PARAGON

K991481 · Lancer Orthodontics, Inc. · EJJ · Aug 11, 1999 · Dental

Device Facts

• Record ID: K991481
• Device Name: PARAGON
• Applicant: Lancer Orthodontics, Inc.
• Product Code: EJJ · Dental
• Decision Date: Aug 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

paragon, a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.

Device Story

Paragon is a dental amalgam alloy; metallic substance mixed with mercury to create filling material for dental caries. Used by dental professionals in clinical settings to restore tooth structure damaged by decay. Device functions as a restorative material; provides mechanical support and sealing for cavities. Benefits include restoration of tooth function and prevention of further decay.

Clinical Evidence

bench testing only

Technological Characteristics

Metallic dental amalgam alloy; intended for mixing with mercury to form restorative filling material. Class II device (Product Code EJJ).

Indications for Use

Indicated for the treatment of dental caries in patients requiring dental amalgam restorations.

Regulatory Classification

Identification

Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 11 1999

Mr. Douglas D. Miller President and C.O.O. Lancer Orthodontics, Incorporated 253 Pawnee Street San Marcos, California 92069

Re : K991481 Paragon™ Trade Name: Requlatory Class: II Product Code: EJJ July 16, 1999 Dated: Received: July 20, 1999

Dear Mr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Miller

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Directbr

Sincerely yours

Timothy A. Ulatowski

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FROM LANCER CORPORATE 760 744 5842

Indications For Use:

12:39PM

paragon, a dental amalgam alloy, a device that consists of a metallic substance intended to be mixed with mercury to form a filling material for treatment of dental caries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

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(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Oplional Format 1-2-96)