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NobelActive® 3.0 3.0x11.5mm

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 36770

by Nobel Biocare AB

Identity

Trade Name
NobelActive® 3.0 3.0x11.5mm EUDAMED
NobelActive® FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
NobelActive Implants EUDAMED
NobelActive® 3.0 3.0x11.5mm FDA UDI
Model / Reference
36770 EUDAMEDFDA UDI
Description
NobelActive® 3.0 3.0x11.5mm FDA UDI

Identifiers

Catalog Number
36770 FDA UDI
Primary DI / UDI-DI
07332747160611 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001216P 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

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.000 Millimeter FDA UDI
Length — 11.500 Millimeter FDA UDI

NobelActive® 3.0 3.0x11.5mm by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (3)

  • EUDAMED ade4d619-f71a-4b6a-81ee-f16f74066d2c 61 fields · synced Jul 18, 2026
  • FDA UDI 502841ef-ddb0-4c47-8ed2-ea93fd28c073 37 fields · synced May 30, 2026
  • FDA 510(k) K102436 1 fields · synced May 18, 2026