DENTORIUM CONVERTIBLE ACRYLIC

K011820 · Nats Corp. · EBI · Sep 5, 2001 · Dental

Device Facts

• Record ID: K011820
• Device Name: DENTORIUM CONVERTIBLE ACRYLIC
• Applicant: Nats Corp.
• Product Code: EBI · Dental
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.

Device Story

Dentorium Convertible Acrylic is a heat-curing polymer material used by dental professionals in clinical or laboratory settings for the fabrication, repair, and modification of dental prostheses. The device functions as a restorative material for extending dentures, relining metal-based dentures, and supporting orthodontic treatments. It is applied by dental technicians or clinicians to restore or adjust prosthetic fit and function. The material is processed via heat curing to achieve its final structural form. By providing a durable, moldable acrylic base, the device enables the repair and customization of dental appliances, directly contributing to the restoration of patient oral function and prosthetic stability.

Clinical Evidence

bench testing only

Technological Characteristics

Heat-curing polymer material; dental prosthetic resin; form factor suitable for denture repair, relining, and orthodontic use.

Indications for Use

Indicated for dental patients requiring denture repair, denture extension, relining of metal dentures, or orthodontic applications. Contraindicated for individuals with sensitivity to the material; avoid inhalation or ingestion.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Dentorium Export, Limited C/O Mr. Richard C. Lanzillotto Aqent Nats Corporation 30 Northport Road 11789-1734 Sound Beach, New York

K011820 Re : Dentorium Convertible Acrylic Trade/Device Name: Regulation Number: 872.3760 Regulatory Class: II Product Code: EBI Dated: May 1, 2001 Received: June 11, 2001

Dear Mr. Lanzillotto:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beosed above and we have determined the market the device really equivalent (for the indications for device is Bubbeanerally one) to legally marketed predicate use stated in the chierstate commerce prior to May 28, 1976, devices marketed in I the Medical Device Amendments, or to che enactment acco oen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the roasian the device, subject to the general controls provisions of the Act. The general controls controls provisions of include requirements for annual provision, or the ing 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 be subject to back addroid device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancially oga Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Forch In Cho galation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug enrough porion (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Mr. Lanzillotto

In addition, FDA may publish further announcements action. action. In addition, For may pages al Register. Please note: concerning your device in arranket notification submission does Unis response to your premaint have under sections 531 not arrect any obligation for devices under the Electronic Chrough 342 or the not is not is on other Federal laws or regulations.

This letter will allow you to begin marketing your device as fills recei will arrow formarket notification. The FDA described in your 510 m, promilence of your device to a legally marketed predicate device results in a classification for your marketed predicate device ruse sub device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire operies and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compriance at (502) advertising of your device, please contact che promotion and adversions [phone]. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, obtained from the Divisumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatwoski 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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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

Dentorium Convertible Acrylic

R 611820

Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.

Contraindications:

May cause skin irritation. Avoid inhalation or ingestion.

(Please do not write Below This Line-Continue on Another Page if Needed)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Lildata

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 15 : O(k) Number _