FUTURA GLASS IONOMER SILVER REINFORCED

K991974 · Ab Ardent · EMA · Sep 17, 1999 · Dental

Device Facts

• Record ID: K991974
• Device Name: FUTURA GLASS IONOMER SILVER REINFORCED
• Applicant: Ab Ardent
• Product Code: EMA · Dental
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries: 1. Class I and II cavities in deciduous teeth. 2. Repair of amalgam restored teeth (fractured restoration or tooth). 3. Class I and II cavities in selected permanent teeth. 4. Lining under amalgam or posterior composite restorations. 5. Cavities where radiopacity is a prime requirement. 6. Core build up material under crowns. 7. On root surface for locating overdentures. 8. Long term temporary replacement of cusps 9. Repairs to crown margins. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Prescription use

Device Story

Futura Glass Ionomer Silver Reinforced Restorative is a dental restorative material used by dental professionals (DDS/DMD) in clinical settings. It functions as a base, liner, and filling material for tooth structure lost to caries. The material provides radiopacity and is used for core build-ups, repairing amalgam restorations, and temporary cusp replacement. It is applied directly to the tooth structure by the clinician to restore function. The device benefits patients by providing a durable, radiopaque restorative option for various cavity classes and structural repairs.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Silver-reinforced glass ionomer restorative material. Designed for radiopacity. Formulated for use as a base, liner, and filling material in dental applications.

Indications for Use

Indicated for dental patients requiring restoration of tooth structure lost to caries, including Class I and II cavities in deciduous and selected permanent teeth, repair of fractured amalgam restorations or teeth, lining under amalgam or composite, core build-up, root surface overdenture location, cusp replacement, and crown margin repair.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

AB Ardent Clyde E. Ingersoll C/O: Ardent Product Development 54 Riverview Avenue Tonawanda, NY 14150

Re : K991974 Futura Glass Ionomer Silver Reinforced Trade Name: Restorative Requlatory Class: II Product Code: EMA Dated: Auqust 28, 1999 September 2, 1999 Received:

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 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 -Mr. Ingersoll

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborized 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 diaqnostic 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 the regaracion chercica) : IBBranding 77 Other general 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.fdac.gov/cdrh/dsmamain.html".

Sincerely Yours,

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

# AB ARDENT

Generatorgatan 8 S-195 60 Marsta Sweden +046 8 591 210 20 Phone [phone] FAX

510 (K)

## FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE

#### ATTACHMENT #4

## INDICATIONS FOR USE

510(k) Number: number not yet assigned

K991974

Device Name: FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE

FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:

- Class I and II cavities in deciduous teeth. 1.
- 2. Repair of amalgam restored teeth (fractured restoration or tooth).
- Class I and II cavities in selected permanent teeth. 3.
- 4. Lining under amalgam or posterior composite restorations.
- 5. Cavities where radiopacity is a prime requirement.
- 6. Core build up material under crowns.
- 7. On root surface for locating overdentures.
- 8. Long term temporary replacement of cusps
- ல் Repairs to crown margins.

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

Prescription use

(Division Sign-Off) famila Scott for Sucan Runner Division of Dental, Infection Control, and General Hospital Devices તુવાપા 510(k) Number -