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Prosthetic screw UniGrip™ Novum 2-pack

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 27257

by Nobel Biocare AB

Identity

Trade Name
Prosthetic screw UniGrip™ Novum 2-pack EUDAMED
Nobel Biocare® FDA UDI
Generic Name
Dental prosthesis/implant abutment screw FDA UDI
Device Name
Standardized abutment screws EUDAMED
Prosthetic screw UniGrip™ Novum 2-pack FDA UDI
Model / Reference
27257 EUDAMEDFDA UDI
Description
Prosthetic screw UniGrip™ Novum 2-pack FDA UDI

Identifiers

Catalog Number
27257 FDA UDI
Primary DI / UDI-DI
07332747207897 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001837D EUDAMED
Unit of Use DI
07332747150384 EUDAMED
FDA Product Code
NHA FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental prosthesis/implant abutment screw 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

Prosthetic screw UniGrip™ Novum 2-pack 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

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (2)

  • EUDAMED 1648861d-2e78-461b-964f-1e857190da0f 61 fields · synced Jul 22, 2026
  • FDA UDI da6ae304-7471-44f1-a498-80e709e4ccb5 36 fields · synced May 30, 2026