BONAMATES SERIES

K040650 · Biotech One, Inc. · JEY · Jun 3, 2004 · Dental

Device Facts

• Record ID: K040650
• Device Name: BONAMATES SERIES
• Applicant: Biotech One, Inc.
• Product Code: JEY · Dental
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

Device Story

BONAMATES® series are bone plates used in trauma and reconstructive surgical procedures of the midface and craniofacial skeleton. Intended for use by surgeons in clinical settings. Device provides structural support and fixation for bone segments during healing. No automated processing, software, or AI components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bone plate system; intended for midface and craniofacial fixation. Class II device (Product Code: JEY).

Indications for Use

Indicated for trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2004

BioTech One, Incorporated C/O Ms. Karen Uyesugi U.S. Consultant Uyesugi & Associates 92 Costa Brava Laguna Niguel, California 92677

Re: K040650

Trade/Device Name: BONAMATES® Series Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 29, 2004 Received: March 11, 2004

Dear Ms. Uyesugi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the relefenced above and nave acternialsoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to activelic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (boo acc iditional controls. Existing major regulations affecting (1 MA), it hay of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 -Ms. Uyesugi

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 1 D a determination that your device complies with other requirements modi that I Dri mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bane Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rate 007), abstitus (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadisation 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) This letter will anow your even finding of substantial equivalence of your device to a premarket notification. - Indevice 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), If you desire specific at 100 % pliance 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 obtain 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/dsma/dsmamain.html

Sincerely yours,

Carl Liu, 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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BioTech One, Inc. 510(k) Notification

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BONAMATES® Series

:

: : : : :

510(k) number (if known):

BONAMATES® Series Device Name:

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Indications for Use:

BONAMATES® Series:

The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.

Susan Ryan

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoulors.

510(k) Number:

(PLEASE DO NOT WRITE BFILOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ________

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