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ZenSplint 024

by Modern Dental Laboratory (DG) Co., Ltd.

ZenSplint 024 is a device classified as Not classified made by Modern Dental Laboratory (DG) Co., Ltd., listed in FDA GUDID since 28 Apr 2026 (UDI-DI 06972677870245), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06972677870245 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ZenSplint
Generic name
Orthodontic retainer
Model / reference
024
Primary DI / UDI-DI
06972677870245
FDA product code
NSR
GMDN term
Orthodontic retainer
Device class
N
GUDID distribution status
In Commercial Distribution

Other devices from Modern Dental Laboratory (DG) Co., Ltd.

See all devices from Modern Dental Laboratory (DG) Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)