PERMAFLO

K974413 · Ultradent Products, Inc. · EBF · Feb 2, 1998 · Dental

Device Facts

• Record ID: K974413
• Device Name: PERMAFLO
• Applicant: Ultradent Products, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PermaFlo can be used for: 1. Anterior and posterior restorations, such as Class I, II, III, IV, and V. 2. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable. 3. Direct veneers and other restorative procedures: 4. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).

Device Story

PermaFlo is a flowable composite resin used by dental professionals for restorative dentistry. It serves as a restorative material for various cavity classes, luting agent for translucent inlays/onlays, and material for direct veneers and subgingival structure buildup. Applied by clinicians in a dental office setting, the material is placed into the tooth preparation and light-cured to harden. The device benefits patients by providing a versatile, flowable restorative option that adapts to tooth structure, facilitating both aesthetic and functional dental repairs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flowable composite resin material. Designed for light-curing. Used for dental restorative and luting applications.

Indications for Use

Indicated for patients requiring anterior/posterior dental restorations (Class I-V), luting of translucent inlays/onlays, direct veneers, and subgingival tooth structure restoration prior to endodontic procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Chester McCoy
Regulatory Affairs Manager
Ultradent Products, Incorporated
505 W. 10200 South
South Jordan, Utah 84095
FEB - 2 1998

Re: K974413
Trade Name: Permaflo
Regulatory Class: II
Product Code: EBF
Dated: November 20, 1997
Received: November 24, 1997

Dear Mr. McCoy:

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 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulation may result in regulatory 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 obligation you might have under sections 531

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Page 2 - Mr. McCoy

through 542 of 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 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 regulation (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 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
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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Page 1 of 1

510(k) Number (if known): Unknown K974413

Device Name: PermaFlo Flowable Composite

Indications For Use:

PermaFlo can be used for:

1. Anterior and posterior restorations, such as Class I, II, III, IV, and V.
2. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
3. Direct veneers and other restorative procedures:
4. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K974413

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☑ (Optional Format 1-2-96)