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Dental Implant, ROOTT BS, D 3.5 mm, L 16 mm.

EUDAMED

Class IIb (EU MDR)

Ref B3516ssModel Dental implant, ROOTT BS

by Trate Ag

Identity

Trade Name
Dental Implant, ROOTT BS, D 3.5 mm, L 16 mm. EUDAMED
Model / Reference
Dental implant, ROOTT BS EUDAMED
B3516ss EUDAMED

Identifiers

Primary DI / UDI-DI
17630053808300 EUDAMED
17630053804197 EUDAMED
Basic UDI-DI
76300538ROOTTBS2F EUDAMED
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Dental Implant, ROOTT BS, D 3.5 mm, L 16 mm. by Trate Ag — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Trate Ag
EUDAMED SRN
CH-MF-000019071
Authorised Representative
Trate UAB LT-AR-000002509

Sources (2)

  • EUDAMED f253624c-74b2-48ce-8ca9-5767b85367dd 61 fields · synced Jun 20, 2026
  • EUDAMED 18ac04e1-2c6d-4115-9721-7f01f51e366e 61 fields · synced May 11, 2026