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Silginat Strawberry Bulk pack

by Kettenbach GmbH & Co. KG 2 variants

Ref 13827Model Silginat

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E217IMPSILGINATMH Basic UDI-DI E217138271UDI-DIDate5 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberE217138271 UDI-DI Date12 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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

Trade Name
Silginat Strawberry Bulk pack EUDAMED
Silginat GUDID
Generic Name
Silicone dental impression material
Model / Ref / Catalog
Silginat, 13827
Primary DI / UDI-DI
E217138271
Basic UDI-DI
++E217IMPSILGINATMH
510(k) Number
FDA Product Code
ELW
EMDN Code
Q01020199 Dental impression materials - other
GMDN Term
Silicone dental impression material
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005014

Related devices

Category: Silicone dental impression material

Other devices from Kettenbach GmbH & Co. KG

See all devices from Kettenbach GmbH & Co. KG →

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