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Dynamic TiBase - Dynamic TiBase

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K241170Ref 31.323.022.05-2Model DTIBASE01

by Talladium España Sl

Identity

Trade Name
DYNAMIC ABUTMENT SOLUTIONS FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
TiBase® EUDAMED
Non-engaging Dynamic Ti-Base G5 Comp.0022 FDA UDI
Model / Reference
31.323.022.05-2 EUDAMEDFDA UDI
DTIBASE01 EUDAMED
Description
Non-engaging Dynamic Ti-Base G5 Comp.0022 FDA UDI

Identifiers

Primary DI / UDI-DI
08436568739816 EUDAMEDFDA UDI
Basic UDI-DI
843656873DTIBASEZ7 EUDAMED
510(k) Number
K241170 FDA 510(k)
K232151 FDA UDI
FDA Product Code
NHA FDA 510(k)FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI
Models / Variants
Dynamic TiBase FDA 510(k)FDA UDIEUDAMED
TRI Screws FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)FDA UDI
Market of Registration
Spain 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

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

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

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dynamic TiBase - Dynamic TiBase by Talladium España Sl — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — 2 models

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Talladium España Sl
FDA Applicant
Talladium España, SL

Sources (3)

  • FDA 510(k) K241170 24 fields · synced Sep 30, 2026
  • FDA UDI 2cf55348-c287-41bb-81a5-e084f2fa2670 36 fields · synced May 30, 2026
  • EUDAMED 11e486be-ea56-4548-8a28-142870c8ba90 61 fields · synced Sep 30, 2026