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Guided Template Abutment w Screw Bmk Syst RP

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 32804

by Nobel Biocare AB

Identity

Trade Name
Guided Template Abutment w Screw Bmk Syst RP EUDAMED
Brånemark System® FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Device Name
Guided tools for osteotomy EUDAMED
Guided Template Abutment w Screw Bmk Syst RP FDA UDI
Model / Reference
32804 EUDAMEDFDA UDI
Description
Guided Template Abutment w Screw Bmk Syst RP FDA UDI

Identifiers

Catalog Number
32804 FDA UDI
Primary DI / UDI-DI
07332747209686 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001346Y EUDAMED
Direct Marketing DI
07332747007268 EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - 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

Yes

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 Template Abutment w Screw Bmk Syst RP 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 a6046c6b-95c1-4a76-aa85-dacc235ef2e5 61 fields · synced Jul 18, 2026
  • FDA UDI ae814310-dd88-4fca-a453-83e4cd212a1c 36 fields · synced May 30, 2026