IPS EMPRESS DIRECT FLOW

K103528 · Ivoclar Vivadent, Inc. · EBF · Feb 25, 2011 · Dental

Device Facts

• Record ID: K103528
• Device Name: IPS EMPRESS DIRECT FLOW
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPS Empress Direct Flow is a light-curing resin-based flowable dental restorative material indicated for , As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips) - As a thin (< 0.5mm) initial layer under Class I and II restorations - Small restorations of all types - Extended fissure sealing - | | | Splinting of mobile teeth - Blocking out of undercuts - Repair of composite and ceramic veneers

Device Story

IPS Empress Direct Flow is a light-curing, resin-based flowable dental restorative material. It is used by dental professionals in a clinical setting to restore tooth structure or repair existing restorations. The material is applied to the tooth surface or cavity preparation and cured using a dental light-curing unit. It functions as a restorative, filling, or sealing agent to improve esthetics and structural integrity of teeth. It benefits patients by providing a versatile, flowable medium for precise dental repairs and restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing resin-based flowable dental restorative material. Formulated for flowable application in dental restorations. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for dental patients requiring restorative procedures, including Class I and II restorations, composite/ceramic veneer repair, fissure sealing, splinting of mobile teeth, and blocking out of undercuts.

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)

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

Image /page/0/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's name encircling a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, representing health and human services.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Donna Marie Hartnett, Esq. Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

FEB 2 5 201

Re: K103528

Trade/Device Names: IPS Empress Direct Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Regulatory Class: II Product Codes: EBF, EBC, and EBD Dated: November 18, 2011 Received: November 30, 2011

Dear Ms. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Devices mark Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a provisions of
approval application (RMA) - You would (Act) that do not require approval of a approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements, The 21, and 600 to 698. In
Register Register.

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

## Page 2 - Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other requireme
You must comply with all the Act's requirement of other Federal agencies, You must comply with all the Act's requirements, including, but not limited to: registration
and listing (21 CFR Part 807), labeling (21 CFR Re, 1901), and listing (21 CFR Part 807); labeling (21 CFR Part 801); mot limited to: regist
(reporting of medical device-related education (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (21 CFR Part 820)
and if applicable, the electronic product radiation control provisions (Sections 531the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please go to please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet assist
http://www.afder.com/childers/100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Susan Rubin

Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

## 510(k) Number (if known: K103528

Device Name: IPS Empress Direct Flow Indications For Use:

IPS Empress Direct Flow is a light-curing resin-based flowable dental restorative material indicated for ,

As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations

Repair of composite restorations (in particular filling of voids, levelling out of -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------porosities and minor chips)

- As a thin (< 0.5mm) initial layer under Class I and II restorations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Small restorations of all types
- Extended fissure sealing
- | | | Splinting of mobile teeth
- Blocking out of undercuts
- Repair of composite and ceramic veneers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Prescription Use | X AND/OR |
|-----------------------------|----------|
| (Part 21 CFR 801 Subpart D) | |

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Susan Rubli(Division Sign-Off)

Division of Anesthesiology, General Hospital Concurrence of CDRH, Office of Deving Marken Bevices

510(k) Number: K103528