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e-Space Maintainer SM-MK

by Kids-E-Dental Llp

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08906154843116 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
e-Space Maintainer
Generic Name
Orthodontic space maintainer
Model / Reference
SM-MK
Description
All in one Master Kit, Kit - 74 Band & 80 Loops Band Size from 24 to 42 - 2 each. Straight loop - 30 loop Curved loop - 30 loop Distal shoe loop - 20 loop
Primary DI / UDI-DI
08906154843116
FDA Product Code
DYT
GMDN Term
Orthodontic space maintainer
Device Class
Class I
Regulation Number
872.5525
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Kids-E-Dental Llp

See all devices from Kids-E-Dental Llp →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No