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Spirapost 888100

by DMG America LLC

Spirapost 888100 is a Class I device made by DMG America LLC, cleared under FDA 510(k) K060075 on 30 Mar 2006 and listed in FDA GUDID since 9 Dec 2022 (UDI-DI D0338881001), active as of 22 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 22 Oct 2026

Documents

510(k) K060075

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0338881001 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060075 Date30 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060075 decided 30 Mar 2006 Active
  • FDA GUDID UDI-DI D0338881001 listed 9 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060075
  2. Listed FDA GUDID D0338881001

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spirapost
Generic name
Root canal post kit
Model / Ref / Catalog
888100
Primary DI / UDI-DI
D0338881001
510(k) Number
FDA product code
ELR
GMDN term
Root canal post kit
Device class
Class I
Regulation number
872.3810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Root canal post kit

Cleared under the same submission (K060075)

Other devices from DMG America LLC

See all devices from DMG America LLC →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)