TETRIC FLOW

K993783 · Ivoclar North America, Inc. · EBF · Dec 13, 1999 · Dental

Device Facts

• Record ID: K993783
• Device Name: TETRIC FLOW
• Applicant: Ivoclar North America, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Class V restorations (cervical caries, root erosion, wedge shaped defects) Anterior restorations (Class III and IV) Small posterior restorations Restorative therapy for mini-cavities, of all types (preparation with Sonic-Sys Micro Instruments from KaVo) Adhesive cementation of Sonic-Sys Inlays Extended fissures sealings in molars and pre-molars Repair of composite/ceramic veneers Blocking out of undercuts Adhesive cementation of ceramic and composite restorations

Device Story

Tetric Flow is a light-activated hybrid composite dental material. Used by dentists in clinical settings for restorative procedures including cavity filling, fissure sealing, and adhesive cementation of restorations. Applied directly to prepared tooth surfaces or restorations; cured via light activation to achieve hardening. Benefits include versatility in restorative therapy, repair of existing veneers, and structural support for undercuts. Operates as a restorative dental material; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-activated hybrid composite dental material. Formulated for flowable application in dental restorations. No electronic components, software, or connectivity features.

Indications for Use

Indicated for dental patients requiring Class V, III, or IV restorations, small posterior restorations, mini-cavity restorative therapy, fissure sealing, veneer repair, undercut blocking, and adhesive cementation of inlays, ceramic, or composite restorations.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 1999

Mr. Peter P. Mancuso Requlatory/Quality Assurance Manager Ivoclar North America, Inc. 175 Pineview Drive Amherst, NY 14228

Re : K993783 Light activated hybrid composite Trade Name: Requlatory Class: II Product Code: EBF November 3, 1999 Dated: Received: November 8, 1999

Dear Mr. Mancuso:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations 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 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 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

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Page 2 - Mr. Mancuso

obligation you might have under sections 531 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 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 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

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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CONFIDENTIAL

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Page

510(k) Number (if known): |(993783

Tetric Flow Device Name:

## Indications For Use:

- Class V restorations (cervical caries, root erosion, wedge shaped defects) 1
- -Anterior restorations (Class III and IV)
- Small posterior restorations -
- Restorative therapy for mini-cavities, of all types (preparation with -Sonic-Sys Micro Instruments from KaVo-)
- Adhesive cementation of Sonic-Sys Inlays
- -Extended fissures sealings in molars and pre-molars
- -Repair of composite/ceramic veneers
- । Blocking out of undercuts
- -Adhesive cementation of ceramic and composite restorations

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Runner

(Division Sign-Off) Division of Dental, Infection O and General Hospital De 510(k) Number