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510(k) K952628

ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS by Elastomade Accessories Sdn Bhd — Product Code EIE

K952628 is an FDA 510(k) premarket notification submitted by Elastomade Accessories Sdn Bhd for the device "ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS". The FDA issued a decision of Substantially Equivalent on October 19, 1995. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Elastomade Accessories Sdn Bhd has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
June 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

Other clearances by Elastomade Accessories Sdn Bhd

  • K942992 — ROYAL SHIELD RUBBER DAMS (September 21, 1994)
  • K905470 — STANDARD RUBBER DAM WITH OR WITHOUT FRAMES (April 25, 1991)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)

FDA data resources