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510(k) K892881

DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 by Nieusma R & D, Inc. — Product Code EHZ

K892881 is an FDA 510(k) premarket notification submitted by Nieusma R & D, Inc. for the device "DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Nieusma R & D, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
April 6, 1989
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 Nieusma R & D, Inc.

  • K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (June 23, 1989)
  • K885299 — SANI-SLEEVE DRAPE FOR DENTAL USE (March 16, 1989)

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)
  • K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (June 23, 1989)
  • K880754 — DRI-CLAVE LIQUID KLEENZALL (May 12, 1988)
  • 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