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NA Non-invasive Instruments

by Institut Straumann SA 9 variants

Ref 046.795

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

This dental implant x-ray template is designed to provide a precise measurement of the appropriate size of a mini implant for optimal placement in the jawbone. Made from high-quality translucent plastic, it features graduated markings and can be used individually or as part of a set with multiple sheets to ensure accurate measurements.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763003170010Q5 Basic UDI-DI 07630031739551UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630031739551 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental implant x-ray template
Device Name
X-ray Template/Folio
Model / Ref / Catalog
046.795, Non-invasive Instruments
Primary DI / UDI-DI
07630031739551
Basic UDI-DI
0763003170010Q5
FDA Product Code
NDP
EMDN Code
Z119099 Various bioimaging and radiotherapy instruments - other
GMDN Term
Dental implant x-ray template
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
046.795
GUDID
Non-invasive Instruments

Related devices

Category: Dental implant x-ray template

Other devices from Institut Straumann SA

See all devices from Institut Straumann SA →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No