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510(k) K880754

DRI-CLAVE LIQUID KLEENZALL by Columbus Dental Mfg. Co. — Product Code EHZ

K880754 is an FDA 510(k) premarket notification submitted by Columbus Dental Mfg. Co. for the device "DRI-CLAVE LIQUID KLEENZALL". The FDA issued a decision of Substantially Equivalent on May 12, 1988. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Columbus Dental Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1988
Date Received
February 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Oral Cavity
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Columbus Dental Mfg. Co.

  • K880607 — UTILITY WAX STRIPS, SPEARMINT (March 31, 1988)
  • K880606 — UTILITY WAX STRIPS, CINNAMON (March 24, 1988)
  • K872243 — PEKALUX(TM) (July 7, 1987)
  • K872272 — PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS (July 2, 1987)
  • K871164 — GLUMA(TM) BONDING SYSTEM (July 2, 1987)
  • K871165 — LUMIFOR(TM) COMPOSITE (April 3, 1987)
  • K863816 — IVORY PREMIUM RUBBER DAM (October 27, 1986)
  • K863758 — ORTHO-BITE WAX WAFER (October 7, 1986)
  • K860855 — SHUR GEL 4 (June 16, 1986)
  • K830083 — SHUR GEL (February 7, 1983)

Other clearances for product code EHZ

  • K973248 — IMTEC BONE COLLECTOR SYSTEM (November 19, 1997)
  • K941164 — TAP EXPRESS EJECTOR (May 18, 1994)
  • K911072 — SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR (May 15, 1991)
  • K903718 — OROSCOPE MODEL NUMBER COS-100 (November 9, 1990)
  • K892881 — DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (June 23, 1989)
  • K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (June 23, 1989)
  • K873545 — PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (November 20, 1987)
  • K874401 — TITANIUM SUCTION TIP (November 12, 1987)
  • K864621 — VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER (February 13, 1987)
  • K863769 — EVACUATOR TIPS (October 30, 1986)

FDA data resources