Home / 510(k) Clearances / K853092

510(k) K853092

PSP C & B TEMP by Psp Dental Co., Ltd. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1986
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
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)
  • K853091 — CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE (January 21, 1986)
  • K853090 — CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO (January 21, 1986)
  • K853093 — PSP TEMP - TRAY (September 6, 1985)

Other clearances for product code EBG

  • K253380 — “FLNT Base” and “FLNT Temp” (March 2, 2026)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • K243370 — DentaTOOTH (May 5, 2025)
  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
  • K231859 — PrimmaArt (November 26, 2024)
  • K242559 — Digital Temp (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)