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Tapered Pilot Drill VPLTT

by Versah, LLC

Ref VPLTTModel Densah Tapered Pilot Drills

Tapered Pilot Drill VPLTT is a device classified as Class IIa in the EU and Class I in the US made by Versah, LLC, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 0850017652DensahTPZ4) with CE/MDR certificate 1000272589 valid until 12 Aug 2031 and listed in FDA GUDID since 17 Apr 2020 (UDI-DI 00850017652125), active as of 23 Oct 2026.

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

CE MDR

Valid until

12 Aug 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000272589 Date10 Sep 2026IssuedStatusActive expires 12 Aug 2031
United StatesGUDID listing GUDID Number00850017652125 UDI-DI Date17 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850017652DensahTPZ4 registered 19 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850017652125 listed 17 Apr 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000272589 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    10 Sep 2026
    Expires
    12 Aug 2031

Timeline

4 dated events

  1. Listed FDA GUDID 00850017652125
  2. Registered EUDAMED 0850017652DensahTPZ4
  3. Certificate issued EUDAMED 1000272589
  4. Certificate expires EUDAMED 1000272589

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  • Withdrawn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
Pilot Drill G3 EUDAMED
Tapered Pilot Drill GUDID
Generic name
Orthopaedic bur, reusable
Model / reference
VPLTT, Densah Tapered Pilot Drills
Primary DI / UDI-DI
00850017652125
Basic UDI-DI
0850017652DensahTPZ4
FDA product code
EJL
EMDN code
L150101 Odontostomatology osteotomes, reusable
GMDN term
Orthopaedic bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3240
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00850017652125: EUDAMED states Yes, FDA GUDID states No.

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

Related devices

Category: Orthopaedic bur, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE.

Other devices from Versah, LLC

  • Densah Bur Holder VBLK

    Class I

  • VT1525-G

    Class I

  • VT4555-Gs

    Class I

  • VT1525-Gs

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See all devices from Versah, LLC →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)