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G-Cam GC00007

by Graphenano Dental Sl.

Ref GC00007Model G-CAM

G-Cam GC00007 is a device classified as Class IIa in the EU and Class II in the US made by Graphenano Dental Sl., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-08445644000696), cleared under FDA 510(k) K220329 on 16 Aug 2022 and listed in FDA GUDID since 21 Oct 2022 (UDI-DI 08445644000696), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220329

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08445644000696 Basic UDI-DI 08445644000696UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08445644000696 UDI-DI Date21 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK220329 Date16 Aug 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08445644000696 registered 3 Nov 2026 Active
  • FDA 510(k) K220329 decided 16 Aug 2022 Active
  • FDA GUDID UDI-DI 08445644000696 listed 21 Oct 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1192-2024 FDA Class II initiated 24 Oct 2023

    Machining error on cams renders the device unusable.

Timeline

4 dated events

  1. Cleared FDA 510(k) K220329
  2. Listed FDA GUDID 08445644000696
  3. Recall initiated FDA recalls Z-1192-2024
  4. Registered EUDAMED B-08445644000696

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
G-Cam
Generic name
Dental appliance fabrication material, thermoplastic
Model / reference
GC00007, G-CAM
Primary DI / UDI-DI
08445644000696
Basic UDI-DI
B-08445644000696
510(k) Number
FDA product code
EBF, EBG, EBI
EMDN code
Q01020601, Q01020602, Q01020605
GMDN term
Dental appliance fabrication material, thermoplastic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690, 872.3770, 872.3760
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental appliance fabrication material, thermoplastic

Cleared under the same submission (K220329)

and 8 more cleared under K220329

Similar devices in this category

Other devices filed under MOBILE DENTAL PROSTHESES.

Other devices from Graphenano Dental Sl.

  • G-Block GB00001

    Class II

  • G-Block GB00002

    Class II

  • G-Block GB00003

    Class II

  • G-Block GB00004

    Class II

See all devices from Graphenano Dental Sl. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)