MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL

K030776 · Discus Dental, Inc. · ELW · May 9, 2003 · Dental

Device Facts

• Record ID: K030776
• Device Name: MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
• Applicant: Discus Dental, Inc.
• Product Code: ELW · Dental
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

Mega Bite is designed for making accurate occlusal records.

Device Story

Mega Bite is an impression material used by dental professionals to capture accurate occlusal records. The material is applied intraorally to record the relationship between the maxillary and mandibular teeth. It functions as a dental impression material to facilitate restorative or diagnostic procedures. The output is a physical dental record used by clinicians to guide clinical decision-making in dental treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impression material for dental occlusal registration. Class II device under 21 CFR 872.3660. Physical properties consistent with standard dental impression materials.

Indications for Use

Indicated for use in dental patients requiring the creation of accurate occlusal records.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Yogi Shah Regulatory Affairs Specialist Discus Dental, Incorporated 8550 Higuera Street Culver City, California 90232

Re: K030776

Trade/Device Name: Mega Bite Registration Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 10, 2003 Received: March 11, 2003

Dear Ms. Shah:

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 Amendments, or tc devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code 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. Yogi Shah

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 of the Act or any Federal statutes 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 requirements as set forth in the quality systems (OS) 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) 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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,

Surer Runser

Susan Runner, DDS, MA Interim 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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1030776 510(K) Number :

Device Name : Mega Bite Registration

Indication For Use:

Mega Bite is designed for making accurate occlusal records.

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Prescription Use

OR

Over-The -- Counter-Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Ke-Mulley for MSRZ

510(k) Notification .cus Dental Inc

of Anesthesiology, General Hospital. ction Control, Den

510(k) Number: