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510(k) K853093

PSP TEMP - TRAY by Psp Dental Co., Ltd. — Product Code EBH

K853093 is an FDA 510(k) premarket notification submitted by Psp Dental Co., Ltd. for the device "PSP TEMP - TRAY". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Psp Dental Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1985
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression Tray, Resin
Device Class
Class I
Regulation Number
872.3670
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)
  • K853091 — CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE (January 21, 1986)
  • K853090 — CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO (January 21, 1986)

Other clearances for product code EBH

  • K933745 — PERMAGEN UNIVERSAL BONDING RESIN (January 26, 1994)
  • K930487 — PALATRAY LC MINT (June 18, 1993)
  • K923979 — LC TRAY MATERIAL (November 17, 1992)
  • K923549 — PALADISC LC (September 29, 1992)
  • K912820 — POLYESTER RESIN HAND MOLDED TRAY (August 21, 1991)
  • K905058 — PALAVIT L (June 6, 1991)
  • K902350 — PALATRAY LC RESIN IMPRESSION TRAY MATERIAL (July 26, 1990)
  • K901782 — CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM (June 29, 1990)
  • K890712 — ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS (April 25, 1989)
  • K881838 — MODIFIED PERMAGUM ADHESIVE (July 27, 1988)

FDA data resources