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Self Mixing Crown Lok 1SMCLB

by Reliance Orthodontic Products, Inc.

Ref 1SMCLBModel Chemical Cure Orthodontic Adhesives

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number840479ADHESIVECHEMCUREUE Basic UDI-DI 00840479200644UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840479200644 UDI-DI Date23 Feb 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Crown Lok EUDAMED
Self Mixing Crown Lok GUDID
Generic Name
Orthodontic bracket adhesive
Model / Reference
1SMCLB, Chemical Cure Orthodontic Adhesives
Primary DI / UDI-DI
00840479200644
Basic UDI-DI
840479ADHESIVECHEMCUREUE
FDA Product Code
EBF
EMDN Code
Q010407 Orthodontic cements
GMDN Term
Orthodontic bracket adhesive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3690
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No