SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70

K051010 · Septodont · EJJ · May 2, 2005 · Dental

Device Facts

• Record ID: K051010
• Device Name: SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
• Applicant: Septodont
• Product Code: EJJ · Dental
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up. The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up. The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

Device Story

Securalloy, Septalloy NG 50, and Septalloy NG 70 are dental amalgam alloys used by dentists for restorative procedures. These materials are placed into prepared cavities in posterior teeth to treat Class I and Class II lesions or to perform core build-ups. The devices function as traditional dental restorative materials, providing a durable filling for tooth structure loss. They are intended for professional use in a clinical dental setting. The healthcare provider uses these materials to restore tooth form and function, directly benefiting the patient by repairing decayed or damaged posterior teeth.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental amalgam alloys. These are metallic restorative materials used for posterior tooth fillings. The devices are provided as pre-dosed capsules or bulk alloy for mixing with mercury. No specific ASTM standards or advanced software/electronic components are described.

Indications for Use

Indicated for patients requiring dental restorations in posterior teeth, specifically for Class I and Class II cavities and core build-up procedures.

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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Image /page/0/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2005

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SEPTODONT C/O Mr. Wayne H. Matelski, Esq. Counsel for Septodont Arent Fox PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036

Re: K051010

Trade/Device Name: Securalloy, Septalloy NG 50, and Septalloy NG 70 Regulation Number: 21 CFR 872.3050 Regulation Name: Amalgam Alloy Regulatory Class: II Product Code: EJJ Dated: April 20, 2005 Received: April 21, 2005

Dear Mr. Matelski:

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 arior 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 nat ( 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 may of subject to can associations, 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 - Mr. Wayne H. Matelski, Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 112A s Issualice of a sassanial requirements of the Act or that FDA has made a decemination that your car Federal agencies. You must comply with any Federal Statutes and regulations administration of to: registration and listing (21 CFR Part 877); all the Act s requirements, morading, but novements as set forth in the quality labeling (21 CFR Part 801); good manalatestant of and if applicable, the electronic product radiation Systems (QD) 10Ballans (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 his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification: "The PDA mailie of backander of our 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 If you desire specific advice for your ac not 10-10-20115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misolanding of reference to promaibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number [phone] or Manufacturers, International and Corises http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quita H. Michaelons

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

Enclosures

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## INDICATIONS FOR USE - SECURALLOY

510(k) Number (if known): K05 | 0 | 0

SECURALLOY Dental Amalgam Device Name:

Indications for Use:

The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

Prescription Use メ (Part 21 CFR 801 Subpart D)

0%) Number:

1. 1. 1

AND/OR

Over-The-Counter Use (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)

Waln unne Moron Sign-Off)

Fision of Anesthesiology, General Hospital, I rection Control, Dental Devices

KOZIDID

.

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## INDICATIONS FOR USE - SEPTALLOY NG 70

510(k) Number (if known):

SEPTALLOY NG 70 Dental Amalgam Device Name:

Indications for Use:

The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

ﯿﮯ

× Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Syra Runnes

Ansion Sian-Off) ovision of Anesthesiology, General Hospital, Intection Control, Dental Devices

Page _1_of_1_

K Number: K051810

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## INDICATIONS FOR USE - SEPTALLOY NG 50

ROSION 510(k) Number (if known):

SEPTALLOY NG 50 Dental Amalgam Device Name:

Indications for Use:

The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

ﺒ

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 Runnus

Division Sign-Off)

ivision of Anesthesiology, General Hospital. Intection Control. Dental Devices 10(k) Number:

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