DentoCore / DentoCore Body
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DENTOCORE FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- DENTOCORE EUDAMED
- Model / Reference
- DCSAK1 EUDAMEDAutomix FDA UDI
Identifiers
- Catalog Number
- DCSAK1 FDA UDI
- Primary DI / UDI-DI
- 03760260222006 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760260222006 EUDAMED
- 510(k) Number
- K121769 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)FDA UDI
- Market of Registration
- France 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
Yes
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
The DentoCore / DentoCore Body is a dual-cure composite resin indicated for dental core build-ups. It is designed to provide high mechanical strength, minimal shrinkage, and precise application in restorative procedures, with added fluoride release for enhanced caries protection.
This device is supplied as a professional-use dental material, available in cartridges with mixing and intraoral tips. It is classified as a Class IIa medical device under the MDD and holds FDA 510(k) clearance (K121769) as substantially equivalent. Storage and handling must comply with manufacturer instructions to maintain sterility and performance, though specific sterility claims are not provided.
Frequently asked questions
What types of dental procedures is the DentoCore / DentoCore Body specifically designed for, and why is it preferred in those cases?
The DentoCore / DentoCore Body is designed for dental core build-ups, which are used to restore and strengthen damaged or missing tooth structure before placing crowns or other restorations. It is preferred in these cases due to its high mechanical strength, minimal shrinkage during curing, and precise application through cartridges with mixing tips. Additionally, it includes fluoride release, which helps protect against future tooth decay, making it ideal for procedures requiring durable and protective restorations.
How is the DentoCore / DentoCore Body supplied, and what does this mean for ease of use in a clinical setting?
The DentoCore / DentoCore Body is supplied in cartridges that include both mixing and intraoral application tips, which streamlines the application process. This design eliminates the need for manual mixing, reduces waste, and allows for precise delivery directly into the oral cavity, improving efficiency and ease of use for clinicians during restorative procedures.
Is the DentoCore / DentoCore Body intended for single-use or can it be reused? How should it be stored to maintain its performance?
The DentoCore / DentoCore Body is intended for professional-use in dental procedures, but its specific reuse or single-use nature isn’t explicitly stated in the provided data. However, since it is supplied in sterile cartridges (implied by standard dental composite practices), it is typically designed for single-use to ensure sterility and performance. Storage must comply with the manufacturer’s instructions to preserve sterility and functionality, though no explicit sterility claims are made beyond this general guideline.
What regulatory pathways has the DentoCore / DentoCore Body followed, and what does this mean for its use in the U.S. and Europe?
The DentoCore / DentoCore Body holds FDA 510(k) clearance (K121769) under the Abbreviated pathway, meaning it was determined to be substantially equivalent to a legally marketed device. In Europe, it is classified as a Class IIa medical device under the MDD (Medical Device Directive), indicating it has undergone risk assessment and compliance evaluation. This means it is legally marketable in both regions under their respective regulatory frameworks, though clinicians should always verify current compliance statuses.
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: Dentocore Body - Dual-cure composite for core build-ups, Dentocore / Dentocore Body - ITENA CLINICAL, Dentocore / Dentocore Body - Delta Vision Medical, Itena Clinical | DentoCore Body | DCBODY-50 - surgimac.com
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 | K121769 | Class II | Active |
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Manufacturer
- Manufacturer
- Itena Clinical
Sources (3)
- FDA 510(k) K121769 24 fields · synced Sep 18, 2026
- FDA UDI 62674ff8-1bcd-4176-a73b-c822fd363297 33 fields · synced May 30, 2026
- EUDAMED 5a1d7682-44aa-4671-9451-985cfff48a54 61 fields · synced Jul 30, 2026