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Bondable Retainer and Space Maintainer

by American Orthodontics

510(k) K893483Ref 855-284H, 855-321, 855-288, 855-285H, 855-312

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K893483↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000120DD Basic UDI-DI Date28 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190746074806 UDI-DI Date24 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK893483 Date14 Jul 1989ClearedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Bondable Retainer
Generic Name
Orthodontic retainer
Model / Ref / Catalog
855-284H, 855-321, 855-288, 855-312, 855-285H
Primary DI / UDI-DI
00190746074806, 00190746074998, 00190746074851, 00190746074950, 00190746074820
Basic UDI-DI
01907460000120DD
510(k) Number
FDA Product Code
EJF 510(k)
DYT GUDID
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic retainer
Device Class
Class IIa EUDAMED
Class I 510(k)GUDID
Regulation
21 CFR Part 872.5410 510(k)
872.5525 GUDID
EU market of registration
Netherlands
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
—
510(k)
EJF
GUDID
DYT
Device ClassEUDAMED
Class IIa
510(k)
Class I
GUDID
Class I
Regulation NumberEUDAMED
—
510(k)
872.5410
GUDID
872.5525

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No