Home / 510(k) Clearances / K853091

510(k) K853091

CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE by Psp Dental Co., Ltd. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
July 23, 1985
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 Psp Dental Co., Ltd.

  • K853089 — SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE (April 21, 1986)
  • K853094 — EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA (April 4, 1986)
  • K853092 — PSP C & B TEMP (April 3, 1986)
  • K853090 — CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO (January 21, 1986)
  • K853093 — PSP TEMP - TRAY (September 6, 1985)

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)