(272 days)
No
The device is a photosensitive resin used in a CAD/CAM process. While the process involves digital files and optical impressions, there is no mention or indication of AI/ML being used in the resin itself or the described fabrication steps.
No.
This device is a light-cured resin used for the fabrication and repair of dental prosthetics (dentures and baseplates), which are medical devices but not therapeutic in nature themselves. It replaces missing teeth, thereby restoring function, but does not treat a disease or perform therapy.
No
This device is a resin used for the fabrication and repair of dental prosthetics (dentures and baseplates), not for diagnosing medical conditions.
No
The device is a photosensitive resin, which is a physical material used in a manufacturing process, not a software-only device.
Based on the provided information, the Dentca Denture Base is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication and repair of full and partial removable dentures and baseplates." This is a device used to create a physical prosthetic for the patient's mouth.
- Device Description: The description details a photosensitive resin used in a CAD/CAM additive printing process to build a physical denture base.
- Function: The device's function is to be the material from which a dental prosthetic is made. It does not perform any diagnostic testing on a sample taken from the human body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Dentca Denture Base does not fit this description. It is a material used in the manufacturing of a medical device (a denture).
N/A
Intended Use / Indications for Use
Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.
Product codes
EBI
Device Description
Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.
The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12.
The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist office, dental lab
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)
Biocompatibility evaluation was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. Testing included Genotoxicity, Cytotoxicity, Sensitization, Irritation, Acute Toxicity, and Material Characterization.
Electrical Safety and EMC: The low voltage 3D printer was certified to conform to EN 60950 and EMC standards EN 55022, EN 55024, EN 61000-3-2, EN 61000-3-3, and EN 60825-1.
Software Verification and Validation Testing: The optical scanning impression system was validated in conformance with ISO 12836.
Bench Testing: Dentca Denture Base was tested for conformity with ISO 20795-1.
Key performance specifications include:
Flexural strength: 90.2 MPa
Flexural modulus: 2,290 MPa
Residual monomer: Not detectable
Water sorption: 14 ug/mm3
Water solubility: 1.3 ug/mm3
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Dentca. Inc. c/o Mr. Claude Berthoin Denterprise International, Inc. 110 East Granada Blvd. Suite 207 Ormond Beach, Florida 32176
Re: K143033
Trade/Device Name: Dentca Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 15, 2015 Received: June 18, 2015
Dear Mr. Berthoin.
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.
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143033
Device Name
Dentca Denture Base
Indications for Use (Describe)
Dentca Denture Base is a light-cured resin indication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.
Fabrication of dental prosthetics with Denture Base requires a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 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 801 Subpart C) |
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3
K143033 510(k) Summary
Submitter
Dentca, Inc. 3608 Griffith Avenue Los Angeles, CA 90011
Phone: 323-232-7505 Fax: 323-232-7504
Contact Person: Jason Lee Date Prepared: July 20, 2015
Consultant
Denterprise International, Inc. 110 East Granada Blvd., Suite 207 Ormond Beach, FL 32176
Phone: 386-672-0450 eFax: 855-235-7902
Contact Person: Claude Berthoin, President
Device Classification
Trade Name: Dentca Denture Base Common Name: Dental Acrylic Resin Regulation Number: 21 CFR 872.3760 Denture relining, repairing, or rebasing resin Regulation Name: Product Code: EBI Submission Type: 510(k) Regulatory Class: 2 Medical Specialty: Dental
Primary Predicate Device
The following primary predicate is a legally marketed, post-amendment device:
| 510(k) Number: | K032892 |
|---|---|
| Clearance Date: | September 26, 2003 |
| 510(k) Trade Name: | Trubyte Denture Base Resin System |
| Actual trade names: | Trubyte Triad VLC (Visible Light Cure) Denture Base System; |
| Trubyte Eclipse VLC Denture Base System | |
| Manufacturer: | Dentsply International, Inc. (York, PA, USA) |
| Regulation & PC: | 872.3760; EBI |
4
Reference Device
The following reference predicate is a legally marketed, post-amendment device:
| 510(k) Number: | K102776 |
|---|---|
| Clearance Date: | February 18, 2011 |
| 510(k) Trade Name: | e-Dent Temporary Resin and Extraoral Curing System |
| Actual Trade Name: | EnvisionTEC E-Dent 100 |
| Manufacturer: | DentaMed GmbH (Friedberg, Germany) |
| Regulation & PC: | 872.3770; EBG |
Device Description
Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.
The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12.
The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
Key performance specifications include:
| Flexural strength... | 90.2 MPa |
|---|---|
| Flexural modulus... | 2,290 MPa |
| Residual monomer... | Not detectable |
| Water sorption... | 14 ug/mm3 |
| Water solubility... | 1.3 ug/mm3 |
Indications For Use
Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heatcured and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.
Both the subject and predicate are light-cure resins indicated for fabrication and repair of removable dental prostheses.
5
Comparison Of Technological Characteristics With Predicate
The following table compares technological and other characteristics of the subject and primary predicate devices.
| | K143033
Subject Device | K032892
Predicate Device | Differences |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Names | Dentca Denture Base | Dentsply Trubyte
Denture Base Resin
System | NA |
| Classification &
Product Code | 872.3760; EBI | 872.3760; EBI | SAME CLASSIFICATION |
| Intended Use | Fabrication and repair of
removable dentures,
appliances and prostheses | Fabrication and repair of
removable dentures,
appliances and prostheses | SAME INTENDED USE |
| Indication For Use | Dentca Denture Base is a light-
cure resin indicated for
fabrication and repair of full and
partial removable dentures and
baseplates. The material is an
alternative to traditional heat-cured
and auto-polymerizing resins... The device requires a
CAD/CAM system that includes
the following components not
part of the device: oral casting
impression, digital denture base
file created in an optical
impression system, stereo
lithographic additive printer, and
curing light equipment. | Trubyte Denture Base Resin
System is [a light-cure resin]
indicated for fabrication and
repair of dentures,
appliances and prostheses,
and for relining of denture
surfaces. | BOTH DEVICES ARE
LIGHT-CURE RESINS
INDICATED FOR
FABRICATION AND
REPAIR OF REMOVABLE
DENTAL PROSTHESES. |
| Device Description | | | |
| Acrylic Resin | Light-cure resin | Light-cure resin | SAME TECHNOLOGY |
| Chemical
Characterization | Methacrylate-based resins
with photoinitiator, inhibitor
and pigments | Methacrylate-based resins
with photoinitiator, inhibitor
and pigments | SAME TECHNOLOGY |
| Polymerization
(Curing) Method | Visible light | Visible light | SAME TECHNOLOGY |
| Product State | Pre-mixed resin | Pre-mixed resin | SAME TECHNOLOGY |
| Fabrication of
Denture Base | Automated 3D printing of resin
in multiple layers, each light-cured
before adding next
layer, with post curing in light
chamber | Manual application of resin
in multiple layers, each light-cured
before adding next
layer, with post curing in
light chamber | Manual vs. automated
application technology |
| Post Curing | Visible light-curing unit | Visible light-curing unit | SAME TECHNOLOGY |
| Teeth Assemble | Bonding | Bonding | SAME TECHNOLOGY |
Table 5 -- Comparison Of Technical Features
6
The above comparison shows the only technological difference between the denture polymers is method of resin application to fabricate the denture base, with the subject applied in an automated optical method and the predicate in a manual mechanical process.
A comparison of the subject and reference showed that both devices fabricate the denture base in the same manner, via automated application of a light-cure resin in an additive CAD/CAM printer.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for Dentca Denture Base was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1, as recognized by FDA. The battery of testing included the following tests:
- Genotoxicity .
- Cytotoxicity ●
- Sensitization ●
- . Irritation
- Acute Toxicity
- . Material Characterization
The denture base is considered tissue contacting for a period longer than 30 days (a removable prosthesis).
Electrical Safety and EMC
The low voltage 3D printer used to fabricate the denture base from the Denture Base light-cure resin was certified by the printer manufacturer to conform to EN 60950 (Safety of Information Technology Equipment) and the following EMC standards: EN 55022. EN 55024, EN 61000-3-2, EN 61000-3-3, and EN 60825-1.
Software Verification and Validation Testing
The optical scanning impression system used to convert cast impressions into 3D digital images was validated by the scanner manufacturer in conformance with ISO 12836.
Bench Testing
Dentca Denture Base was tested for conformity with the industry consensus standard ISO 20795-1.
7
Conclusions
The subject and predicate devices have the same intended use and substantially similar technological characteristics, with the exception of the method of fabricating the denture base. Because the subject introduces a new additive printing technology as part of a CAD/CAM manufacturing process, an acceptable reference device was brought in to demonstrate prior use of this new technology.
The non-clinical data support the substantial equivalence of the subject device and demonstrate that Dentca Denture Base should perform as intended in the specified use conditions.