Home / 510(k) Clearances / K242675

510(k) K242675

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) by Spident Co., Ltd. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
September 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Spident Co., Ltd.

  • K250566 — EsCem RMGI (June 20, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)
  • K242702 — VioSeal (November 7, 2024)
  • K241445 — K-Bond Universal (July 22, 2024)
  • K231523 — EsCom250 (July 24, 2023)
  • K214076 — EsCem (December 19, 2022)
  • K214071 — Hexa-Temp (March 10, 2022)
  • K161774 — i-Sil (September 30, 2016)
  • K134022 — BASE IT (June 11, 2014)
  • K134021 — ESTEMP IMPLANT, ESTEMP CLEAR (June 10, 2014)

Other clearances for product code KLE

  • K252450 — Adhese 2 (March 5, 2026)
  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)
  • K241445 — K-Bond Universal (July 22, 2024)