Home / 510(k) Clearances / K910813

510(k) K910813

MET-ETCH by Gresco Products, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1991
Date Received
February 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Gresco Products, Inc.

  • K981524 — PRILANE (July 10, 1998)
  • K913405 — KAR-D-TEK (October 28, 1991)
  • K910803 — ENAMEL ETCHING GEL (March 15, 1991)
  • K901973 — CP-3 DENTAL POLISHING MATERIAL (June 1, 1990)
  • K854495 — GRESCO N.P. DENTAL ALLOY (December 27, 1985)
  • K854494 — CERAM-ETCH (December 23, 1985)

Other clearances for product code EBC

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)