EQUA-PULL SAFETY RELEASE MODULE

K051751 · Ortho Technology · DZB · Jul 22, 2005 · Dental

Device Facts

• Record ID: K051751
• Device Name: EQUA-PULL SAFETY RELEASE MODULE
• Applicant: Ortho Technology
• Product Code: DZB · Dental
• Decision Date: Jul 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Device Story

Equa Pull Constant Force Headgear is an orthodontic accessory module. It connects to orthodontic face bows to provide consistent traction force during headgear treatment. The device functions as a mechanical safety release module; it delivers either light (12 oz) or heavy (24 oz) pull force. If excessive force is applied, the module triggers a release at 60-90 ounces to ensure patient safety. Used in clinical orthodontic settings under the direction of an orthodontist. The device benefits patients by providing controlled, predictable force application while mitigating risks associated with excessive tension during headgear wear.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical orthodontic headgear safety module. Provides constant force via internal spring or tension mechanism. Configured for 12 oz or 24 oz force levels with 60-90 oz safety release threshold. Non-electronic, non-software device.

Indications for Use

Indicated for orthodontic patients requiring headgear treatment; provides controlled pull force (12 or 24 oz) and safety release mechanism (60-90 oz) when connected to orthodontic face bows. Prescription use only.

Regulatory Classification

Identification

An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

JUL 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Klamic Director of Regulatory Affairs Ortho Technology 17401 Commerce Park Boulevard Tampa, Florida 33647

Re: K051751

Trade/Device Name: Equa Pull Constat Force Headgear Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral Orthodontic Headgear Regulatory Class: II Product Code: DZB Dated: June 27, 2005 Received: June 29, 2005

Dear Mr. Klamic:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to do rooms ic Act (Act) that do not require approval of a premarket the Federal F 600, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls 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 (1 WI (), it they of bacyed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of roundsh further announcements concerning your device in the Federal Register.

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## Page 2 -- Mr. Klamic

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 modifine and regulations and regulations administered by other Federal agencies. or the Act of ally I ouchas the Act's requirements, including, but not limited to: registration 1 od intilest compty was a 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as betronic 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) ring reter notification. The FDA finding of substantial equivalence of your device to a premainer results and mass of a sults 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), 11 you decire the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may count Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: Equa Pull Constant Force Headgear

## Indications for Use:

Equa Pull Constant Force Headgear is a safety release module used during the wear of Orthodontic Head Gear products, connected to Orthodontic Face Bows. The module is designed to provide pull force for treatment at light (12 ounce) or heavy (24 ounce) levels, and a release point force (60-90 ounces) for patient safety. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Over-The-Counter Use_ AND/OR Prescription Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Ms. Betz DNS for Dr. Susan Runner

of Anesthesiology, General Ho Infection Control, Denta

510(k) Number. K051751