AMELOGEN PLUS

K043119 · Ultradent Products, Inc. · EBF · Dec 17, 2004 · Dental

Device Facts

• Record ID: K043119
• Device Name: AMELOGEN PLUS
• Applicant: Ultradent Products, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.

Device Story

Amelogen Plus is a Bis-GMA based resin composite material used by dentists for anterior and posterior tooth restorations. The device is applied to the tooth structure to restore form and function. It functions as a restorative dental material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bis-GMA based resin composite material for dental restoration. Class II device.

Indications for Use

Indicated for posterior and anterior tooth restoration in patients requiring dental composite resin treatment. Administered by dentists.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Ms. Tammy Lavery Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

Re: K043119

Trade/Device Name: Amelogen Plus Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 9, 2004 Received: December 13, 2004

Dear Ms. Lavery:

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 to 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 (1 11 ), it an 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 Eederal Register.

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## Page 2 - Ms. Lavery

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast be auvrood that I Dr a loomination that your device complies with other requirements mean that I Dr I has made statutes and regulations administered by other Federal agencies. of the Act of ally 1 ederal bulance and equirements, including, but not limited to: registration 1 ou interest comply was a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF rear on 1), a may on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of 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 mis rettor wification. The FDA finding of substantial equivalence of your device to a premaired notified.com - 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 you desire spleine arrow 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 ovean 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,

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

Ko43119 510(k) Number (if known): __Unknown

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.

Prescription Use Dentist Administered (Per 21 801 CFR Subpart D)

AND/OR

Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

ിvision Sıgn-Off) (Division Sign-Off)
Olvision of Anesthesiology, General Hospital,
Division of Anesthesioners, Ulvision of Anton Control. Devices

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Page 1 o (Posted November 13, 200)