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510(k) K870589

ELEVATOR, ROOT, SINGLE-ENDED by Military Engineering, Inc. — Product Code EMJ

K870589 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "ELEVATOR, ROOT, SINGLE-ENDED". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code EMJ (Elevator, Surgical, Dental), a Class I device regulated under 21 CFR 872.4565. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1987
Date Received
February 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Military Engineering, Inc.

  • K874335 — EXPLORER-DENTAL PROBER (December 29, 1987)
  • K873715 — BONE PIN CUTTER 18 (October 28, 1987)
  • K872842 — PIN, HIP, KNOWLES (August 7, 1987)
  • K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER) (July 31, 1987)
  • K871834 — DRILL, HAND, BONE, SMEDBERG (July 31, 1987)
  • K872738 — CORTICAL BONE SCREWS (July 30, 1987)
  • K872609 — CURETTE SET, ANTRUM, COAKLEY (July 15, 1987)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K870590 — CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY (April 16, 1987)

Other clearances for product code EMJ

  • K851717 — 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR (June 14, 1985)
  • K851713 — 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA (June 11, 1985)
  • K850906 — TACTILE PLUS DENTAL ELEVATORS (April 12, 1985)
  • K821788 — BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT (July 6, 1982)
  • K771747 — PERIOSTEAL ELEVATOR (September 28, 1977)

FDA data resources