Denture Base II
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Dentca, Inc.
Identity
- Trade Name
- DENTCA Denture Base II EUDAMEDDENTCA Denture Base FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- DENTCA Denture Base II - Original Pink - 1kg FDA UDIDENTCA Denture Base II - Reddish Pink - 1kg FDA UDI
- Model / Reference
- Denture Base II EUDAMED01303 EUDAMED01302 EUDAMEDDENTCA Denture Base II FDA UDI
- Description
- DENTCA Denture Base II - Original Pink - 1kg FDA UDIDENTCA Denture Base II - Reddish Pink - 1kg FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856551007247 EUDAMEDFDA UDI00856551007261 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856551007261 EUDAMEDB-00856551007247 EUDAMED
- 510(k) Number
- K162044 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)FDA UDI
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 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
Yes
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Weight — 1 Kilogram FDA UDI
The Denture Base II is a dental prosthetic device classified as a denture base under the FDA’s Dental Product Classification. It serves as the foundational structure for removable partial or complete dentures, providing stability, support, and an anatomical fit for the oral cavity. Constructed to mimic natural gum tissue, it ensures comfort and functionality for patients while accommodating various dental restorations.
This device is supplied as a reusable component, intended for use in dental laboratories and clinical settings by trained professionals. It is not sterile at time of shipment and must be processed according to standard dental laboratory protocols before patient application. The product is authorised under FDA 510K clearance (K162044) and complies with the Medical Device Directive (MDD). Sizes and modifications are tailored to individual patient requirements as determined by dental technicians.
Frequently asked questions
Is the Denture Base II designed for single-use or can it be reused after processing?
The Denture Base II is intended for reuse by dental laboratories and clinical settings. Since it is not sterile at shipment, it must be processed according to standard dental laboratory protocols before being used with patients. This reusable design allows for customization and modifications tailored to individual patient needs as determined by trained dental technicians.
How is the Denture Base II customized to fit patients, and what types of dentures can it support?
The Denture Base II is designed as a foundational structure for both removable partial and complete dentures. Its construction mimics natural gum tissue to ensure comfort and stability. Customization occurs through adjustments made by dental technicians based on individual patient requirements, allowing it to accommodate various dental restorations while providing an anatomical fit for the oral cavity.
What steps must be taken to prepare the Denture Base II for patient use, given it is not sterile upon receipt?
Since the Denture Base II is not sterile at shipment, it must undergo standard dental laboratory processing before being applied to a patient. This includes cleaning, sterilization, and any necessary adjustments to ensure safety and proper fit. The device is intended for use only by trained professionals in controlled settings, such as dental labs or clinics.
What regulatory pathways does the Denture Base II follow, and how does this affect its use?
The Denture Base II is authorized under FDA 510K clearance (K162044) and complies with the Medical Device Directive (MDD). This means it has undergone evaluation by the FDA to demonstrate substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness. Clinicians and labs can rely on this clearance when incorporating the device into their workflow, though local sterilization and processing remain the responsibility of the facility.
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.
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 | K162044 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentca, Inc.
Sources (5)
- FDA 510(k) K162044 24 fields · synced Sep 18, 2026
- FDA UDI 33360bdc-fead-4123-9af4-a582405d1b75 36 fields · synced May 30, 2026
- FDA UDI b7e01288-0791-45b9-ba1b-3dcdb6eb7500 36 fields · synced May 30, 2026
- EUDAMED 4f68c094-9976-4537-81e7-cde00ee1c2f0 61 fields · synced Jul 9, 2026
- EUDAMED c732707b-de6a-4aeb-8a5f-352c111496b2 61 fields · synced Jul 19, 2026