← Back to catalogue
Base·it
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref #816101Ref #816104510(k) K134022Ref #816102Ref Κ395
by Spident
Identity
- Trade Name
- Base·it EUDAMEDBase EUDAMEDBase It FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Base·it EUDAMEDLight-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer. FDA UDI
- Model / Reference
- #816101 EUDAMED#816104 EUDAMED#816102 EUDAMEDΚ395 EUDAMED101-0101 FDA UDI
- Description
- Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer. FDA UDI
Identifiers
- Catalog Number
- 101-0101 FDA UDI
- Primary DI / UDI-DI
- 08809262954531 EUDAMED08809262954517 EUDAMED08809262954524 EUDAMEDFDA UDI08809911112305 EUDAMED
- Basic UDI-DI
- B-08809262954531 EUDAMEDB-08809262954517 EUDAMEDB-08809262954524 EUDAMED880926295BIZL EUDAMED
- Direct Marketing DI
- 08809262954517 EUDAMED08809911112305 EUDAMED08809262954531 EUDAMED
- 510(k) Number
- K134022 FDA 510(k)
- FDA Product Code
- EJK FDA 510(k)FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS 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 872.3250 FDA 510(k)
- Regulation Number
- 872.3250 FDA 510(k)FDA UDI
- Market of Registration
- Bulgaria EUDAMEDNetherlands 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Base·it by Spident — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809262954531 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K134022 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262954531 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (8)
- EUDAMED 30c81970-4996-4210-9b12-2828314f16ba 61 fields · synced Aug 3, 2026
- EUDAMED d61d35ec-1949-40f2-962f-fb4aa67e429b 61 fields · synced May 18, 2026
- FDA 510(k) K134022 24 fields · synced May 18, 2026
- FDA UDI 7f7359e6-caa3-475d-9f98-0581aa0e0017 35 fields · synced May 30, 2026
- EUDAMED 148ed1a0-a3d9-4d60-a714-fa07ac8615de 61 fields · synced Jul 9, 2026
- EUDAMED b66bcdd4-dcc9-43e8-975a-514f60363d26 61 fields · synced Jul 11, 2026
- EUDAMED 8afdef80-ef28-4181-9932-2fa18ffead3b 61 fields · synced Jul 14, 2026
- EUDAMED 9731f962-e4ae-4d06-81dc-f763eea6a38a 61 fields · synced Aug 3, 2026