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510(k) K831293

SOLARCRYL CUSTOM TRAY MATERIAL by Solar Dental Co., Inc. — Product Code EBH

K831293 is an FDA 510(k) premarket notification submitted by Solar Dental Co., Inc. for the device "SOLARCRYL CUSTOM TRAY MATERIAL". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. Solar Dental Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 20, 1983
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 Solar Dental Co., Inc.

  • K871980 — D-23 DENTURE ADHESIVE (June 5, 1987)
  • K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (June 26, 1986)
  • K852926 — DENTOLOCK II DENTURE ADHESIVE CREAM (August 23, 1985)
  • K831294 — SOLARCRY/TEMPORARY CROWN & BRIDGE MAT (August 31, 1983)
  • K831265 — DENTOLOCK DENTURE ADHESIVE CREAM (May 9, 1983)

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