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Surgical Instrument Exr 01

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref EXR 01Model SURGICAL INSTRUMENT

Surgical Instrument Exr 01 is a device classified as Class I in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 23 May 2026 (Basic UDI-DI 999520000027K2), cleared under FDA 510(k) K201688 on 21 Oct 2020 and listed in FDA GUDID since 22 Mar 2021 (UDI-DI 07899995207289), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201688

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000027K2 Basic UDI-DI 07899995207289UDI-DIDate23 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995207289 UDI-DI Date22 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201688 Date21 Oct 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000027K2 registered 23 May 2026 Active
  • FDA 510(k) K201688 decided 21 Oct 2020 Active
  • FDA GUDID UDI-DI 07899995207289 listed 22 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201688
  2. Listed FDA GUDID 07899995207289
  3. Registered EUDAMED 999520000027K2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Rotary Expander N° 01 EUDAMED
Surgical Instrument GUDID
Generic name
Dental osteotome
Device name
Rotary Expander
Model / Ref / Catalog
EXR 01, SURGICAL INSTRUMENT
Primary DI / UDI-DI
07899995207289
Basic UDI-DI
999520000027K2
510(k) Number
FDA product code
KCT
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Dental osteotome
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental osteotome

Cleared under the same submission (K201688)

and 8 more cleared under K201688

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)