Skip to content

DD Bio Splint P HI 98H15

by Dental Direkt GmbH

Ref K40115

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDDIPOLYMER1209IIARC Basic UDI-DI EDDIK401151UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEDDIK401151 UDI-DI Date5 May 2017ListedStatusListed 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  • Withdrawn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
DD Bio Splint P HI 98H15 EUDAMED
DD Bio Splint P HI GUDID
Generic Name
Dental appliance fabrication material, thermoplastic
Device Name
DD medical polymers 1209
Model / Ref / Catalog
K40115, 98H15
Primary DI / UDI-DI
EDDIK401151
Basic UDI-DI
++EDDIPOLYMER1209IIARC
FDA Product Code
MQC
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class IIa EUDAMED
U GUDID
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Height — 15 Millimeter
Outer Diameter — 98.5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
K40115
GUDID
98H15
Device ClassEUDAMED
Class IIa
GUDID
U

Related devices

Category: Dental appliance fabrication material, thermoplastic

Other devices from Dental Direkt GmbH

See all devices from Dental Direkt GmbH →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Premarket Exempt: No
  • Serial Number: No