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Tera Harz Hard Denture Thd-P-500

by Graphy Inc.

Tera Harz Hard Denture Thd-P-500 is a Class II device made by Graphy Inc., cleared under FDA 510(k) K253681 on 21 Nov 2025 and listed in FDA GUDID since 3 Dec 2025 (UDI-DI 08800142100444), 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) K253681

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 Number08800142100444 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253681 Date21 Nov 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253681 decided 21 Nov 2025 Active
  • FDA GUDID UDI-DI 08800142100444 listed 3 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253681
  2. Listed FDA GUDID 08800142100444

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tera Harz Hard Denture
Generic name
Dental appliance fabrication material, resin
Model / reference
THD-P-500
Primary DI / UDI-DI
08800142100444
510(k) Number
FDA product code
EBI
GMDN term
Dental appliance fabrication material, resin
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253681)

Other devices from Graphy Inc.

See all devices from Graphy Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)