Skip to content

MEDENTiKA R 400

by MEDENTiKA GmbH

Ref C 14-4311, 1-33-01, 5-13-01Model PROCONE surgical drill, Rescue-Kit, Placement instrument

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 Number42515748PSD006GC Basic UDI-DI Date29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251574806994 UDI-DI Date30 Oct 2015ListedStatusListed 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  • Withdrawn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
MEDENTiKA
Generic Name
Dental implant suprastructure, permanent, preformed
Surgical drill guide, single-use
Surgical screwdriver, reusable
Model / Ref / Catalog
1-33-01, 5-13-01, PROCONE surgical drill, C 14-4311, Rescue-Kit, Placement instrument, R 400
Primary DI / UDI-DI
04251574806994 EUDAMED
04251574833693 EUDAMED
04251574840394 EUDAMED
EMKAR400 GUDID
EMKA133019 GUDID
EMKA513019 GUDID
Basic UDI-DI
42515748PSD006GC, 42515748RES005FK, 42515748PLA002D2
510(k) Number
FDA Product Code
NHA, NDP
EMDN Code
L159099, Q010599
GMDN Term
Dental implant suprastructure, permanent, preformed
Surgical drill guide, single-use
Surgical screwdriver, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3630, 872.3980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04251574806994
04251574833693
04251574840394
GUDID
EMKAR400
EMKA133019
EMKA513019
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class I
Class II
ImplantableEUDAMED
No
GUDID
No
Yes

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K142167)

Show all (12)

Other devices from MEDENTiKA GmbH

See all devices from MEDENTiKA GmbH →

Properties

  • Single Use YesGUDIDNoGUDID
  • Implantable NoEUDAMEDGUDIDYesGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use YesGUDIDNoGUDID
  • Convenience Kit YesGUDIDNoGUDID
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Manufacturing Date NoGUDIDYesGUDID

Other properties (16)

  • Sterile: 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No