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Replace Select™ TC RP 4.0x(10+3)mm

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 36290

by Nobel Biocare AB

Identity

Trade Name
Replace Select™ TC RP 4.0x(10+3)mm EUDAMED
Replace Select™ FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Straight implants EUDAMED
Replace Select™ TC RP 4.0x(10+3)mm FDA UDI
Model / Reference
36290 EUDAMEDFDA UDI
Description
Replace Select™ TC RP 4.0x(10+3)mm FDA UDI

Identifiers

Catalog Number
36290 FDA UDI
Primary DI / UDI-DI
07332747160420 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001266Z EUDAMED
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 10.000 Millimeter FDA UDI
Outer Diameter — 4.000 Millimeter FDA UDI
Height — 3.000 Millimeter FDA UDI

Replace Select™ TC RP 4.0x(10+3)mm by Nobel Biocare AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (2)

  • EUDAMED 583efb1a-49bf-4903-be33-9777884a532e 61 fields · synced Jul 10, 2026
  • FDA UDI 52aaecad-bf44-4cf4-a72e-e8361a3c4698 37 fields · synced May 30, 2026