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). 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"

AI/ML Overview

This document describes a 510(k) premarket notification for a dental device, specifically a temporary crown and bridge resin. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials with specific acceptance criteria and outcome measurements usually found in PMAs or clinical studies for novel devices.

Therefore, the requested information about acceptance criteria, study design, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies is largely not present in the provided text. The submission focuses on compliance with performance standards and comparison to a predicate device.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Compliance with ISO 20795 (Denture Materials)	Listed as complying.
Compliance with ISO 10477 (Crowns and Bridges)	Listed as complying.
Substantial Equivalence to K000894 (C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH. RE by DENTAL VENTURES OF AMERICA, INC)	Stated as substantially equivalent. The specific performance metrics used for this equivalence are not detailed.
Addressing identified risks:	The document lists risks (Allergic reaction, No or incomplete stability, Gaps at tooth side if not tight, Secondary caries, Irritation of respiratory system and skin) but does not provide specific performance data or tests demonstrating how these risks are mitigated or how performance meets criteria related to them.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not mentioned. No specific "test set" in the context of a clinical performance study is described. The evaluation appears to be based on bench testing (compliance with ISO standards) and comparison to existing products.
Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The submission is from Micerium SpA, Italy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not mentioned.
Qualifications: Not mentioned.

This type of information would be relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or AI-driven device. This submission is for a material used in dentistry, and its performance evaluation likely relies on material science testing rather than expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

MRMC Study: No, an MRMC study was not done. This device is a dental material, not an AI-driven diagnostic tool or a system involving human readers interpreting outputs.
Effect Size of AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance would primarily be established through material property testing against ISO standards (ISO 20795 for denture materials and ISO 10477 for crowns and bridges) and comparison to the identified predicate device (K000894) based on specifications and intended use. There is no mention of pathology, outcomes data from patients, or expert consensus in the clinical sense for establishing ground truth for this particular submission.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The device is a resin for temporary crowns and bridges.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

Summary

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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: +39 0185 7885 880.

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
1. No or incomplete stability
1. Gaps at tooth side if not tight
Secondary caries 4.
1. 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 (800) 638-2041 or (301) 796-7100 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:

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: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
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.(b)
Classification. Class II.