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NA surgically Invasive Instruments

by Institut Straumann SA EUDAMEDGUDID

Active European Union and United States

Ref 027.0005S

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763003170003Q8 Basic UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630031732156 UDI-DIDate2 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Made available in 27 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 2 Oct 2017
  • Belgium since 2 Oct 2017
  • Bulgaria since 2 Oct 2017
  • Croatia since 2 Oct 2017
  • Cyprus since 2 Oct 2017
  • Czechia since 2 Oct 2017
  • Denmark since 2 Oct 2017
  • Estonia since 2 Oct 2017
  • Finland since 2 Oct 2017
  • France since 2 Oct 2017
  • Germany since 2 Oct 2017
  • Greece since 2 Oct 2017
  • Hungary since 2 Oct 2017
  • Ireland since 2 Oct 2017
  • Italy since 2 Oct 2017
  • Latvia since 2 Oct 2017
  • Lithuania since 2 Oct 2017
  • Luxembourg since 2 Oct 2017
  • Malta since 2 Oct 2017
  • Netherlands since 2 Oct 2017
  • Poland since 2 Oct 2017
  • Portugal since 2 Oct 2017
  • Romania since 2 Oct 2017
  • Slovakia since 2 Oct 2017
  • Slovenia since 2 Oct 2017
  • Spain since 2 Oct 2017
  • Sweden since 2 Oct 2017

Last checked 23 Oct 2026.

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Na
Generic Name
Fixture/appliance dental drill bit, single-use
Device Name
Surgically Invasive Instruments: Tap / Drill / Cylinder
Model / Ref / Catalog
027.0005S, surgically Invasive Instruments
Primary DI / UDI-DI
07630031732156
Basic UDI-DI
0763003170003Q8
FDA Product Code
NDP
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Fixture/appliance dental drill bit, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3980
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Size
Outer Diameter — 4.8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
027.0005S
GUDID
surgically Invasive Instruments
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Fixture/appliance dental drill bit, single-use

Other devices from Institut Straumann SA

See all devices from Institut Straumann SA →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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