DENTCA Crown and Bridge

K192806 · Dentca, Inc. · EBG · Feb 5, 2020 · Dental

Device Facts

• Record ID: K192806
• Device Name: DENTCA Crown and Bridge
• Applicant: Dentca, Inc.
• Product Code: EBG · Dental
• Decision Date: Feb 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges. The fabrication of temporary crowns or bridges with DENTCA Crown and Bridge requires digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

Device Story

DENTCA Crown and Bridge is a light-curable resin material used for the additive manufacturing of temporary dental crowns and bridges. The process requires digital dental models, a stereolithographic (SLA) 3D printer, and post-processing curing light equipment. The resin is processed by the printer to create the physical temporary restoration, which is then cured to achieve final material properties. Used in dental clinics or laboratories by dental professionals to produce patient-specific temporary restorations as an alternative to preformed options. The final device serves as a temporary prosthetic to protect prepared teeth and maintain function/aesthetics during the period between tooth preparation and final restoration placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curable resin for additive manufacturing (stereolithography). Requires digital model input, SLA printer, and curing light. Material is a photopolymer resin.

Indications for Use

Indicated for the fabrication of temporary crowns or bridges via additive manufacturing for patients requiring temporary dental restorations.

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.

Submission Summary (Full Text)

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February 5, 2020

Dentca, Inc. % Joyce St. Germain Regulatory Executive The 510k Consulting, LLC 1449 Springleaf Dr Ormond Beach, Florida 32174

Re: K192806

Trade/Device Name: DENTCA Crown and Bridge Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: September 20, 2019 Received: October 1, 2019

Dear Joyce St. Germain:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K192806

Device Name Dentca Crown and Bridge

Indications for Use (Describe)

DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges.

The fabrication of temporary crowns or bridges with DENTCA Crown and Bridge requires digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

Type of Use (Select one or both, as applicable)

|× Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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