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Proform 9614956

by Keystone Industries

Ref 9614956

Proform 9614956 is a Class I device made by Keystone Industries, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI B-++H66896149561) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI ++H66896149561), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-++H66896149561 Basic UDI-DI ++H66896149561UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++H66896149561 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-++H66896149561 registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI ++H66896149561 listed 30 Nov 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID ++H66896149561
  2. Registered EUDAMED B-++H66896149561

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pro-Form Splint Material EUDAMED
Proform GUDID
Generic name
Dental appliance fabrication material, thermoplastic
Device name
Splint Material
Model / Ref / Catalog
9614956
Primary DI / UDI-DI
++H66896149561 EUDAMED
H66896149561 GUDID
Basic UDI-DI
B-++H66896149561
FDA product code
KMY
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, thermoplastic
Device class
Class I
Regulation number
872.5525
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++H66896149561
GUDID
H66896149561

The registries describe this device under different primary UDI-DIs (EUDAMED lists ++H66896149561; FDA GUDID lists H66896149561), so their flags are not compared.

Related devices

Category: Dental appliance fabrication material, thermoplastic

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

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)