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EsBond Activator 101-0502

by Spident Co., Ltd.

EsBond Activator 101-0502 is a Class II device made by Spident Co., Ltd., cleared under FDA 510(k) K092572 on 26 Aug 2009 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI 08809262955439), 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) K092572

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 Number08809262955439 UDI-DI Date21 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092572 Date26 Aug 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092572 decided 26 Aug 2009 Active
  • FDA GUDID UDI-DI 08809262955439 listed 21 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092572
  2. Listed FDA GUDID 08809262955439

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EsBond Activator
Generic name
Dental composite resin
Model / Ref / Catalog
101-0502
Primary DI / UDI-DI
08809262955439
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)