POWER COINS GLOW IN THE DARK LIGATURES

K980864 · Ortho Kinetics Corp. · ECI · Apr 20, 1998 · Dental

Device Facts

• Record ID: K980864
• Device Name: POWER COINS GLOW IN THE DARK LIGATURES
• Applicant: Ortho Kinetics Corp.
• Product Code: ECI · Dental
• Decision Date: Apr 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5410
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.

Device Story

Power Coins Glow in the Dark ligatures are orthodontic accessories used by dentists to secure archwires within orthodontic brackets during the treatment of malocclusions. The device functions as a mechanical ligature, providing a glow-in-the-dark feature for aesthetic or identification purposes. Ligatures are applied by the clinician during office visits and are intended for short-term use, typically replaced every 2 to 4 weeks. The device assists in maintaining the position of the archwire to facilitate tooth movement as part of a prescribed orthodontic treatment plan.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Orthodontic ligature; glow-in-the-dark material; mechanical retention device; Class I, Product Code ECI.

Indications for Use

Indicated for patients requiring orthodontic treatment for malocclusions. Used by dentists to secure archwires in 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)

{0}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 20 1998

Mr. Steven O. Luse ·President Ortho Kinetics Corporation 1611A South Melrose Drive, Suite 16 Vista, California 92083-5407

Re : K980864 Power Coins Glow in the Dark Ligatures Trade Name: Requlatory Class: I Product Code: ECI Dated: March 2, 1998 Received: March 5, 1998

Dear Mr. Luse: _

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 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 (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. ਰੈ substantially equivalent-determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Luse

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.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 Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known): K980864

Device Name: "Power Coins Glow in the Dark ligatures

Indications For Use:

This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="signature" src="signature.png"/> </div> |
|---------------------------------------------------------------------|---------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980864 |

| Prescription Use <span style="text-decoration: underline;">☑</span> (Per 21 CFR 801.109) | OR | Over-The-Counter Use <span style="text-decoration: underline;">_____</span> |
|------------------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------|

(Optional Format 1-2-96)