DENTCA Crown and Bridge
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Dentca, Inc.
Identity
- Trade Name
- DENTCA Crown and Bridge EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- DENTCA Crown and Bridge - A1- 1kg FDA UDI
- Model / Reference
- DENTCA Crown and Bridge A1 EUDAMED04301 EUDAMEDDENTCA Crown and Bridge FDA UDI
- Description
- DENTCA Crown and Bridge - A1- 1kg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856551007407 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856551007407 EUDAMED
- 510(k) Number
- K192806 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)FDA UDI
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Weight — 1 Kilogram FDA UDI
The DENTCA Crown and Bridge Resin is a photocurable polymer material designed for additive manufacturing of dental crowns and bridges. It is classified as a dental resin for temporary or provisional restorations, intended to replicate the structural properties of conventional acrylic while enabling digital fabrication.
This resin is supplied as a liquid for use in 3D printing systems, specifically compatible with Carbon printers, to create temporary dental restorations. Fabricated crowns and bridges are intended for short-term use (up to 30 days) and are not intended for permanent placement. The device holds FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD)
Frequently asked questions
What types of dental restorations can this resin be used to create, and how long are they intended to last?
The DENTCA Crown and Bridge Resin is designed specifically for additive manufacturing of temporary or provisional dental crowns and bridges. It replicates the structural properties of conventional acrylic resins but is fabricated digitally using compatible Carbon 3D printers. These restorations are intended for short-term use only, up to 30 days, and are not meant for permanent placement in the patient’s mouth.
Is this resin compatible with any specific 3D printing systems, and how is it supplied?
Yes, the DENTCA Crown and Bridge Resin is exclusively compatible with Carbon printers for additive manufacturing. It is supplied as a liquid material in a format designed for use within these systems, enabling precise digital fabrication of temporary restorations.
What regulatory pathways has this device undergone, and how does that affect its use?
The DENTCA Crown and Bridge Resin holds FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD). These clearances confirm its safety and effectiveness for the intended use as a temporary dental restoration material, but it remains restricted to short-term applications as specified.
Are the fabricated crowns and bridges single-use or reusable, and how should they be handled?
The DENTCA Crown and Bridge Resin is intended for single-use only after fabrication, as the resulting restorations are designed for temporary placement (up to 30 days). Since they are not meant for reuse, proper sterilization or reprocessing is not applicable. Instead, clinicians should follow standard dental protocols for handling temporary restorations, including appropriate disposal after use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DENTCA Crown & Bridge, DENTCA 3D Printing Crowns & Bridge Resin - Carbon, PDF DENTCA Crown and Bridge - Directions for Use
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192806 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentca, Inc.
Sources (3)
- FDA 510(k) K192806 24 fields · synced Sep 18, 2026
- FDA UDI 4f4405c6-0e43-45af-953d-fd04d5c4fd04 36 fields · synced May 30, 2026
- EUDAMED 54194a1f-d2b2-4f7a-925e-6338c216e79b 61 fields · synced Aug 3, 2026