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Regular Glide-Ties 300-201

by Ortho Arch Company

Ref 300-201Model REGULAR GLIDE-TIES CLEAR (1,008)

Regular Glide-Ties 300-201 is a device classified as Class IIa in the EU and Class I in the US made by Ortho Arch Company, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-+D9093002011-) and listed in FDA GUDID since 27 Aug 2021 (UDI-DI +D9093002011-), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D9093002011- Basic UDI-DI +D9093002011-UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D9093002011- UDI-DI Date27 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+D9093002011- registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI +D9093002011- listed 27 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +D9093002011-
  2. Registered EUDAMED B-+D9093002011-

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  • Withdrawn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
Regular Glide-Ties
Generic name
Orthodontic inter-arch elastic band
Model / Ref / Catalog
300-201, REGULAR GLIDE-TIES CLEAR (1, 008)
Primary DI / UDI-DI
+D9093002011- EUDAMED
D9093002011 GUDID
Basic UDI-DI
B-+D9093002011-
FDA product code
ECI
EMDN code
Q010406 Orthodontic ligatures
GMDN term
Orthodontic inter-arch elastic band
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+D9093002011-
GUDID
D9093002011
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D9093002011-; FDA GUDID lists D9093002011), so their flags are not compared. 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.

From the manufacturer

Manufacturer's product page: Regular Glide-Ties $29.85 – $245.00Price range: $29.85 through $245.00

Related devices

Category: Orthodontic inter-arch elastic band

Similar devices in this category

Other devices filed under ORTHODONTIC LIGATURES.

Other devices from Ortho Arch Company

See all devices from Ortho Arch Company →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)