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Get Sculpted 26-310

by Pascal Company, Inc.

Part of a family of 13 devices: see the family page

Ref 26310

Get Sculpted 26-310 is a dental wax carver (EU MDR Class I; FDA Class I; FDA product code EIK, Carver, Wax, Dental) made by Pascal Company, Inc., registered in EUDAMED on 7 May 2024 (Basic UDI-DI 03108669002HH) and listed in FDA GUDID since 16 May 2024 (UDI-DI 00310866002644), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00310866002644 UDI-DI Date16 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number03108669002HH Basic UDI-DI 00310866002644UDI-DIDate7 May 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03108669002HH registered 7 May 2024 Active
  • FDA GUDID UDI-DI 00310866002644 listed 16 May 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 03108669002HH
  2. Listed FDA GUDID 00310866002644

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  • Withdrawn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
"Get Sculpted" Wax Carving Set EUDAMED
Get Sculpted GUDID
Generic name
Dental wax carver
Device name
Generic Devices
Model / Ref / Catalog
26310 EUDAMED
26-310 GUDID
Primary DI / UDI-DI
00310866002644
Basic UDI-DI
03108669002HH
FDA product code
EIK
EMDN code
Q010280 Prosthetic dentistry devices - accessories
GMDN term
Dental wax carver
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
26310
GUDID
26-310
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00310866002644: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Dental wax carver

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - ACCESSORIES.

Other devices from Pascal Company, Inc.

See all devices from Pascal Company, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Premarket exempt
Other properties (23, all answered No)