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Reliabites

by Reliance Orthodontic Products, Inc. EUDAMEDGUDID

Active European Union

Ref RBYSORModel Orthodontic Accessories

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number840479ORTHOACCESSORIESBR Basic UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840479203096 UDI-DIDate11 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Reliabites EUDAMED
Reliabite Chewie Aligner Seater Y-Shaped Soft GUDID
Generic Name
Dental material mixing surface, chairside, single-use
Model / Reference
Orthodontic Accessories, RBYSOR
Primary DI / UDI-DI
00840479203096
Basic UDI-DI
840479ORTHOACCESSORIESBR
FDA Product Code
PFL
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental material mixing surface, chairside, single-use
Device Class
Class I
Regulation Number
872.6890
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000013812
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No