Who is the manufacturer of EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM?

Deltamed GmbH filed the 510(k) submission for EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM (K102776).

What is the FDA product code for EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM?

EBG. It is classified under 21 CFR 872.3770 as a Class 2 device in the Dental panel.

What is the regulatory pathway for EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM

K102776 · Deltamed GmbH · EBG · Feb 18, 2011 · Dental

Device Facts

Record ID	K102776
Device Name	EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
Applicant	Deltamed GmbH
Product Code	EBG · Dental
Decision Date	Feb 18, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3770
Device Class	Class 2

Intended Use

The c-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.

Device Story

e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based composite (difunctional acrylic monomers, silaceous fillers) used for temporary dental restorations. System includes resin and EXTRA-ORAL CURING SYSTEM. Unlike subtractive predicate (milling), this device uses additive manufacturing; CAM system cures resin in 0.1 mm layers to form crown/bridge shapes. Used in dental laboratories by technicians. Software guides formation and curing process. Output is a hard, esthetic temporary restoration mimicking natural tooth structure. Benefits include precise shape fabrication via additive CAM process.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Radiopaque, filled, resin-based composite; difunctional acrylic monomers and silaceous fillers. Additive manufacturing (CAM) system; 0.1 mm layer curing. Photocurable via high-intensity incandescent illumination. Standalone laboratory equipment.

Indications for Use

Indicated for fabrication of temporary dental restorations in dental laboratories using extra-oral curing light equipment.

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

VITA CAD TEMP (K070991)

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K192806 — DENTCA Crown and Bridge · Dentca, Inc. · Feb 5, 2020
K232050 — saremco print BRIDGETEC · Saremco Dental AG · Nov 14, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ K102776 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 {4}------------------------------------------------ ## 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<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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 | Page 1 of | 1 | |-----------|---| |-----------|---| | 510(k) Number: | K102776 | |----------------|---------| |----------------|---------| | Premarket Notification | DeltaMed GmbH<br>K102776: e-DENT TEMPORARY RESIN and EXTRA-ORAL AND CURING SYSTEM | Page 17 of 51 | |------------------------|-----------------------------------------------------------------------------------|---------------| |------------------------|-----------------------------------------------------------------------------------|---------------|