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Jet Set-4 Tooth Shade Powder

by Lang Dental Manufacturing Company, Inc.

Ref 3810FR62

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D650146Z Basic UDI-DI D6503810FR620UDI-DIDate21 Jan 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD6503810FR620 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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 GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Temporary dental crown/bridge resin
Device Name
Provisional Crown and Bridge Acrylic
Model / Ref / Catalog
3810FR62 EUDAMED
11.3 KG SHADE OM1 GUDID
3870OM1 GUDID
Primary DI / UDI-DI
D6503810FR620 EUDAMED
D6503870OM10 GUDID
Basic UDI-DI
++D650146Z
510(k) Number
FDA Product Code
EBG
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Temporary dental crown/bridge resin
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3770
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
3810FR62
GUDID
11.3 KG SHADE OM1
Primary DI / UDI-DIEUDAMED
D6503810FR620
GUDID
D6503870OM10
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003646
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

From the manufacturer

Manufacturer's product page: Jet Set-4™

Other devices from Lang Dental Manufacturing Company, Inc.

See all devices from Lang Dental Manufacturing Company, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

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