FUTURA TOPCAP NON GAMMA-2

K011801 · Ab Ardent · EJJ · Aug 16, 2001 · Dental

Device Facts

• Record ID: K011801
• Device Name: FUTURA TOPCAP NON GAMMA-2
• Applicant: Ab Ardent
• Product Code: EJJ · Dental
• Decision Date: Aug 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3070
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.

Device Story

FUTURA TOPCAP non gamma-2 is a dental restorative filling material. It is applied by dentists (DDS/DMD) in a clinical setting following the removal of carious tooth tissue. The material is used to restore function to teeth affected by caries, specifically for direct, fixed restorations including single and multi-surface cavities, pinned onlays, half crowns, and core build-ups for cast crowns. It functions as a structural filling agent to replace lost tooth structure.

Technological Characteristics

Dental restorative filling material. Non-gamma-2 composition. Intended for direct, fixed dental restorations.

Indications for Use

Indicated for dental patients requiring restoration of teeth with carious lesions, including Class I, MO, DO, FO, LO, MOD, and FOD cavities, pinned onlays, half crowns, and core build-ups for cast crowns. For use by dental professionals (DDS/DMD) only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 6 2001

AB Ardent C/O Mr. Clyde E. Ingersoll Regulatory/Quality Assurance Manager Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260

Re: K011801 Futura Topcap Non Gamma-2 Trade/Device Name: 872.3050 Regulation Number: II Requlatory Class: Product Code: EJJ June 5, 2001 Dated: Received: June 8, 2001

Dear Mr. Ingersoll:

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 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). provisions or or ore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ಡ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 – Mr. Ingersoll

concerning your device in the Federal Register. Please note: concerning your device in the reactification submission does this response to your premarker sections 531 not arrect any obligation you megs under the Electronic through 542 of the Act 101 devices and of other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis lecter will ario(k) premarket notification.
described in your 510(k) premarket not your device The FDA described in your 510(K) prematic normalence of your device to a legally
finding of substantial equivalence of classification for your marketed predicate device results in a classification for your marketed predicate device rebares in a can a can a charge to the market.

If you desire specific advice for your device on our labeling If you desire specific advise additionally 809.10 for in regulation (21 crk raros), please contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), proad otionally, for questions on Compliance at (301) 554 inin. of your device, please contact the promocion and adversibility on July 2017 - 11so, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarked nocification (area. Justics under the Act may be Information on your respon of Small Manufacturers obtained Trom the Division on its toll-free number International and Comballers internet at its internet address [phone] - 2011 - 2007 - 32 - 4 - 4 - 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - 1 - - 1 - - 1 - - - - - - - - - - - -

Sincerely yours,

Oin S-E/on
Timothy A. Ulatowski

Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT #4 FUTURA TOPCAP non gamma-2 510 (k)

## INDICATIONS FOR USE

510(k) Number: number not yet assigned

Device Name: FUTURA TOPCAP non gamma-2

FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Labels will bear this caution.

Llewellyn Sharper for MSR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KO11801 510(k) Number _