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Orthodontic Spring NT15-8H

by DENTOS Inc.

Ref NT15-8H

Orthodontic Spring NT15-8H is a device classified as Class IIa in the EU and Class I in the US made by DENTOS Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 88061454AMS003G4) and listed in FDA GUDID since 16 Jul 2018 (UDI-DI 08806145420022), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88061454AMS003G4 Basic UDI-DI 08806145420022UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806145420022 UDI-DI Date16 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88061454AMS003G4 registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 08806145420022 listed 16 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806145420022
  2. Registered EUDAMED 88061454AMS003G4

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  • Withdrawn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
Orthodontic Spring
Generic name
Orthodontic spring
Device name
NT Coil Spring
Model / reference
NT15-8H
Primary DI / UDI-DI
08806145420022
Basic UDI-DI
88061454AMS003G4
Unit of use DI
08806145420312
FDA product code
ECO
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic spring
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Poland
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: Orthodontic spring

Other devices from DENTOS Inc.

See all devices from DENTOS Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)