CONTINUM V

K040180 · Aalba Dent, Inc. · EJH · Mar 4, 2004 · Dental

Device Facts

• Record ID: K040180
• Device Name: CONTINUM V
• Applicant: Aalba Dent, Inc.
• Product Code: EJH · Dental
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3710
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is a non precious, nickel-chromium-molybdenum-berylium based dental casting alloy for use in the construction of cast ceramic bonded crown and bridge prostheses; according to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872, and bridge prostheses: "Reserving the group" a Class II device.

Device Story

Continum V is a non-precious, nickel-chromium-molybdenum-beryllium dental casting alloy; used by dental laboratory technicians to fabricate ceramic-bonded crown and bridge prostheses; material provides structural framework for dental restorations; final product is a custom-cast dental appliance placed by a dentist; benefits include durability and compatibility with ceramic veneering materials.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Base metal alloy; composition: nickel, chromium, molybdenum, beryllium; form factor: dental casting alloy; intended for crown and bridge prostheses; Class II device per 21 CFR 872.3710.

Indications for Use

Indicated for use in the construction of cast ceramic bonded crown and bridge prostheses in dental patients.

Regulatory Classification

Identification

A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Mr. Vincent M. Benetti Vice President, General Manager Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94534

Re: K040180

Trade/Device Name: Continum™ V Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: January 23, 2004 Received: January 27, 2004

Dear Mr. Benetti:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your Docton 910th production is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provide in May 26, 1770, the onleanent uith the provisions of the Federal Food, Drug, and Cosmetic nave bech techassified in woenanced of a premarket approval application (PMA). You may, Act (Act) that ao not require apple to the general controls provisions of the Act. The general therefore, mailed the detired, babyer se assimments for annual registration, listing of devices, good Controls provisions of cliebeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is classified (600 as 10) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish fourther announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Vincent M. Benetti

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 (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 mis letter writing on The FDA finding of substantial equivalence of your device to a legally premated noticated on 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 11 you don't be 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,

Chih S. Lin, PhD

Chiu S. Lin, PhD 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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11040180 510(k) Number (if known):

Continum V Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

This device is a non precious, nickel-chromium-molybdenum-berylium based This aevice is a non presious, mento on truction of cast ceramic bonded crown ceramic casing anoy for use in the coline to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872, and bridge prosinent acrices: "Reserving the group" a Class II device.

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

Susan Ruoper

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(per 21 CFR 801.109)

(optional format 1-2-96)