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FTN Tapered Drill DTH 3315S

by DIO Corporation

Ref DTH 3315S

FTN Tapered Drill DTH 3315S is a device classified as Class IIa in the EU and Class I in the US made by DIO Corporation, registered in EUDAMED on 25 Oct 2026 (Basic UDI-DI 880004925014B9) and listed in FDA GUDID since 1 Dec 2022 (UDI-DI 08800049304266), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880004925014B9 Basic UDI-DI 08800049304266UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800049304266 UDI-DI Date1 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880004925014B9 registered 25 Oct 2026 Active
  • FDA GUDID UDI-DI 08800049304266 listed 1 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800049304266
  2. Registered EUDAMED 880004925014B9

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  • Withdrawn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
FTN Tapered Drill
Generic name
Fixture/appliance dental drill bit, reusable
Device name
Dental Bone Preparation Drill
Model / reference
DTH 3315S
Primary DI / UDI-DI
08800049304266
Basic UDI-DI
880004925014B9
FDA product code
DZA
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
EU registration type
Standard device
EU market of registration
Netherlands
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 IIa
GUDID
Class I

Related devices

Category: Fixture/appliance dental drill bit, reusable

Other devices from DIO Corporation

See all devices from DIO Corporation →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)