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EdgeTaper Blaze Utopia S2 L21 Sterile

by Micro Mega

Ref ETBUS221SModel EdgeTaper Blaze Utopia

EdgeTaper Blaze Utopia S2 L21 Sterile (ETBUS221S) is a device classified as Class IIa in the EU and Class I in the US made by Micro Mega, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI B-03701310370100) and listed in FDA GUDID since 29 Sep 2023 (UDI-DI 03701310370100), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03701310370100 Basic UDI-DI 03701310370100UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701310370100 UDI-DI Date29 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03701310370100 registered 12 Oct 2026 Active
  • FDA GUDID UDI-DI 03701310370100 listed 29 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03701310370100
  2. Registered EUDAMED B-03701310370100

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
EdgeTaper Blaze Utopia
Generic name
Rotary/reciprocating endodontic file/rasp, single-use
Model / Ref / Catalog
EdgeTaper Blaze Utopia, ETBUS221S, S2 L21 Sterile
Primary DI / UDI-DI
03701310370100
Basic UDI-DI
B-03701310370100
FDA product code
EKS
EMDN code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN term
Rotary/reciprocating endodontic file/rasp, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
EdgeTaper Blaze Utopia
ETBUS221S
GUDID
S2 L21 Sterile
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 03701310370100: 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: Rotary/reciprocating endodontic file/rasp, single-use

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTISTRY, SINGLE-USE.

Other devices from Micro Mega

See all devices from Micro Mega →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)