NITOM LOCKING FACEBOW

K052553 · Russell Samuels Orthodontic Design · DZB · Dec 22, 2005 · Dental

Device Facts

• Record ID: K052553
• Device Name: NITOM LOCKING FACEBOW
• Applicant: Russell Samuels Orthodontic Design
• Product Code: DZB · Dental
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.

Device Story

The Nitom Locking facebow is an extraoral orthodontic appliance constructed of stainless steel. It consists of an inner bow featuring two mechanical catches or locks designed to prevent accidental dislodgement during sleep. The device is attached to extraoral traction tubes on the patient's fixed orthodontic appliance (upper first molars) and connected to a headcap or neckstrap. Operated by the patient at home during evenings and nighttime, the device utilizes the back of the head or neck as an anchor to apply a backward force to the upper molar teeth. This force prevents forward migration of the molars, thereby improving anchorage and assisting in achieving successful orthodontic treatment outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Stainless steel. Form factor: Orthodontic facebow with inner bow and two mechanical locking catches. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for orthodontic patients, typically children aged 9 to 16 years, requiring backward force on upper molar teeth to prevent forward movement during orthodontic treatment. Used with headcap or neckstrap.

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.

Predicate Devices

• Nitom Locking facebow (K980245)

Submission Summary (Full Text)

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

K 052553

0

### DEC 2 2 2005

# 5. 510K Summary (As required by section 807.92(c))

5.1.

ं द

Owners name and contact person (807.92 (a)(1)): Dr. Russell Henry Ashleigh Samuels.

| Owners address: | 7 Cricket Lane,<br>Loughborough,<br>Leicestershire,<br>LE11 3PD,<br>England, UK. |
|-------------------|----------------------------------------------------------------------------------|
| Telephone number: | 01509 (0044 1509) 216480. |
| Summary prepared: | 9th September 2005. |

#### 5.2.

Device classification name (807.92 (a)(2)): Headgear, Extraoral, Orthodontic.

Trade name of device: Nitom Locking facebow.

The common name: Orthodontic facebow.

- 5.3.
An identification of the legally marketed device to which the submitter claims equivalence is (807.92 (a) (3) ):

| Classification Advisory committee: | Dental |
|------------------------------------|-----------------------|
| Product code: | DZB. |
| Regulation number: | 872.5500 |
| Device name: | Nitom Locking facebow |
| 510K number: | K980245. |

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

#### ર્સ વ

#### Description of The Device (807.92 (a)(4)):

The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars. It is usually worn by the patient in the evening and at night. It improves the anchorage of the upper back teeth. It is made of stainless steel.

#### ર . રાં

Statement of intended use of the device (807.92 (a)(5)).

The nitom locking facebow is used by the Dental speciality of Orthodontics in the treatment of some orthodontic patients. The patients are usually children aged 9 to 16 years of age. The device is usually worn in the evenings and at night time while asleep. It is attached to a headcap or neckstrap at one end and to the upper molar teeth at the other end. It uses the back of the head or neck to apply a backward force to the upper molar teeth to prevent them moving forward during orthodontic treatment. It is a very useful device in helping to achieve a successful outcome in some cases.

7

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing wings or feathers.

Public Health Service

DEC 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Russell Henry Ashleigh Samuels Russell Samuels Orthodontic Design 7 Cricket Lane Loughborough, Leicestershire LE11 3PD England UNITED KINGDOM

Re: K052553

Trade/Device Name: Nitom Locking Facebow Regulation Number: 872.5500 Regulation Name: Extraoral Orthodontic Head Gear Regulatory Class: II Product Code: DZB Dated: November 22, 2005 Received: December 2, 2005

Dear Dr. Samuels:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becalen by (2) + = device is substantially equivalent (for the referenced above and have decembica the device is enatketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predice Medical Dev indications for use stated in the cholors, to regionent date of the Medical Device interstate comments prior to way 20, 1770, as can reclassified in accordance with the provisions of Amendments, or to devices that nave obcil recisement of a premarked on the premarked the Federal Food, Drug, and Cosmetic Free/ market the device, subject to the general
approval application (PMA). You may, therefore, market the Associal of approval appreation (1 Mr.). " Tou 1107) rail controls provisions of the Act include controls provisions of the Act. The general occurrent of devices, good manufacturing practice, lequirements for anitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III if your device is classified (sec above) into ennorols. Existing major regulations affecting (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Andrea in the F your device can be found in the Code of Pederal Neg.
addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

### Page 2 - Dr. Samuels

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 moun that I Driving and regulations administered by other Federal agencies. 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 and insting (21 CF reviews 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) I mo reter mtification. The FDA finding of substantial equivalence of your device to a promaince hotel 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), r Jou don't 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 maj count 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/industry/support/index.html.

Sincerely yours,

Syitte y. Michael Oms

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

{4}------------------------------------------------

K052553

## Indications for Use

510(k) Number (if known): K052553

Nitom Locking Facebow Device Name:

The Nitom Locking facebow is a type of Indications For Use: orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

K052553

Page 1 of