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Instrument P1 06067700

by W&H Dentalwerk Burmoos

Ref 06067700

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++J021S0003R6 Basic UDI-DI +J021060677001UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+J021060677001 UDI-DI Date18 Sep 2016ListedStatusListed 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  • Withdrawn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

Trade Name
P1 EUDAMED
Instrument P1 GUDID
Generic Name
Dental ultrasonic surgical system handpiece tip
Device Name
Piezo Instruments OCI
Model / Reference
06067700
Primary DI / UDI-DI
+J021060677001 EUDAMED
J021060677001 GUDID
Basic UDI-DI
++J021S0003R6
FDA Product Code
DZI, ELC
EMDN Code
Z12119099 Various dental stomatology instruments - other
GMDN Term
Dental ultrasonic surgical system handpiece tip
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.4120, 872.4850
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+J021060677001
GUDID
J021060677001
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No