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Guided Cylinder w Pin Unigrip Bmk Syst NP

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 32768

by Nobel Biocare AB

Identity

Trade Name
Guided Cylinder w Pin Unigrip Bmk Syst NP EUDAMED
Brånemark System® FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Device Name
Lab tools for surgical templates EUDAMED
Guided Cylinder w Pin Unigrip Bmk Syst NP FDA UDI
Model / Reference
32768 EUDAMEDFDA UDI
Description
Guided Cylinder w Pin Unigrip Bmk Syst NP FDA UDI

Identifiers

Catalog Number
32768 FDA UDI
Primary DI / UDI-DI
07332747209594 EUDAMEDFDA UDI
Basic UDI-DI
733274700000020874 EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
GMDN Term
Dental implant suprastructure, temporary, preformed, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.3980 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

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

Yes

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

Guided Cylinder w Pin Unigrip Bmk Syst NP by Nobel Biocare AB — Class I — 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 3fd67fcf-db58-4df2-b08a-08883645961a 61 fields · synced Jul 19, 2026
  • FDA UDI d63df7be-ac0c-478e-9ec8-462f74e23cab 36 fields · synced May 30, 2026