Home / 510(k) Clearances / K895386

510(k) K895386

GLASION by Scientific Pharmaceuticals, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
August 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Scientific Pharmaceuticals, Inc.

  • K192381 — DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (February 18, 2020)
  • K051952 — EUGENONE (September 7, 2005)
  • K041886 — PROVISO (August 4, 2004)
  • K013555 — SCI-PHARM POST SECURE (January 23, 2002)
  • K001446 — LIGHT-CURED ORTHODONTIC BAND CEMENT (July 21, 2000)
  • K993324 — CARBOCEM ZINC POLYCARBOXYLATE CEMENT (November 9, 1999)
  • K982915 — SCI-PHARM DFV VARNISH (February 12, 1999)
  • K983305 — SCI-PHARM DESENSITIZING VARNISH (December 17, 1998)
  • K982913 — ZINFOS ZINC PHOSPHATE CEMENT (October 19, 1998)
  • K944466 — SEALDENT (March 2, 1995)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)