(147 days)
Not Found
No
The summary describes a dental resin and a CAM/curing system, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML details.
Yes
The device is a temporary dental restorative composite used to fabricate temporary dental restorations, which is a therapeutic purpose.
No
Explanation: The device is a resin used for fabricating temporary dental restorations, not for diagnosing any condition. Its function is to create a physical restoration, not to provide diagnostic information.
No
The device is a resin material intended for fabrication of temporary dental restorations, requiring extra-oral curing light equipment and a CAM and curing system. It is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication of temporary dental restorations." This is a direct treatment or restoration of a physical structure (teeth), not a diagnostic test performed on a sample from the body to gain information about a patient's health.
- Device Description: The description details a "resin-based temporary dental restorative composite" that is polymerized to form a "hard, esthetic, temporary restoration." This aligns with a material used for physical repair or replacement, not for in vitro analysis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to create a physical restoration that is placed in vivo (in the body).
N/A
Intended Use / Indications for Use
e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure.
e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Emanuel Mesaric, Managing Director DeltaMed GmbH Raiffeisenstr. 8a 61169 Friedberg Germany Tel. +49 (0) 6031 / 7283- 0 Fax. +49 (0) 6031 / 7283- 30 Website: www.deltamed.de E-mail: info@deltamed.de
CONTACT: Emanuel Mesaric
DATE PREPARED: February 2, 2011
TRADE OR PROPRIETARY NAME: e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM
CLASSIFICATION NAME: Temporary Crown and Bridge Resin, per 21 CFR 872.3770
PREDICATE DEVICE: K070991, VITA CAD TEMP, Temporary Crown and Bridge Resin, per 21 CFR 872.3770
This summary includes only information that is also covered in the body of this 510(k) document, does not contain any puffery or unsubstantiated labeling claims, does not contain any raw data, i.e., contains only summary data, and does not contain any patient identification information. Confidential formulas are included.
DEVICE DESCRIPTION: e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure.
e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.
INTENDED USE: The c-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
TECHNOLOGICAL CHARACTERISTICS vs. the predicate device: The c-DENT TEMPORARY RESIN is essentially identical to the predicate device. Both materials use Computer Aided Design files for their manufacture into temporary crowns or bridges in a laboratory. Clinical use of e-DENT TEMPORARY RESIN is substantially equivalent to VITA CAD TEMP.
DeltaMed GmbH Page 19 of 51 Premarket Notification K102776: e-DENT TEMPORARY RESIN and EXTRA-ORAL AND CURING SYSTEM
1
The VITA CAD TEMP material is a high molecular weight acrylate polymer with microfillers that were previously cured. The VITA CAD TEMP material is machined to its final shape using diamond instruments on a CAM device, which is known as subtractive manufacturing. By contrast, the e-DENT TEMPORARY RESIN uses additive manufacturing; that is a CAM system cures the resin in 0.1 mm layers to gradually form the precise shape for the crown or bridge.
OTHER: The e-DENT TEMPORARY RESIN was not evaluated for its specific biocompatibility because all components have been used in previously cleared resins manufactured by DeltaMed. The EXTRA-ORAL CURING SYSTEM was not evaluated for biocompatibility because no part of this equipment is used for patient contact.
We believe that the performance data provided herein support the safety and effectiveness of use of e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM.
2
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. Emanuel Mesaric Managing Director DeltaMed GmbH Raiffeisenstr. 8a D-61169 Friedberg GERMANY
FEB 1 8 201
Re: K102776
Trade/Device Names: e-Dent Temporary Resin and Extra-Oral Curing System Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: February 3, 2011 Received: February 16, 2011
Dear Mr. Mesaric:
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 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 concerning your device in the Federal Register. Son and i
3
Page 2 – Mr. Mesaric
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.html 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/Safetv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Antonin
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
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Indications for Use
510(k) Number (if known):K102776
Device Name: e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM
Indications For Use: e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | 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 De(Division Sign Off) (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
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| Premarket Notification | DeltaMed GmbH
K102776: e-DENT TEMPORARY RESIN and EXTRA-ORAL AND CURING SYSTEM | Page 17 of 51 |
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