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510(k) K852522

SATALEC SERVOTOME by Spelna, Inc. — Product Code EKZ

K852522 is an FDA 510(k) premarket notification submitted by Spelna, Inc. for the device "SATALEC SERVOTOME". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Spelna, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

Other clearances by Spelna, Inc.

  • K852525 — SATALEC PIEZOTEC (January 30, 1986)
  • K852527 — SATALEC SEPTOSONIC SC 80/SC 120 (January 3, 1986)
  • K853200 — 5X2 SATALEC CHIROPODY CASE (October 18, 1985)
  • K852521 — SATLEC PROPHY UNIT PU 3055 (July 31, 1985)
  • K852524 — SATALEC SERVOTORQUE S2 SX2 (July 31, 1985)
  • K832674 — SATELEC PROPHY UNIT PU 2000S (March 16, 1984)
  • K832664 — SATELEC SUPRASSON PIEZOMATIC P2 (March 16, 1984)
  • K832665 — SATELEC SUPRASSON SP 3055 (October 19, 1983)
  • K832673 — SATELEC PROPHY UNIT PU-2000 (October 19, 1983)
  • K820256 — MEDILAC #SR4 & SR 40 (June 25, 1982)

Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K982229 — BI-DENT (August 13, 1998)

FDA data resources