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510(k) K973248

IMTEC BONE COLLECTOR SYSTEM by Imtec Corp. — Product Code EHZ

K973248 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "IMTEC BONE COLLECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on November 19, 1997. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Imtec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1997
Date Received
August 29, 1997
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 Imtec Corp.

  • K081653 — MDI MII ONE-PIECE IMPLANT, 2.9MM (September 19, 2008)
  • K081347 — ILUMA VISION (May 28, 2008)
  • K072660 — ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 (December 12, 2007)
  • K053046 — ILUMA ORTHOCAT/DENTALCAT (November 8, 2005)
  • K043226 — ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (January 13, 2005)
  • K042289 — MDI ORTHO (September 15, 2004)
  • K033432 — LEXATITE QUICK ACRYLIC (January 15, 2004)
  • K031106 — IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, M (August 12, 2003)
  • K030243 — ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 (April 23, 2003)
  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)

Other clearances for product code EHZ

  • 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)
  • 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