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510(k) K782068

MVS UNIT, MODEL SEU-8 AND DEU-8, 80 by Dentsply Intl. — Product Code EHZ

K782068 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "MVS UNIT, MODEL SEU-8 AND DEU-8, 80". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 13, 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 by Dentsply Intl.

  • K140347 — ANKYLOS C/X IMPLANT SYSTEM (August 20, 2014)
  • K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (July 23, 2013)
  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (February 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (February 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (March 27, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)

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