Bozman ·Glenroe 1912 44th Avenue E. 34203 Bradenton, Florida

Re : K973495 Glenroe Glow In Dark Elastomeric Ligatures Trade Name: Regulatory Class: I Product Code: ECI September 15, 1997 Dated: September 16, 1997 Received:

Dear Mr. Bozman:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ 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 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

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Page 2 - Mr. Bozman

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 diaqnostic 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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Page

K973495 510(k) Number (if known):_

Glenroe Glow in Dark Elastomeric Ligatures Device Name:_

- Indications For Use: Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during They are normally used for a period orthodontic treatment. of 4 to 6 weeks when they are replaced with new ties.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quaer

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1995

Prescription Use
(Per 21 CFR 801.109i
OR

Over-The-Counter Use**_**
(Optional Format 1-2-96)