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510(k) K780701

DENTAL OFFICE ENVIRONMENT CONTROL UNIT by Laminaire Corp. — Product Code EHZ

K780701 is an FDA 510(k) premarket notification submitted by Laminaire Corp. for the device "DENTAL OFFICE ENVIRONMENT CONTROL UNIT". The FDA issued a decision of Substantially Equivalent on May 16, 1978. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1978
Date Received
April 26, 1978
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 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)
  • K892881 — DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (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)

FDA data resources