ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)

K103474 · Micerium S.P.A. · EBG · Feb 7, 2011 · Dental

Device Facts

• Record ID: K103474
• Device Name: ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
• Applicant: Micerium S.P.A.
• Product Code: EBG · Dental
• Decision Date: Feb 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).

Device Story

ENA TEMP/ENAMEL PLUS TEMP is a powder and liquid resin system for creating aesthetic temporary crowns and bridges. Used by dental professionals in clinical or laboratory settings. Direct method involves silicone impressions or preformed crowns; indirect method utilizes diagnostic waxing or vacuum-formed matrices. The system provides temporary restorative solutions for patients requiring crown or bridge work. No complex electronics or software involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and adherence to ISO 20795 and ISO 10477 standards for dental materials.

Technological Characteristics

Powder and liquid resin system. Complies with ISO 20795 (denture materials) and ISO 10477 (crown and bridge materials).

Indications for Use

Indicated for aesthetic temporary crown and bridge fabrication in dental patients. Used by dental professionals via direct (in-mouth) or indirect (laboratory) methods.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH (K000894)

Submission Summary (Full Text)

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K103474

# FEB - 7 2011

## CONFIDENTIAL

## 510(k) Summary

Submitter: Mr. Eugenio Miceli, QA Manager, Micerium SpA, Via Marconi, 83, 16036 Avegno (GE), Italy. Phone: [phone].

- Classification Name and Number: Crown And Bridge, Temporary, Resin (EBG 872.3770). I.
- II. Common/Usual Name: Powder and liquid resin for temporary crowns and bridges.
- III. Proprietary Name: ENA TEMP and ENAMEL PLUS TEMP (two different proprietary names for the same product).
- IV. Registration No .: Foreign, in process
- V. Compliance with Performance Standards: "ISO 20795" for denture materials and "ISO 10477" for crowns and bridges.
- Description of the Device: ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and VI. powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). Please note that the resin is absolutely the same, but they will be sold with two different brand names for commercial reasons. So, in order to simplify, from here on they will be denoted as "Temp"
- VII. Labels and Labeling: Draft labels and instructions for use are provided.
- Substantial Equivalence: K000894 C&B RESIN PLUS POWDER/LIQUID, MODELS VIII. RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH. RE by DENTAL VENTURES OF AMERICA, INC

VIII.1. Risk for health

- 1. Allergic reaction
- 2. No or incomplete stability
- 3. Gaps at tooth side if not tight
- Secondary caries 4.
- 5. Irritation of respiratory system and skin (only for liquid)
- Indications for Use: ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder IX. resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). X.
- Premarket notification truthful and accurate statement.

(End of Summary)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

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

Dr. Carla Tazzer Quality Control MICERIUM S.D.A. Via Marconi, 83 16030 Avegno ITALY

FEB - 7 201

Re: K103474

Trade/Device Names: ENA Temp and Enamel Plus Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: November 15, 2011 Received: November 26, 2011

Dear Dr. Tazzer:

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 Device 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 premarket 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 warrantics. 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 concerning your device in the Federal Register.

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Page 2 - Dr. Tazzer

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 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 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.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

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CONFIDENTIAL

#### 103471 IX. Indications for Use [Separate Page]

510(k) Number (if known): (not assigned)

Device Name: ENA TEMP, ENAMEL PLUS TEMP

### Indications For Use:

ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Dunne

(Division Sign-Jff) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesistori Control, Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________