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G-Block GB00002

by Graphenano Dental Sl.

G-Block GB00002 is a Class II device made by Graphenano Dental Sl., cleared under FDA 510(k) K253236 on 29 Sep 2025 and listed in FDA GUDID since 13 Jan 2026 (UDI-DI 08445644003222), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K253236

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08445644003222 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK253236 Date29 Sep 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253236 decided 29 Sep 2025 Active
  • FDA GUDID UDI-DI 08445644003222 listed 13 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253236
  2. Listed FDA GUDID 08445644003222

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
G-Block
Generic name
Dental appliance fabrication material, thermoplastic
Model / reference
GB00002
Primary DI / UDI-DI
08445644003222
510(k) Number
FDA product code
EBF, EBG
GMDN term
Dental appliance fabrication material, thermoplastic
Device class
Class II
Regulation number
872.3690, 872.3770
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253236)

and 8 more cleared under K253236

Other devices from Graphenano Dental Sl.

  • G-Block GB00001

    Class II

  • G-Block GB00003

    Class II

  • G-Block GB00004

    Class II

  • G-Block GB00005

    Class II

See all devices from Graphenano Dental Sl. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)