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Universal Abutment Nobel Biocare N1™ Base Tri RP

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 301007

by Nobel Biocare AB

Identity

Trade Name
Universal Abutment Nobel Biocare N1™ Base Tri RP EUDAMED
Nobel Biocare N1™ FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Multi-unit prosthetic abutments EUDAMED
Universal Abutment Nobel Biocare N1™ Base Tri RP FDA UDI
Model / Reference
301007 EUDAMEDFDA UDI
Description
Universal Abutment Nobel Biocare N1™ Base Tri RP FDA UDI

Identifiers

Catalog Number
301007 FDA UDI
Primary DI / UDI-DI
07332747214307 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001687H EUDAMED
FDA Product Code
PNP FDA UDI
NHA FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Market of Registration
Sweden EUDAMED
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
MRI Safety
MR Conditional FDA UDI

Universal Abutment Nobel Biocare N1™ Base Tri RP by Nobel Biocare AB — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

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 3d83ebff-f190-4068-b96f-12cf04f76ec4 61 fields · synced Jul 14, 2026
  • FDA UDI 6d8f5a52-88f5-4f18-96c9-a6175f2c9b13 36 fields · synced May 30, 2026
  • FDA 510(k) K180899 1 fields · synced May 18, 2026