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Pro-Form Splint Material

by Keystone Industries 2 variants

Ref 9614860R1

Pro-Form Splint Material (9614860R1) is a Class I device made by Keystone Industries, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI B-++H6689614860R11), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++H6689614860R11 Basic UDI-DI ++H6689614860R11UDI-DIDate8 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Splint Material
Model / reference
9614860R1
Primary DI / UDI-DI
++H6689614860R11
Basic UDI-DI
B-++H6689614860R11
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000020203
Authorised representative
KEYSTONE Europe BV NL-AR-000010443

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

Other properties (12, all answered No)