Home / 510(k) Clearances / K901236

510(k) K901236

RUBBER, DENTAL DAM (NON-STERILE) by Naturub Sdn. Bhd. — Product Code EIE

K901236 is an FDA 510(k) premarket notification submitted by Naturub Sdn. Bhd. for the device "RUBBER, DENTAL DAM (NON-STERILE)". The FDA issued a decision of Substantially Equivalent on June 6, 1990. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Naturub Sdn. Bhd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
March 15, 1990
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 Naturub Sdn. Bhd.

  • K892970 — PATIENT EXAMINATION GLOVES (LATEX) (September 18, 1989)
  • K893115 — LATEX EXAMINATION GLOVES (September 13, 1989)

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